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31990L0533 | 1990 | Council Directive 90/533/EEC of 15 October 1990 amending the annex to Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (1), as last amended by Directive 89/365/EEC (2), and in particular Article 6 (3) thereof,
Having regard to the proposal from the Commission,
Whereas Directive 79/117/EEC provides for the contents of the Annex thereto to be regularly amended to take account of the developments of scientific and technical knowledge;
Whereas it has been established that the uses of dinoseb, its acetate and salts in plant protection products are likely to give rise to harmful effects on human and animal health as well as unreasonable adverse influence on the environment;
Whereas it has also been established that the uses of binapacryl and captafol in plant protection products are likely to give rise to harmful effects on human and animal health;
Whereas it has also been established that the uses of dicofol, maleic hydrazide and quintozene which do not comply with certain purity criteria are likely to give rise to harmful effects on human and animal health as well as a highly unfavourable influence on the environment;
Whereas, given the present state of harmonization pursuant to Directive 79/117/EEC, Member States may prohibit the placing on the market, and the use, of active substances not listed in the Annex to the Directive, or of active substances with a degree of purity higher than the level referred to therein, provided that the provisions of the Treaty as well as general principles of law, and notably the principles of non-discrimination and proportionality, are strictly complied with;
Whereas the Annex to Directive 79/117/EEC should therefore be supplemented,
Article 1
The Annex to Directive 79/117/EEC is hereby amended by adding the following entries to 'C. Other compounds':
'5. Dinoseb, its acetate and salts
6. Binapacryl
7. Captafol
8. Dicofol containing less than 78 % of p.p.1-dicofol or more than 1 g/kg DDT and DDT related compounds
9. (a) Maleic hydrazide and its salts, other than its choline, potassium and sodium salts;
(b) Choline, potassium and sodium salts of maleic hydrazide containing more than 1 mg/kg of free hydrazine expressed on the basis of the acid equivalent
10. Quintozene containing more than 1 g/kg of HCB or more than 10 g/kg pentachlorobenzene'
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 September 1991 for the compound referred to under 8 of heading C of the Annex to Directive 79/117/EEC, as amended by this Directive, and 31 December 1990 for the other compounds. They shall forthwith inform the Commission thereof.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19861510"
] |
31990L0539 | 1990 | Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43
thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas poultry, being live animals, and hatching eggs, being animal products, are included in the list of products in Annex II to the Treaty;
Whereas, in order to ensure the rational development of poultry production, thereby increasing productivity in that sector, certain animal health rules governing intra-Community trade in poultry and hatching eggs must be laid down at Community level;
Whereas the breeding and rearing of poultry is included in the farming sector; whereas it constitutes a source of income for part of the farming population;
Whereas disparities as regards animal health conditions in the Member States should be eliminated in order to encourage intra-Community trade in poultry and hatching eggs, thus contributing to the completion of the internal market;
Whereas, in order to encourage the harmonious development of intra-Community trade, a Community system should be laid down to govern import from third countries;
Whereas the provisions of this Directive should not, in principle, apply to specific trade such as exhibitions, shows and contests;
Whereas this Directive should cover trade in quails, pigeons, ducks, pheasants and partridges reared for breeding or consumption;
Whereas, in view of the nature of modern poultry farming, the best way to promote the harmonious development of intra-Community trade in poultry and hatching eggs is to monitor production establishments;
Whereas it should be left to the competent authorities of the Member States to approve establishment which satisfy the conditions laid down in this Directive and to ensure that the conditions are applied;
Whereas Council Regulation (EEC) No 2782/75 of 29 October 1975 on the production and marketing of eggs for hatching and of farmyard poultry chicks (4), as last amended by Regulation (EEC) No 3987/87 (5), provides for the granting of a distinguishing registration number to each production establishment and for the marking of hatching eggs; whereas Commission Regulation (EEC) No 1868/77 (6), as last amended by Regulation (EEC) No 1351/87 (7), lays down detailed rules for the application
of the said Regulation; whereas, for practical reasons, the same criteria for identifying production establishments and marking hatching eggs should be adopted for the purposes of this Directive;
Whereas, in order to be the subject of intra-Community trade, poultry and hatching eggs must satisfy certain animal health requirements, so as to avoid the spread of contagious diseases;
Whereas, however, it is appropriate to postpone laying down the control rules applicable to combating avian influenza and Newcastle disease;
Whereas transport conditions should be laid down for the same reason;
Whereas provision should be made for allowing the Commission to approve certain additional requirements in the light of the progress made by a Member State in eradicating certain poultry diseases, provided that those requirements in no case exceed those applied nationally by the Member State concerned; whereas, in this context, it could prove desirable to determine the status of the Member States or regions thereof with regard to certain diseases likely to affect poultry;
Whereas, although intra-Community trade transactions in very small quantities cannot, for practical reasons, be subject to all the Community requirements, certain essential rules should be complied with;
Whereas, to ensure that the prescribed requirements are satisfied, provision must be made for the issue by an official veterinarian of a health certificate to accompany the poultry and hatching eggs to their destination;
Whereas, in respect of the organization of, and the follow-up to, the checks to be carried out by the Member State of destination and the safeguard measures to be implemented, reference should be made to the general rules laid down in Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (8);
Whereas provision should be made for checks to be carried out by the Commission in cooperation with the competent authorities of Member States;
Whereas defining Community arrangements applicable to imports from third countries requires a list to be drawn up of third countries or parts of third countries from which poultry and hatching eggs may be imported;
Whereas the choice of these countries must be based on criteria of a general nature such as the state of health of the
poultry and other livestock, the organization and powers of the veterinary services and the health regulations in force;
Whereas, in addition, importation of poultry and hatching eggs should not be authorized from countries which are infected with contagious poultry diseases presenting a risk to Community livestock or which have been free from such diseases for too short a period;
Whereas the general conditions applicable to importation from third countries must be supplemented by special conditions drawn up on the basis of the health situation in each of them; whereas, owing to the technical nature and the diversity of the criteria on which these special conditions depend, recourse must be had, in order to define them, to the Standing Veterinary Committee;
Whereas the presentation of a standard form of certificate upon importation of poultry and hatching eggs constitutes an effective means of verifying that the Community rules are being applied; whereas such rules may include special provisions which may vary according to the third country concerned; whereas this must be taken into account in drawing up the standard forms of certificate;
Whereas Commission veterinary experts should be responsible for verifying that the rules are observed in third countries;
Whereas the checks carried out upon importation must cover the origin and the state of health of the poultry and hatching eggs;
Whereas Member States must be allowed, on the arrival of poultry and hatching eggs in the territory of the Community and during transit to their place of destination, to take all measures, including slaughter and disposal, required for the purpose of safeguarding public and animal health;
Whereas the rules and general principles governing checks on poultry and hatching eggs will be determined later as part of the measures to be taken to bring about the internal market;
Whereas every Member State must have the right to place an immediate prohibition on imports from a third country when such imports may be dangerous for human and animal health; whereas, in such a case, coordination of the attitudes of the Member States with regard to that third country must be ensured without delay, without prejudice to possible amendments to the list of countries authorized to export to the Community;
Whereas the constant development of poultry-rearing techniques means that periodic changes in the methods of poultry-disease control will have to be made;
Whereas the provisions of this Directive should be revised in connection with the completion of the internal market;
Whereas provision should be made for a procedure establishing close cooperation between the Member States and the Commission within the Standing Veterinary Committee,
CHAPTER I
General provisions
Article 1
1. This Directive lays down animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs.
2. This Directive shall not apply to poultry for exhibitions, show or contests.
Article 2
For the purposes of this Directive 'official veterinarian' and 'third country' shall mean the official veterinarian and third country referred to in Directive 72/462/EEC.
In addition:
1. 'poultry' shall mean fowl, turkeys, guinea fowl, ducks, geese, quails, pigeons, pheasants and partridges reared or kept in captivity for breeding, the production of meat or eggs for consumption, or for re-stocking supplies of game;
2. 'hatching eggs' shall mean eggs for incubation, laid by poultry as defined in 1;
3. 'day-old chicks' shall mean all poultry less than 72 hours old, not yet fed; however, Barbary ducks may be fed;
4. 'breeding poultry' shall mean poultry 72 hours old or more, intended for the production of hatching eggs;
5. 'productive poultry' shall mean poultry 72 hours old or more, reared for the production of meat and/or eggs for consumption (or for restocking supplies of game);
6. 'slaughter poultry' shall mean poultry sent direct to a slaughterhouse for slaughter as soon as possible after arrival, and in any case within 72 hours;
7. 'flock' shall mean all poultry of the same health and immunity status, reared on the same premises or in the same enclosure and constituting a single zootechnical unit;
8. 'holding' shall mean a facility - which may include an establishment - used for the rearing or keeping of breeding or productive poultry;
9. 'establishment' shall mean a facility or part of a facility which occupies a single site and is devoted to the following activities:
(a) pedigree breeding establishment: an establishment which produces hatching eggs for the production of breeding poultry;
(b)
breeding establishment: an establishment which produces hatching eggs for the production of productive poultry:
(c)
rearing establishment: an establishment which rears poultry until the laying stage;
(d)
hatchery: an establishment which incubates and hatches eggs and supplies day-old chicks:
10. 'authorized veterinarian' shall mean a veterinarian instructed by the competent veterinary authority, under its responsibility, to carry out the checks provided for in this Directive in a particular establishment;
11. 'approved laboratory' shall mean a laboratory located in the territory of a Member State, approved by the competent veterinary authority, under its responsibility, for the purpose of carrying out the diagnostic tests provided for in this Directive;
12. 'health inspection' shall mean a visit by the official veterinarian or authorized veterinarian for the purpose of inspecting the health status of all the poultry in an establishment;
13. 'compulsorily notifiable diseases' shall mean the diseases listed in Annex V;
14. 'outbreak site' shall mean a site as defined in Directive 82/894/EEC;
15. 'infected area' for the diseases listed in Annex V shall mean either a zone comprising, depending on the epizootiological environment of the outbreak site, a well-defined territory, or a protection zone with a radius of at least 3 kilometres around the outbreak site, which is itself included in a surveillance zone of a radius of at least 10 kilometres;
16. 'quarantine station' shall mean facilities where the poultry is kept in complete isolation and away from direct or indirect contact with other poultry, so as to permit long-term observation and testing for the diseases listed in Annex V;
17. 'sanitary slaughter' shall mean the destruction, subject to all the necessary health safeguards including disinfection, of all poultry and products at the outbreak site which are infected or suspected of being contaminated.
CHAPTER II
Rules for intra-Community trade
Article 3
1. Member States shall submit to the Commission by 1 July 1991 a plan describing the national measures which they
intend to implement to ensure compliance with the rules set out in Annex II for the approval of establishments for the purposes of intra-Community trade in poultry and hatching eggs.
2. The Commission shall examine the plans. In accordance with the procedure laid down in Article 32, the plans may be approved, or amendments or additions made, before approval is given.
3. In accordance with the procedure referred to in paragraph 2, amendments or additions to a plan which has been approved in accordance with the said paragraph may be:
- approved at the request of the Member State concerned, in order to take account of a change in the situation in that Member State, or
- requested, in order to take account of progress in methods of disease prevention and control.
Article 4
Each Member State shall designate a national reference laboratory to be responsible for coordinating the diagnostic methods provided for in this Directive and their use by the approved laboratories located in its territory. These reference laboratories are listed in Annex I.
Article 5
In order to be traded within the Community:
(a) hatching eggs, day-old chicks, breeding poultry and productive poultry must satisfy the conditions laid down in Articles 6, 12, 15 and 17 and, respectively, those laid down pursuant to Articles 13 and 14 or those laid down in Articles 7, 8 and 9;
(b)
slaugther poultry and, by way of derogation from (a), poultry intended for restocking supplies of game, until the implementation of animal health conditions governing intra-Community trade and the import from third countries of fresh poultry meat and game birds for rearing, must fulfil the conditions set out in Articles 10, 12, 15 and 17 and those laid down pursuant to Articles 13 and 14.
Article 6
Hatching eggs, day-old chicks, breeding poultry and productive poultry must come from:
1. establishments which fulfil the following requirements:
(a) they must be approved and given a distinguishing number by the competent authority, in accordance with the rules set out in Chapter I of Annex II;
(b) they must not, at the time of consignment, be the subject of any animal health restrictions applicable to poultry;
(c) they must not be located in an infected area;
2. a flock which, at the time of consignment, presents no clinical sign or suspicion of disease.
Article 7
At the time of consignment, hatching eggs must:
1. if they come from a Member State, meet the following requirements:
(a) come from flocks which:
- have been held for more than six weeks in one or more Community establishments as defined in Article 6 (1) (a),
- if there is a vaccination requirement, have been vaccinated in accordance with the vaccination conditions in Annex III;
- have undergone an animal health examination carried out by an official veterinarian or an authorized veterinarian during the 24 hours preceding consignment and, at the time of the examination, have shown no clinical sign or suspicion of disease;
(b) be marked in accordance with Commission Regulation (EEC) No 1868/77;
(c) have been desinfected in accordance with the instructions of the official veterinarian;
2. if they come from third countries, have been imported in accordance with the conditions set out in Chapter III.
Article 8
Day-old chicks must:
(a) have been hatched from hatching eggs satisfying the requirements of Articles 6 and 7;
(b)
satisfy the vaccination conditions in Annex III, if there is a vaccination requirement;
(c)
present, at the time of consignment, no suspicion of diseases on the basis of Annex II, Chapter II, B 2 (g) and (h).
Article 9
At the time of consignment, breeding poultry and productive poultry must:
(a)
have been held since hatching or for more than six weeks in one or more Community establishments as defined in Article 6 (1) (a);
(b)
if there is a vaccination requirement, satisfy the vaccination conditions in Annex III;
(c)
have been submitted to a health examination by an official or authorized veterinarian during the 24 hours preceding consignment and, at the time of the examination, have presented no clinical sign or suspicion of disease.
Article 10
At the time of the consignment, slaughter poultry must have come from a holding:
(a)
where they have been held since hatching or for more than 21 days;
(b)
which is not the subject of any animal health restrictions applicable to poultry;
(c)
where the health examination carried out by the official or authorized veterinarian during the 48 hours preceding dispatch on the flock from which the consignment to be slaughtered is to be drawn has not revealed within that flock any clinical sign or suspicion of disease;
(d)
which is not located in an area infected with avian influenza or Newcastle disease, to be defined in the framework of the measures to combat these diseases to be adopted in accordance with Article 19.
Article 11
1. The requirement of Articles 5 to 10 and 15 shall not apply to intra-Community trade in poultry and hatching eggs in respect of consignments comprising fewer than 20 units.
2. However, poultry and hatching eggs as referred to in paragraph 1 must, at the time of consignment, have come from flocks which:
- have been held in the Community since hatching or for at least three months,
- present no clinical signs of a contagious poultry disease at the time of consignment,
- if there is a vaccination requirement, satisfy the vaccination conditions in Annex III,
- are not the subject of any animal health restrictions applicable to poultry,
- are not located in an area infected with avian influenza or Newcastle disease, to be defined in the framework of the measures to combat these diseases to be adopted in accordance with Article 19,
- have been found negative in serological tests for Salmonella pullorum et gallinarum antibodies, in accordance with Annex II, Chapter III.
Article 12
1. In the case of consignment of poultry and hatching eggs from Member States or regions of Member States which
vaccinate the poultry referred to in Article 1 against Newcastle disease to a Member State or region of a Member State the status of which has been established in accordance with paragraph 2 below the following rules shall apply:
(a) hatching eggs must come from flocks which are:
- not vaccinated, or
- vaccinated using an inactivated vaccine, or
- vaccinated using a live vaccine, provided that vaccination has taken place at least 60 days before the collection of the hatching eggs;
(b)
day-old chicks must come from:
- hatching eggs satisfying the conditions in (a),
- a hatchery where working practices ensure that such eggs are incubated at completely separate times and locations from eggs not satisfying the conditions in (a);
(c)
breeding and productive poultry must:
- not be vaccinated against Newcastle disease, and
- have been isolated for 14 days before consignment, at either a holding or a quarantine station under the supervision of the official veterinarian. In this connection, no fowl at the holding of origin or quarantine station, as applicable, may have been vaccinated against Newcastle disease during the 21 days preceding consignment and no bird which is not due for consignment may have entered the holding or the quarantine station during that time; in addition, no vaccinations may be carried out in the quarantine stations, and
- have undergone, during the 14 days preceding consignment, representative serological testing to detect Newcastle disease antibodies in accordance with detailed rules adopted pursuant to the procedure laid down in Article 32;
(d)
slaughter poultry must come from flocks which:
- if not vaccinated against Newcastle disease, satisfy the requirement in the third indent of (c),
- if vaccinated, have not been vaccinated with a live vaccine during the 30 days preceding consignment and have undergone, during the 14 days preceding consignment and on the basis of a representative sample, a test to isolate the Newcastle disease virus complying with detailed rules adopted in accordance with the procedure laid down in Article 32.
2. The status of Member States or regions of Member States from the point of view of Newcastle disease shall be established by the Commission, in accordance with the procedure provided for in Article 32, at the latest six months before the date on which the Member States must conform to
this Directive. The elements to be taken into consideration for determining this status shall be the data referred to in Article 14 (1) and, in particular, the following criteria:
- no Newcastle disease shall have been detected in the poultry referred to in Article 1 for at least the preceding 12 months,
- vaccination against Newcastle disease in the poultry referred to in Article 1 shall not have been authorized for at least the preceding 12 months,
- all breeding flocks shall have been monitored at least once a year for the presence of Newcastle disease,
- the holdings shall contain no poultry which have been vaccinated against Newcastle disease.
3. The conditions referred to in paragraph 1 shall be reviewed before 31 December 1992.
Article 13
1. Where a Member State draws up or has drawn up a voluntary or compulsory control programme for a disease to which poultry are susceptible, it may present the programme to the Commission, outlining in particular:
- the distribution of the disease in its territory,
- the reasons for the programme, taking into consideration the importance of the disease and the programme's likely benefit in relation to its cost,
- the geographical area in which the programme will be implemented,
- the status categories to be applied to poultry establishments, the standards which must be attained in each category, and the test procedures to be used,
- the programme monitoring procedures,
- the action to be taken if, for any reason, an establishment loses its status,
- the measures to be taken if the results of the tests carried out in accordance with the provisions of the programme are positive.
2. The Commission shall examine the programmes presented by the Member States. The programmes may be approved, in compliance with the criteria referred to in paragraph 1, in accordance with the procedure laid down in Article 32. Any additional guarantees, general or specific, which may be required in intra-Community trade may be
defined in accordance with the same procedure. Such guarantees must not exceed those required by the Member State in its own territory.
In the case of programmes presented to the Commission before 1 July 1991, decisions as to their approval and additional trade guarantees shall be taken before 1 January 1992.
3. Programmes submitted by Member States may be amended or supplemented in accordance with the procedure laid down in Article 32. Amendments or additions to programmes which have already been approved or to guarantees which have been defined in accordance with paragraph 2 may be approved under the same procedure.
Article 14
1. Where a Member State considers that its territory or part of its territory is free from one of the diseases to which poultry are susceptible, it shall present to the Commission appropriate supporting documentation, setting out in particular:
- the nature of the disease and the history of its occurrence in that Member State,
- the results of surveillance testing based on serological, microbiological or pathological investigations and on the fact that the disease must by law be notified to the competent authorities,
- the period over which the surveillance was carried out,
- where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by the prohibition,
- the arrangements for verifying that the area concerned remains free from the disease.
2. The Commission shall examine documentation submitted by Member States. The additional guarantees, general or specific, which may be required in intra-Community trade may be defined in accordance with the procedure laid down in Article 32. Such guarantees must not exceed those required by the Member State in its own territory. Where justification is submitted before 1 July 1991, decisions on additional guarantees shall be taken before 1 January 1992.
3. The Member State concerned shall notify the Commission of any change in the particulars specified in paragraph 1. The guarantees defined as laid down in paragraph 2 may, in the light of such notification, be amended or withdrawn in accordance with the procedure laid down in Article 32.
Article 15
1. Day-old chicks and hatching eggs must be transported either in purpose-designed disposable boxes, or in boxes
which may be re-used provided they are disinfected beforehand. Such boxes must be cleaned and:
(a) contain only day-old chicks or hatching eggs of the same species, category and type of poultry, coming from the same establishment;
(b)
bear the following indications:
- the name of the Member State of consignment,
- the species of poultry to which the eggs or chicks belong,
- the number of chicks or eggs,
- the category and type of production for which they are intended,
- the name or business name, address and approval number of the production establishment,
- the establishment of origin's approval number, as provided for in Annex II, Chapter I (2),
- the Member State of destination;
(c)
be closed in accordance with the instructions of the competent authority in such a way as to avoid any possibility of substitution of the contents.
2. Boxes holding day-old chicks or hatching eggs may be grouped for transport in appropriate containers. The number of boxes thus grouped and the indications referred to in paragraph 1 (b) must be shown on those containers.
3. Breeding and productive poultry must be transported in crates or cages:
- which contain only poultry of the same species, categories and type, coming from the same establishment,
- bearing the approval number of the establishment of origin as provided for in Annex II, Chapter I (2),
- which are closed in accordance with the instructions of the competent authority in such a way as to avoid any possibility of substitution of the contents.
4. (a) Breeding and productive poultry and day-old chicks must be conveyed without delay to the establishment of destination, without coming into contact with other live birds, except breeding and productive poultry or day-old chicks satisfying the conditions laid down in this Directive.
(b)
Slaughter poultry must be conveyed without delay to the slaughterhouse of destination, without coming into contact with other poultry, except slaughter poultry satisfying the conditions laid down in this Directive.
5. Crates, cages and vehicles must be designed so as to:
- preclude the loss of excrement and minimize the loss of feathers during transit,
- allow visual inspection of the poultry,
- allow cleansing and disinfection.
6. The vehicles and, if they are not disposable, the containers, crates and cages must, before loading and unloading, be cleansed and disinfected in accordance with the instructions of the competent authority of the Member State concerned.
Article 16
Poultry as referred to in Article 15 (4) may not be transported through areas infected with avian influenza or Newcastle disease, unless by trunk road or rail.
Article 17
In trade between Member States, poultry and hatching eggs must, during transportation to the place of destination, be accompanied by a health certificate which:
- conforms with the appropriate model in Annex IV,
- is signed by an official veterinarian,
- is drawn up on the date of loading in the language or languages of the Member State of dispatch and in the official language or languages of the Member State of destination,
- is valid for five days,
- consists of a single sheet,
- is normally made out for a single consignee,
- bears a stamp of a colour different from that of the certificate.
Article 18
The Member States of destination may, in compliance with the general provisions of the Treaty, grant one or more Member States of dispatch general authorizations or authorizations limited to specific cases permitting entry into their territory of poultry and hatching eggs without the certificate provided for in Article 17.
Article 19
The Council, acting by a qualified majority on a proposal from the Commission, shall, before 1 July 1991, adopt the control rules for combating avian influenza and Newcastle disease.
CHAPTER III
Rules for imports from third countries
Article 20
Poultry and hatching eggs imported into the Community must satisfy the conditions laid down in Articles 21 to 24.
Article 21
1. Poultry and hatching eggs must have originated in a third country or part of a third country included on a list drawn up by the Commission in accordance with the
procedure laid down in Article 32. That list may be supplemented or amended in accordance with the procedure laid down in Article 33.
2. In deciding whether a third country or part thereof may be included on the list referred to in paragraph 1, particular account shall be taken of:
(a) the state of health of the poultry, other domestic animals and wildlife in the third country, particular attention being paid to exotic animal diseases, and the health situation in the surrounding area, where either is liable to endanger public and animal health in the Member States;
(b)
the regularity and rapidity of the supply of information by the third country relating to the existence of contagious animal diseases in its territory, in particular the diseases on Lists A and B of the International Office of Epizootics;
(c)
the country's rules on animal-disease prevention and control;
(d)
the structure of the veterinary services in the country and their powers;
(e)
the organization and implementation of measures to prevent and control contagious animal diseases;
(f)
the guarantees which the third country can give with regard to compliance with this Directive;
(g)
compliance with Community rules on hormones and residues.
3. The list referred to in paragraph 1 and any amendments thereto shall be published in the Official Journal of the European Communities.
Article 22
1. Poultry and hatching eggs must come from countries free from avian influenza and Newcastle disease.
2. The general criteria for classifying the third country from the point of view of the diseases shall be adopted in accordance with the procedure laid down in Article 32.
3. The Commission may, in accordance with the procedure laid down in Article 32, decide that the provisions of paragraph 1 of this Article shall apply to only a part of the territory of a third country.
Article 23
1. Poultry and hatching eggs may be imported from the territory of a third country or part of the territory of a third country included on the list drawn up in accordance with Article 21 (1) only if they come from flocks which:
(a) prior to consignment have been held without interruption in the territory or part of the territory concerned of such country for a period to be determined in accordance with the procedure laid down in Article 32;
(b)
satisfy the animal health conditions adopted in accordance with the procedure laid down in Article 32 for imports of poultry and hatching eggs from the country in question. The conditions may differ according to the species or category of poultry.
2. The animal health conditions shall be determined on the basis of the rules laid down in Chapter II and its corresponding Annexes. In accordance with the procedure laid down in Article 32, derogations may be granted on a case-by-case basis if the third country concerned offers similar animal health guarantees which are at least equivalent.
Article 24
1. Poultry and hatching eggs must be accompanied by a certificate drawn up and signed by an official veterinarian of the exporting third country.
The certificate must:
(a) be issued on the day of loading for consignment to the Member State of destination;
(b)
be drawn up in the official language or languages of the Member State of destination;
(c)
accompany the consignment in the original;
(d)
attest to the fact that the poultry or hatching eggs satisfy the requirements of this Directive and those adopted pursuant to this Directive with regard to importation from third countries;
(e)
be valid for five days;
(f)
consist of a single sheet;
(g)
be made out for a single consignee;
(h)
bear a stamp of a colour different from that of the certificate.
2. The certificate referred to in paragraph 1 must comply with a model drawn up in accordance with the procedure laid down in Article 32.
Article 25
On-the-spot inspections shall be carried out be veterinary experts of the Member States and the Commission to ensure that all the provisions of this Directive are effectively applied.
The Member States' experts responsible for these inspections shall be designated by the Commission on proposals for the Member States.
The inspections shall be carried out on behalf of the Community, and the latter shall bear the costs thereof.
The frequency of the inspections and the inspection procedure shall be determined in accordance with the procedure laid down in Article 32.
Article 26
1. The Commission may, in accordance with the procedure laid down in Article 33, decide that imports from a third country or part of a third country are to be confined to particular species, to hatching eggs, to poultry for breeding or production, to slaughter poultry or to poultry intended for special purposes.
2. The Commission may decide, in accordance with the procedure laid down in Article 33, to apply animal health restrictions, as required, after importation.
Article 27
1. The rules and general principles applicable during inspections in third countries or during inspections of imported poultry from third countries shall be determined in accordance with the second subparagraph of Article 19 (1) of Directive 89/662/EEC.
Pending implementation of the abovementioned rules and principles, the national rules shall remain in force, subject to compliance with the general rules of the Treaty.
2. Poultry and hatching eggs may not be imported into the Community if:
- the consignment does not come from the territory or part of the territory of a third country on the list drawn up pursuant to Article 21 (1),
- the consignment is, or is suspected of being, infected with, or contaminated by, a contagious disease,
- the conditions laid down in this Directive have not been complied with by the exporting third country,
- the certificate accompanying the consignment does not comply with the conditions set out in Article 24,
- examination reveals that Community rules on hormones and residues have not been complied with.
3. Without prejudice to any special conditions which may be adopted in accordance with the procedure laid down in Article 26, for reasons of animal health or where permission to send back poultry the entry of which has been refused pursuant to paragraph 1 has not been granted, the competent authority of the Member State of destination may designate the slaughterhouse which must accept such poultry.
Article 28
On arrival in the Member State of destination, slaughter poultry must be taken directly to a slaughterhouse for slaughter as soon as possible.
Without prejudice to any special conditions which may be adopted in accordance with the procedure laid down in Article 33, the competent authority of the Member State of destination may, on animal-health grounds, designate the slaughterhouse to which the poultry must be conveyed.
CHAPTER IV
Common provisions
Article 29
1. For the purposes of intra-Community trade, the safeguard measures provided for in Directive 89/662/EEC shall apply to poultry and hatching eggs.
2. For the purposes of imports from third countries, the following safeguard measures shall apply:
(a) Without prejudice to Article 22, if a contagious poultry disease likely to endanger the health of poultry of one of the Member States appears in or extends to a third country or if any other animal-health reason justifies it, the Member State concerned shall prohibit imports of animals of the species covered by this Directive coming directly or indirectly via another Member State either from the third country as a whole or from part of the territory thereof.
(b)
The measures taken by the Member States on the basis of this Article, together with their repeal, shall be communicated without delay to the other Member State and the Commission and the reasons therefore shall be indicated.
The Standing Veterinary Committee shall meet as soon as possible following such communication and shall decide, in accordance with the procedure laid down in Article 32, whether these measures require amendment in order, particularly, to be coordinated with measures taken by the other Member States or whether they should be discontinued.
Should the situation provided for in this Article occur and other Member States also need to apply the measures taken thereunder, possibly amended in accordance with the preceding subparagraph, the appropriate provisions shall be adopted in accordance with the procedure laid down in Article 32.
(c)
The resumption of imports from the third country concerned shall be authorized under the same procedure.
Article 30
1. The veterinary control rules provided for by Directive 90/425/EEC shall apply to intra-Community trade in poultry and hatching eggs.
2. Directive 90/425/EEC shall be amended as follows:
(a) In Annex A, under I, the following reference shall be added:
'Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs
OJ No L 303, 31. 10. 1990, p. 6.'
(b)
In Annex B the following indents shall be deleted:
'- live poultry',
'- eggs for hatching'.
Article 31
Until the date of entry into force of the decisions adopted pursuant to Articles 20, 21 and 22, the Member States shall apply to imports of poultry and hatching eggs from third countries conditions at least equivalent to those resulting from the application of Chapter II.
Article 32
1. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter forthwith to the Standing Veterinary Committee either on his own initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
4. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, within three months of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority.
Article 33
1. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter forthwith to the Standing Veterinary Committee either on his initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within two days. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
4. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, within 15 days of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority.
Article 34
Amendments to the Annexes, particularly in order to adapt them to changes in diagnostic methods and to variations in the economic importance of particular diseases, shall be decided by the Commission in accordance with the procedure laid down in Article 32.
Article 35
The provisions of this Directive and Article 29 in particular shall be reviewed before 31 December 1992 in the light of proposals concerning the completion of the internal market.
Article 36
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 January 1992. They shall forthwith inform the Commission thereof.
Article 37
This Directive is addressed to the Member States. | [
"UKSI19923295",
"UKSI19791702"
] |
31990L0612 | 1990 | Commission Directive 90/612/EEC of 26 October 1990 amending Council Directive 78/663/EEC laying down specific purity criteria for emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3 (3) thereof,
Whereas it is necessary to take into consideration the revised Codex Alimentarius specifications for substances E407 and E466, authorize new techniques for the production of E473 and draw a distinction between substance E407 as described in the Annex to Council Directive 78/663/EEC (2), as amended by Directive 82/504/EEC (3), and similar products not covered by that Annex;
Whereas the Scientific Committee for Food has been consulted, in accordance with Article 6 of Directive 89/107/EEC, on those provisions likely to affect public health;
Whereas the measures laid down by this Directive comply with the opinion of the Standing Committee on Foodstuffs,
Article 1
The Annex to Directive 78/663/EEC is hereby amended as set out in the Annex to this Directive.
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 12 months after notification of the present Directive. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19920165"
] |
31990L0547 | 1990 | Council Directive 90/547/EEC of 29 October 1990 on the transit of electricity through transmission grids
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas it is necessary to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the European Council has recognized, at its successive meetings, in particular in Rhodes, the need for a single internal market in energy and whereas the achievement of the internal market more specifically in the electricity sector will help the further development of the Community's energy objectives;
Whereas there must be greater integration of the European energy market if the single inertnal market is to be achieved; whereas electricity is an essential component of the Community's energy balance;
Whereas the achievement of the internal market for energy, more particularly in the electricity sector, must take into account the objective of economic and social cohesion, that is to say, in concrete terms, guarantee an optimum supply of electricity to all the citizens of all the Community regions, with a view to improving and harmonizing the living conditions and development bases in particular in the least-favoured regions;
Whereas energy polices, more than any other measure contributing to the achievement of the internal market, must not be implemented with the sole aim of reducing costs and maintaining competition, but must also take account of the need to ensure the security of supplies and the compatibility of energy production methods with the environment;
Whereas to attain that objective, account should be taken of the specific characteristics of the electricity sector;
Whereas there is increasing trade in electricity each year between high-voltage electricity grids in Europe; whereas the European Community's security of electricity supply would be improved and costs reduced by coordinating the building and operation of the interconnections required for such trade;
Whereas the exchange of electricity between electricity grids which is based on contracts with a minimum duration of one year is so great that requests for transactions and their consequences should be systematically known to the Commission;
Whereas it is possible and desirable to increase electricity transfers between grids and also take account of the imperatives of security and quality of electricity supply; whereas studies show that such greater electricity transfers between grids can minimize the cost of investment and fuels involved in electricity generation and transmission and ensure optimum use of the means of production and infrastructure;
Whereas there are still obstacles to such trade; whereas, provided that they are not due to the nature of technology used or the nature of the grids themselves, such obstacles can be reduced by making the transit of electricity through grids compulsory and introducing an appropriate system for monitoring compliance with this obligation;
Whereas this obligation and monitoring system concern the transit of electricity involved in trade with is in the Community interest, i.e. transit through high-voltage grids;
Whereas the contract conditions concerning the transit of electricity between grids must be negotiated between the responsible entities; whereas the conditions of transit should be fair and should not bring about, directly or indirectly, conditions contrary to Community competition rules;
Whereas, in order to facilitate the conclusion of transit contracts, the Commission is providing for the creation of a conciliation procedure under which submission must be made at the request of one of the parties, without the result of that procedure having legally binding effect;
Whereas it is necessary to approximate the provisions taken by the Member States which affect the transit of electricity;
Whereas the establishment of an internal electricity market will stimulate the dynamic process of better integration of national electricity grids, and whereas in this context special infrastructure measures and programmes should therfore be implemented to accelerate the efficient and socially advantageous linking-up of outlying areas and islands in the Community to the interconnected grid;
Whereas the interconnection of major European grids over which trade must be coordinated extends over a geographical territory which does not coincide with the Community's frontiers; whereas there is an obvious advantage in seeking cooperation with third countries involved in the interconnected European network,
Article 1
Member States shall take the measures necessary to facilitate transit of electricity between high-voltage grids in accordance with the conditions laid down in this Directive.
Article 2
1. Every transaction for the transport of electricity under the following conditions shall constitute transit of electricity between grids, within the meaning of this Directive, without prejudice to any special arrangements concluded between the Community and third countries:
(a) transmission is carried out by the entity or entities responsible in each Member State for a high-voltage electricity grid, with the exception of distribution grids, in a Member State's territory which contributes to the efficient operation of European high-voltage interconnections;
(b) the grid of origin or final destination is situated in the Community;
(c) the transport involves the crossing of one intra-Community frontier at least.
2. The high-voltage electricity transmission grids and the entities responsible for them in the Member States, which are listed in the Annex, shall be covered by the provisions of this Directive. This list shall be updated after consultation with the Member State concerned whenever necessary by decision of the Commission, within the context of the objectives of this Directive and in particular taking into account paragraph 1 (a).
Article 3
1. Contracts involving transit of electricity between transmission grids shall be negotiated between the entities responsible for the grids concerned and for the quality of service provided and, where appropriate, with the entities responsible in the Member States for importing and exporting electricity.
2. The conditions of transit shall, pursuant to the rules of the Treaty, be non-discriminatory and fair for all the parties concerned, shall not include unfair clauses or unjustified restrictions and shall not endanger security of supply and quality of service, in particular taking full account of the utilization of reserve production capacity and the most efficient operation of existing systems.
3. Member States shall take the measures necessary to ensure that the entities under their jurisdiction referred to in the Annex act without delay to:
- notify the Commission and the national authorities concerned of any request for transit in connection with contracts for the sale of electricity of a minimum of one year's duration,
- open negotiations on the conditions of the electricity transit requested,
- inform the Commission and the national authorities concerned of the conclusion of a transit contract,
- inform the Commission and the national authorities concerned of the reasons for the failure of the negotiations to result in the conclusion of a contract within 12 months following communication of the request. 4. Each the entities concerned may request that the conditions of transit be subject to conciliation by a body set up and chaired by the Commission and on which the entities responsible for transmission grids in the Community are represented.
Article 4
If the reasons for the absence of agreement on a request for transit appear unjustified or insufficient, the Commission, acting on a complaint from the requesting body or on its own initiative, shall implement the procedures provided for by Community law.
Article 5
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1991. They shall forthwith inform the Commission thereof.
Article 6
This Directive is addressed to the Member States. | [
"UKPGA19890029",
"UKPGA19760076"
] |
31990L0628 | 1990 | Commission Directive 90/628/EEC of 30 October 1990 adapting to technical progress Council Directive 77/541/EEC on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 77/541/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (1), as last amended by the Act of Accession of Spain and Portugal, and in particular Article 10 thereof,
Whereas a comprehensive evaluation of Directive 77/541/EEC has shown that it is possible to improve road safety further by applying practical experience and technological development and taking into account the progress made in the Economic Community for Europe of the United Nations, notably in Regulation No 16, by
- inserting requirements for type-approval of 'harness belts` for special vehicle types,
- inserting requirements for type-approval of safety belts with preloaders,
- specifying installation of appropriate safety belts for all seating positions in all motor vehicle categories with minimal exemptions as necessary,
- introducing a model for a document certifying the actual installation of safety belts in a specific vehicle type to be approved,
- introducing test requirements for height adjustment devices for belts,
and
- introducing more stringent requirements on the conformity of production;
Whereas that experience shows that some existing definitions and requirements have to be adjusted slightly;
Whereas the protection of passengers, especially of passengers in buses and coaches, against ejection in case of an accident must be improved and further modifications to the Directive should be introduced for this purpose;
Whereas everything should be done in order that these modifications can be applied by 31 December 1991 at the latest;
Whereas the adoption of a Directive on the mandatory wearing of safety belts for all occupants of vehicles of less then 3,5 tonnes should be linked to a further modification of the Directive aiming to render mandatory the installation of three-point belts with retractors also for the rear outboard seats of such vehicles;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the removal of technical barriers to trade in motor vehicles,
Article 1
The Annexes to Directive 77/541/EEC are hereby amended in accordance with the Annex to this Directive.
Article 2
1. With effect from 1 May 1991 no Member State may
(a) on grounds relating to safety belts or restraint systems:
- refuse, in respect of a type of vehicle, to grant EEC type-approval, or to issue the copy of the certificate provided for in the last indent of Article 10 (1) of Council Directive 70/156/EEC (1), or to grant national type-approval, or
- prohibit the entry into service of vehicles
if the safety belts or restraint systems of this type of vehicle or of these vehicles have been approved in accordance with Directive 77/541/EEC, as amended by this Directive;
(b)
- refuse to grant EEC component type-approval in respect of a type of safety belt or restraint system, intended for installation in a vehicle, which complies with the requirements of Directive 77/541/EEC, as amended by this Directive,
- prohibit the placing on the market of such safety belts and restraint systems which bear the EEC component type-approval marks prescribed in this Directive.
2. With effect from 1 July 1992 Member States:
(a)
- shall no longer issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle,
- may refuse to grant national type-approval in respect of a type of vehicle,
of which the safety belts or restraint systems have not been approved in accordance with Directive 77/541/EEC, as amended by this Directive;
(b)
- may refuse to grant EEC component type-approval in respect of a type of safety belt or restraint system, intended for installation in a vehicle, which does
not comply with the requirements of Directive 77/541/EEC, as amended by this Directive.
3. With effect from 1 July 1997 Member States:
- may prohibit the entry into service of vehicles of which the safety belts or restraint system have not been approved in accordance with Directive 77/541/EEC, as amended by this Directive,
- may prohibit the placing on the market of safety belts and restraint systems, intended for installation in a vehicle, which do not bear the EEC component type-approval marks prescribed in the Directive.
Article 3
Member States shall implement the provisions necessary to comply with this Directive before 1 May 1991. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19910820",
"UKSI19912003"
] |
31990L0629 | 1990 | Commission Directive 90/629/EEC of 30 October 1990 adapting to technical progress Council Directive 76/115/EEC on the approximation of the laws of the Member States relating to anchorages for motor vehicle safety belts
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 76/115/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts (1), as last amended by Commission Directive 82/318/EEC (2), and in particular Article 6 thereof,
Whereas practical experience and technological development show that it is possible to improve road safety by applying similar requirements to those existing already to vehicle categories M2 with a permissible maximum mass exceeding 3 500 kilograms and M3 (buses) which were not covered hitherto and to generally extend the requirements to
seating positions, not covered hitherto, of other vehicle categories;
Whereas that experience shows that some existing definitions and requirements have to be adjusted slightly;
Whereas the protection against "submarining'' should be improved, which could be provided by modified positioning of the anchorages for safety belts and/or modifications to
the seat construction; whereas a test procedure must be developed which enables the improvement in the level of protection to be shown;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the removal of technical barriers to trade in motor vehicles,
Article 1
Annex I to Directive 76/115/EEC, is hereby amended in accordance with the Annex to this Directive.
Article 2
1. With effect from 1 May 1991 no Member State may, on grounds relating to anchorages for safety belts:
- refuse, in respect of a type of vehicle, to grant EEC type-approval, or to issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC (3), or to grant national type-
approval, or
- prohibit the entry into service of vehicles
if the anchorages in this type of vehicle or in these vehicles comply with the requirements of Directive 76/115/EEC, as amended by this Directive.
2. With effect from 1 July 1992 Member States:
- shall no longer issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle,
- may refuse to grant national type-approval in respect of a type of vehicle
in which the anchorages do not comply with the requirements of Directive 76/115/EEC, as amended by this Directive.
3. With effect from 1 July 1997 Member States may prohibit the entry into service of vehicles in which the anchorages do not comply with the requirements of Directive 76/115/EEC, as amended by this Directive.
Article 3
The Commission shall, not later than 31 December 1992, proceed to a further review of the provisions of Directive 76/115/EEC and notably Annex I, item 4.4.3 thereof,
in order to improve the protection against the risk
of submarining, which amendment might include new measures and related dynamic test methods.
Article 4
Member States shall implement the provisions necessary in order to comply with this Directive before 1 May 1991. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 5
This Directive is addressed to the Member States. | [
"UKSI19910820",
"UKSI19912003"
] |
31990L0630 | 1990 | Commission Directive 90/630/EEC of 30 October 1990 adapting to technical progress Council Directive 77/649/EEC on the approximation of the laws of the Member States relating to the field of vision of motor vehicle drivers
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 77/649/EEC of
27 September 1977 on the approximation of the laws of
the Member States relating to the field of vision of motor vehicles (1), as last amended by Commission Directive 88/366/EEC (2), and in particular Article 5 thereof,
Whereas, in view of experience gained and of the state of the art, it is now appropriate to render more precise the test procedure laid down in Annex III to Directive 77/649/EEC, and in particular, to align it to the latest developments in the United Nations Economic Commission for Europe;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the removal of technical barriers to trade in motor vehicles,
Article 1
Annex III to Directive 77/649/EEC is hereby amended in accordance with the Annex to this Directive.
Article 2
1. With effect from 1 May 1991 no Member State may, on grounds relating to field of vision:
- refuse, in respect of a type of vehicle, to grant EEC type-approval, or to issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC (3), or to grant national type-
approval, or
- prohibit the entry into service of vehicles
where the field of vision of drivers of such type of vehicle or of such vehicles has been determined in accordance with Directive 77/649/EEC, as amended by this Directive.
2. With effect from 1 October 1991 Member States:
- shall no longer issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle of which the driver's field of vision has not been determined in accordance with Directive 77/649/EEC, as amended by this Directive,
- may refuse to grant national type-approval of a type of vehicle of which the driver's field of vision has not been determined in accordance with Directive 77/649/EEC, as amended by this Directive.
Article 3
Member States shall implement the provisions necessary in order to comply with this Directive before 1 May 1991. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19910820",
"UKSI19912003"
] |
31990L0619 | 1990 | Council Directive 90/619/EEC of 8 November 1990 on the coordination of laws, regulations and administrative provisions relating to direct life assurance, laying down provisions to facilitate the effective exercise of freedom to provide services and amending Directive 79/267/EEC
Having regard to the Treaty establishing the European Economic Community, and in particular Articles 57 ( 2 ) and 66 thereof,
Having regard to the proposal from the Commission ( 1 ),
In cooperation with the European Parliament ( 2 ),
Having regard to the opinion of the Economic and Social Committee ( 3 ),
Whereas it is necessary to develop the internal market in life assurance and in the operations referred to in First Council Directive 79/267/EEC of 5 March 1979 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct life assurance ( 4 ), hereinafter called the "First Directive' as last amended by the Act of Accession of Spain and Portugal; whereas, in order to achieve that objective, it is desirable to make it easier for assurance undertakings having their head office in the Community to provide services in the Member States, thus making it possible for policy-holders to have recourse not only to assurers established in their own country, but also to assurers which have their head office in the Community and are established in other Member States;
Whereas, under the Treaty, any discrimination with regard to freedom to provide services based on the fact that an undertaking is not established in the Member State in which the services are provided has been prohibited since the end of the transitional period; whereas that prohibition applies to services provided from any establishment in the Community, whether it be the head office of an undertaking or an agency or branch;
Whereas, for practical reasons, it is desirable to define provision of services taking into account both the assurer's establishment and the place where the commitment is to be covered; whereas, therefore, commitment should also be defined; whereas, moreover, it is desirable to distinguish between activities pursued by way of establishment and activities pursued by way of freedom to provide services;
Whereas it is desirable to supplement the First Council Directive in order in particular to clarify the powers and means of supervision vested in the supervisory authorities; whereas it is also desirable to lay down specific provisions regarding the taking-up, pursuit and supervision of activity by way of freedom to provide services;
Whereas policy-holders who, by virtue of the fact that they take the initiative in entering into a commitment in another State and thus place themselves under the protection of the legal system of that other State, do not require special protection in the State of the commitment, should be granted complete freedom to avail themselves of the widest possible market in life assurance and in the operations referred to in the First Directive; whereas other policy-holders should also be afforded adequate protection;
Whereas in the management of some group pension funds, the multiplicity and complexity of the various schemes and their close connection with social security schemes call for careful study; whereas they should therefore be excluded from the scope of the provisions specific to freedom to provide services contained in this Directive; whereas they will form the subject matter of another Directive;
Whereas the provisions in force in the Member States regarding contract law applicable to the activities referred to in the First Directive continue to differ; whereas the freedom to choose, as the law applicable to the contract, a law other than that of the State of the commitment may be granted in certain cases, in accordance with rules which take into account specific circumstances;
Whereas the First Directive's provisions on transfer of portfolio should be reinforced and supplemented by provisions specifically concerning the transfer to another undertaking of the portfolio o
contracts concluded by way of freedom to provide services;
Whereas, in the interests of protecting policy-holders, Member States should, at the present stage of the coordination process, be given the option of limiting the simul
taneous pursuit of activity by way of freedom to provide services and activity by way of establishment; whereas no such limitation can be provided for where policy-holders do not require such protection;
Whereas the taking-up and pursuit of activity by way of freedom to provide services should be subject to procedures guaranteeing the assurance undertaking's compliance with provisions regarding financial guarantees, conditions of assurance and premium rates; whereas those procedures may be relaxed where the activity pursued by way of freedom to provide services covers policy-holders who, by virtue of the characteristics of the commitment they propose to enter into, do not require special protection in the State of the commitment;
Whereas for life assurance contracts entered into by way of the free provision of services the policy-holder should be given the opportunity of cancelling the contract within a period of between 14 and 30 days;
Whereas the First Directive adopted the principle of prohibiting the simultaneous pursuit of the activities covered by Directive 73/239/EEC ( 1 ) ( called the First Directive on the coordination of non-life insurance ) as last amended by Directive 88/357/EEC ( 2 ) and those covered by the First Directive; whereas, while it authorized the continued existence of existing composite undertakings, it stated that they may not set up agencies or branches for life assurance; whereas the specific nature of the commitments entered into in the insurance field under the freedom of services regime nevertheless justifies, at least on a transitional basis as from notification of this Directive to Member States, the introduction of a degree of flexibility in the application of the above principle;
Whereas nothing in this Directive would prevent a composite undertaking from dividing itself into two undertakings, one active in the field of life assurance, the other in non-life insurance; whereas in order to allow such division to take place under the best possible conditions, it is desirable to permit Member States, in accordance with Community rules of competition law, to provide for appropriate tax arrangements, in particular with regard to the capital gains such division could entail;
Whereas it is necessary to make provision for special cooperation in the sphere of freedom to provide services between the competent supervisory authorities of the Member States and between those authorities and the Commission; whereas provision should also be made for a system of penalties to apply where the undertaking providing the service fails to comply with the provisions of the Member State in which the service is provided;
Whereas the technical reserves, including mathematical reserves, should be subject to the rules of and supervision by the Member State in which the service is provided where the provision of services involves commitments in respect of which the State in which the service is received wishes to provide special protection for policy-holders; whereas, however, if such concern to protect policy-holders is unjustified, the technical reserves, including mathematical reserves, should remain subject to the rules of and supervision by the Member State in which the undertaking is established;
Whereas some Member States do not subject life assurance contracts and the other operations covered by the First Directive to any form of indirect taxation, while others apply special taxes; whereas the structure and rate of those taxes vary considerably between the Member States in which they are applied; whereas it is desirable to avoid a situation where those differences lead to distortions of competition between undertakings in the various Member States; whereas, pending further harmonization, the application of the tax arrangements provided for by the Member State in which the commitment is entered
into is a means of remedying such mischief; whereas it is for the Member States to establish a method of ensuring that such taxes are collected;
Whereas the First Directive makes express provision for specific rules concerning the authorization of agencies and branches of undertakings whose head offices are outside the Community;
Whereas provision should be made for a flexible procedure to make it possible to assess reciprocity with third countries on a Community basis; whereas the aim of this procedure is not to close the Community's financial markets but rather, as the Community intends to keep its financial markets open to the rest of the world, to improve the liberalization of the global financial markets in other third countries; whereas, to that end, this Directive provides for procedures for negotiating with third countries and, as a last resort, for the possibility of taking measures involving the suspension of new applications for authorization or the restriction of new authorizations;
Whereas it is desirable to take into account, within the meaning of Article 8c of the Treaty, the extent of the effort which needs to be made by certain economies showing differences in development; whereas, therefore, it is desirable to grant certain Member States transitional arrangements for the gradual application of the specific provisions of this Directive relating to freedom to provide services;
Whereas, in view of the differences in the national legislations, it is also appropriate to grant to those Member States which so wish transitional arrangements enabling them to adapt their legislation before applying in their entirety, as regards group insurance contracts linked to a contract of employment or the intervention of a broker, the provisions of this Directive relating to the case where the policy-holder takes the initiative to conclude a contract by way of provision of services;
Whereas it will be particularly important to allow those Member States who so wish a sufficiently long period to be able to adopt the appropriate provisions in order to ensure the professional qualification and independence of insurance brokers; whereas taking into account the growing role such brokers play in advising those buying insurance and facing an increasing range of products as a result of the freedom to provide services, their professional qualification and independence will become essential elements for protection of the consumer,
TITLE I
General provisions
Article 1
The object of this Directive is to :
( a ) supplement Directive 79/267/EEC;
( b ) lay down specific provisions relating to freedom to provide services in respect of the activities referred to in the said Directive, such provisions being set forth in Title III of this Directive .
Article 2
For the purposes of this Directive :
( a ) "First Directive ': means Directive 79/267/EEC;
( b ) "undertaking ':
_ for the purposes of Titles I and II, means any undertaking which has received official authorization under Article 6 or Article 27 of the First Directive,
_ for the purposes of Titles III and IV, means any undertaking which has received official authorization under Article 6 of the First Directive;
( c ) "establishment ':
means the head office, an agency or a branch of an undertaking, having regard to Article 3;
( d ) "commitment ':
means a commitment represented by one of the kinds of insurance or operation referred to in Article 1 of the First Directive;
( e ) "Member State of the commitment ':
means the Member State where the policy-holder has his habitual residence or, if the policy-holder is a legal person, the Member State where the latter's establishment, to which the contract relates is situated;
( f ) "Member State of establishment ':
means the Member State in which the establishment covering the commitment is situated;
( g ) "Member State of provision of services ':
means the Member State of the commitment where the commitment is covered by an establishment situated in another Member State;
( h ) "parent undertaking ':
means a parent undertaking within the meaning of Articles 1 and 2 of Directive 83/349/EEC ( 1 );
( i ) "subsidiary ':
means a subsidiary undertaking within the meaning of Articles 1 and 2 of Directive 83/349/EEC; any subsidiary undertaking of a subsidiary undertaking shall also be regarded as a subsidiary of the parent undertaking which is at the head of those undertakings .
Article 3
For the purposes of the First Directive and of this Directive, any permanent presence of an undertaking in the territory of a Member State shall be treated in the same way as an agency or branch, even if that presence does not take the form of a branch or agency, but consists merely of an office managed by the undertaking's own staff or by a person who is independent but has permanent authority to act for the undertaking as an agency would .
TITLE II
Provisions supplementary to the First Directive
Article 4
1 . The law applicable to contracts relating to the activities referred to in the First Directive shall be the law of the Member State of the commitment . However, where the law of that State so
allows, the parties may choose the law of another country .
2 . Where the policy-holder is a natural person and has his habitual residence in a Member State other than that of which he is a national, the parties may choose the law of the Member State of which he is a national .
3 . Where a State includes several territorial units, each of which has its own rules of law concerning contractual obligations, each unit shall be considered a country for the purposes of identifying the law applicable under this Directive .
( 1 ) OJ No C 38 of 15 . 2 . 1989, p . 7 and
OJ No C 72 of 22 . 3 . 1990, p . 5 .
( 2 ) OJ No C 175, 16 . 7 . 1990, p . 107, and Decision of 24 October 1990 ( not yet published in the Official Journal ).
( 3 ) OJ No C 298, 27 . 11 . 1989, p . 2 .
( 4 ) OJ No L 63, 13 . 3 . 1979, p . 1 .
( 1 ) OJ No L 228, 16 . 8 . 1973, p . 3 .
( 2 ) OJ No L 172, 4 . 7 . 1988, p . 1 .
( 1 ) OJ No L 193, 18 . 7 . 1983, p . 1 .
A Member State in which various territorial units have their own rules of law concerning contractual obligations shall not be bound to apply the provisions of this Directive to conflicts which arise between the laws of those units .
4 . Nothing in this Article shall restrict the application of the rules of the law of the forum in a situation where they are mandatory, irrespective of the law otherwise applicable to the contract .
If the law of a Member State so stipulates, the mandatory rules of the law of the Member State of the commitment may be applied if and in so far as, under the law of that Member State, those rules must be applied whatever the law applicable to the contract .
5 . Subject to the preceding paragraphs, the Member States shall apply to the assurance contracts referred to in this Directive their general rules of private international law concerning contractual obligations .
Article 5
The following paragraph is added to Article 23 of the First Directive :
"3 . Each Member State shall take all steps necessary to ensure that the authorities responsible for supervising assurance undertakings have the powers and means necessary for supervision of the activities of assurance undertakings established within their territory, including activities engaged in outside that territory, in accordance with the Council Directives governing those activities and for the purpose of ensuring that they are implemented .
Those powers and meanst must, in particular, enable the supervisory authorities to :
_ make detailed inquires about the undertaking's situation and the whole of its business, inter alia by :
_ gathering information or requiring the submission of documents concerning assurance business,
_ carrying out on-the-spot investigations at the undertaking's premises,
_ take any measures, with regard to the undertaking, which are appropriate and necessary to ensure that the activities of the undertaking remain in conformity with the laws, regulations and administrative provisions with which the undertaking has to comply in each Member State and in particular with the scheme of operations insofar as it remains mandatory, and to prevent or remove any irregularities prejudicial to the interests of policy-holders,
_ ensure that measures required by the supervisory authorities are carried out, if need be by enforcement, where appropriate through judicial channels .
Member States may also make provision for the supervisory authorities to obtain any information regarding contracts which is held by intermediaries .'
Article 6
1 . Article 25 of the First Directive is hereby deleted .
2 . Each Member State shall, under the conditions laid down by national law, authorize undertakings which are established within its territory to transfer all or part of their portfolios of contracts for which that State is the State of the commitment, to an accepting office establishing in that same Member State if the supervisory authorities of the Member State in which the head office of the accepting office is situated certify that the latter possesses the necessary margin of solvency after taking the transfer into account .
3 . Each Member State shall, under the conditions laid down by national law, authorize undertakings established within its territory to transfer all or part of their portfolios of contracts concluded in the circumstances referred to in Article 10 ( 1 ) to an accepting office established in the Member State of provision of services if the supervisory authorities of the Member State in which the head office of the accepting office is situated certify that the latter possesses the necessary margin of solvency after taking the transfer into account .
4 . Each Member State shall, under the conditions lai
down by national law, authorize undertakings established within its territory to transfer all or part of their portfolios of contracts conluded in the circumstances referred to in Article 10 ( 1 ) to an accepting office established in the same Member State if the supervisory authorities of the Member State in which the head office of the accepting office is situated certify that the accepting office possesses the necessary margin of solvency after taking the transfer into account and if it fulfils the conditions set out in Articles 11, 12, 14 and 16 in the Member State of provision of services .
5 . In the cases referred to in paragraphs 3 and 4, the supervisory authorities of the Member State in which the transferring undertaking is established shall authorize the transfer after obtaining the agreement of the supervisory authorities of the Member State of provision of services .
6 . If a Member State, under the conditions laid down by national law, authorizes undertakings established within its territory to transfer all or part of their portfolios of contracts to an accepting office established in another
Member State which is not the Member State of provision of services, it shall ensure that the following conditions are fulfilled :
_ the supervisory authorities of the Member State in which the head office of the accepting office is situated certify that the latter possesses the necessary margin of solvency after taking the transfer into account,
_ the Member State in which the accepting office is established agrees,
_ the accepting office fulfils the conditions set out in Articles 11, 12, 14 and 16 in the Member State of provision of services, the law of that Member State provides for the possibility of such a transfer and that Member State agrees to the transfer .
7 . A transfer authorized in accordance with this Article shall be published, under the conditions laid down by national law, in the Member State of the commitment . Such transfer shall be automatically valid against policy-holders, assured persons and any other person having rights or obligations arising out of the contracts transferred .
This provision shall not affect the right of Member States to provide that policy-holders may cancel the contract within a given period after the transfer .
Article 7
Article 22 ( 2 ) of the First Directive is replaced by the following :
"2 . The Italian Republic shall take all steps to ensure that the requirement that undertakings established in its territory cede part of their underwriting to the "Istituto Nazionale di Assicurazioni" is abolished no later than 20 November 1994 .'
Article 8
1 . The heading of Title III of the First Directive is replaced by the following :
"TITLE III A
Rules applicable to agencies or branches established within the Community and belonging to undertakings whose head offices are outside the Community'
2 . The following heading is placed after Article 32 of the First Directive :
"TITLE III B
Rules applicable to subsidiaries of parent undertakings governed by the laws of a third country and to acquisitions of holdings by such parent undertakings '.
Article 9
The following Articles are added to Title III B of the First Directive :
"Article 32a
The competent authorities of the Member States shall inform the Commission :
( a ) of any authorization of a direct of indirect subsidiary one or more parent undertakings of which are governed by the laws of a third country . The Commission shall inform the Committee referred to in Article 32b ( 6 ) accordingly;
( b ) whenever such a parent undertaking acquires a holding in a Community insurance undertaking which would turn the latter into its subsidiary . The Commission shall inform the Committee referred to in Article 32b ( 6 ) accordingly .
When authorization is granted to the direct or indirect subsidiary of one or more parent undertakings governed by the law of third countries, the structure of the groupe shall be specified in the notification which the competent authorities shall address to the Commission .
Article 32b
1 . The Member States shall inform the Commission of any general difficulties encountered by their insurance undertakings in establishing themselves or carrying on their activities in a third country .
2 . Initially no later than six months before the date referred to in the second paragraph of Article 30 of Directive 90/619/EEC ( 1 ), and thereafter periodically, the Commission shall draw up a report examining the treatment accorded to Community insurance undertakings in third countries, in the terms referred to in paragraphs 3 and 4, as regards establishment and the carrying on of insurance activities, and the acquisition of holdings in third-country insurance undertakings . The Commission shall submit those reports to the Council, together with any appropriate proposals .
3 . Whenever it appears to t
Commission, either on the basis of the reports referred to in paragraph 2 or on the basis of other information, that a third country is not granting Community insurance undertakings effective market access comparable to that granting Community to insurance undertakings effective market access comparable to that granted by the Community to insurance undertakings from that third country, the Commission may submit proposals to the Council for the appropriate mandate for negotiation with a view to obtaining comparable competitive opportunities for Community insurance undertakings . The Council shall decide by a qualified majority .
4 . Whenever it appears to the Commission, either on the basis of the reports referred to in paragraph 2 or on the basis of other information, that Community insurance undertakings in a third country are not
receiving national treatment offering the same competitive opportunities as are available to domestic insurance undertakings and that the conditions of effective market access are not being fulfilled, the Commission may initiate negotiations in order to remedy the situation .
In the circumstances described in the first subparagraph, it may also be decided at any time, and in addition to initiating negociations, in accordance with the procedure laid down in Article 32b ( 6 ), that the competent authorities of the Member States must limit or suspend their decisions :
_ regarding requests pending at the moment of the decision or future requests for authorizations, and
_ regarding the acquisition of holdings by direct or indirect parent undertakings governed by the laws of the third country in question .
The duration of the measures referred to may not exceed three months .
Before the end of that three-month period, and in the light of the results of the negotiations, the Council may, acting on a proposal from the Commission, decide by a qualified majority whether the measures shall be continued .
Such limitations or suspension may not apply to the setting up of subsidiaries by insurance undertakings or their subsidiaries duly authorized in the Community, or to the acquisition of holdings in Community insurance undertakings by such undertakings or subsidiaries .
5 . Whenever it appears to the Commission that one of the situations described in paragraphs 3 and 4 has arisen, the Member States shall inform it at its request :
( a ) of any request for the authorization of a direct or indirect subsidiary one or more parent undertakings of which are governed by the laws of the third country in question;
( b ) of any plans for such an undertaking to acquire a holding in a Community insurance undertaking such that the latter would become the subsidiary of the former .
This obligation to provide information shall lapse whenever an agreement is reached with the third country referred to in paragraph 3 or 4 when the measures referred to in the second and third subparagraphs of paragraph 4 cease to apply .
6 . The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission .
The representative of the Commission shall submit to the committee a draft of the measures to be taken . The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter . The opinion shall be delivered by the majority laid down in Article 148 ( 2 ) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission . The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article . The chairman shall not vote .
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee .
If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken . The Council shall act by a qualified majority .
If, on the expiry of a period to be laid down in each act to be adopted by the Council under this paragraph but which may in no case exceed three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority .
7 . Measures taken under this Article shall comply with the Community's obligations under any international agreements, bilateral or multilateral, governing the taking-up and pursuit of the busin
of insurance undertakings .
( 1 ) OJ No L 330, 29 . 11 . 1990, p . 50 .'
TITLE III
Provisions relating specifically to the freedom to provide services
Article 10
1 . This Title shall apply where an undertaking, through an establishment situated in a Member State, covers a commitment in another Member State .
2 . This Title shall apply to :
_ the types of insurance referred to in Article 1 ( 1 ) of the First Directive,
_ the operations referred to in Article 1 ( 2 ) ( a ) and ( b ) of the First Directive .
3 . This Title shall not apply to the operations and bodies referred to in Article 1 ( 2 ) ( c ), ( d ) and ( e ), Article 1 ( 3 ) and Articles 2, 3 and 4 of the First Directive .
4 . An undertaking shall not cover a commitment in another Member State unless it is authorized under Article 6 of the First Directive to cover such a commitment in its Member State of establishment .
Article 11
Any undertaking which intends to provide services shall first inform the competent authorities of the head office Member State, and, where appropriate, of the Member State of the establishment concerned, indicating the Member State or Member States within whose territory it intends to provide services and the nature of the commitments it proposes to cover .
Article 12
1 . Subject to Article 13, each Member State within whose territory an undertaking intends, by way of freedom to provide services, to cover commitments within the meaning of Article 10 may make the taking-up of such activity conditional on official authorization insofar as the commitments are not entered into in accordance with the arrangements referred to in Article 13; to that end, it may require that the undertaking :
( a ) produce a certificate issued by the competent authorities of the head office Member State certifying that it possesses for its activities as a whole the minimum solvency margin calculated in accordance with Article 19 of the First Directive and that, in accordance with Article 6 ( 1 ) of the said Directive, the authorization enables the undertaking to operate outside the Member State of establishment;
( b ) produce a certificate issued by the competent authorities of the Member State of establishment indicating the classes in respect of which the undertaking is authorized to transact business and certifying that those authorities do not object to the undertaking's transacting business by way of freedom to provide services;
( c ) submit a scheme of operations concerning the following particulars :
_ the nature of the commitments which the undertaking proposes to cover in the Member State of provision of services,
_ the general and special conditions of the assurance policies which it proposes to use there,
_ the premium rates which the undertaking envisages applying and the technical bases which it proposes to use for each class of business,
_ the forms and other printed documents which it intends to use in its dealings with policy-holders, insofar as these are also required of established undertakings .
2 . The competent authorities of the Member State of provision of services may require that the particulars referred to in paragraph 1 ( c ) be supplied to them in the official language of that State .
3 . The competent authorities of the Member State of provision of services shall have a period of six months from receipt of the documents referred to in paragraph 1 in which to grant or refuse authorization on the basis of the compliance or non-compliance of the particulars in the scheme of operations submitted by the undertaking with the laws, regulations and administrative provisions applicable in that State .
Such authorization may not be refused on the grounds that some operations in the scheme of operations, which are subject in the Member State of establishment of the undertaking to supervision by the authorities responsible for the supervision of insurance undertakings, are not subject to such supervision in the Member State of provision of services .
4 . If the competent authorities of the Member State of provision of services have not taken a decision by the end of the period referred to in paragraph 3, authorization shall be deemed to be refused .
5 . Any decision to refuse authorization or to refuse a certificate as refer
to in paragraph 1 ( a ) or ( b ) shall be accompanied by the precise grounds therefor and communicated to the undertaking in question .
6 . Each Member State shall make provision for the right to apply to the courts in respect of a refusal of authorization or refusal to issue the certificate referred to in paragraph 1 ( a ) or ( b ).
Article 13
1 . Commitments covered by way of freedom to provide services shall be subject to Article 14 where the policy-holder takes the initiative in seeking a commitment from the undertaking .
The policy-holder shall be deemed to have taken the initiative :
_ where, on the one hand, the contract is entered into by both parties in the Member State in which the undertaking is established or by each of the parties in that party's own State of establishment or of habitual residence, and where, on the other hand, the policy-holder has not been contacted in his State of habitual residence by the undertaking or through an insurance intermediary or any person authorized to act for it or by means of any solicitation of business addressed to him personally,
_ where the policy-holder approaches an intermediary established in the Member State in which the policy-holder has his habitual residence and carrying on the professional activities defined in Article 2 ( 1 ) ( a ) of Directive 77/92/EEC ( 1 ), in order to obtain information on assurance contracts offered by undertakings established in Member States other than his State of habitual residence or with a view to entering into a commitment through the intermediary with such an undertaking . In that event the policy-holder shall sign a statement, the text of which is set out, under item A in the Annex, expressly so requesting .
2 . Before entering into a commitment in the cases referred to in the first and second indents of paragraph 1, the policy-holder shall sign a statement, the text of which is set out under item B in the Annex, to the effect that he notes that the commitment is subject to the rules of supervision of the Member State of establishment which is to cover the commitment .
Article 14
1 . Each Member State within whose territory an undertaking intends, by way of freedom to provide services, to cover commitments in accordance with Article 13 shall require that the undertaking abide by the following procedure :
( a ) production of a certificate issued by the competent authorities of the head office Member State certifying that it possesses for its activities as a whole the minimum solvency margin calculated in accordance with Article 19 of the First Directive and that, in accordance with Article 6 ( 1 ) of the said Directive, the authorization enables the undertaking to operate outside the Member State of establishment;
( b ) production of a certificate issued by the competent authorities of the Member State of establishment indicating the classes in respect of which the undertaking is authorized to transact business and certifying that those authorities do not object to the undertaking's transacting business by way of freedom to provide services;
( c ) statement of the nature of the commitments which it proposes to cover in the Member State of provision of services .
The above procedure shall not apply where an activity falling within this Directive is not subject, in the Member State of the commitment, to supervision by the administrative authorities responsible for supervising private insurance .
2 . Each Member State shall make provision for the right to apply to the courts in respect of a refusal to issue the certificate referred to in paragraph 1 ( a ) or ( b ).
3 . The undertaking may commence activities as from the certified date on which the authorities of the Member State of provision of services are in possession of the documents referred to in paragraph 1 .
4 . This Article shall also apply where the Member State in whose territory an undertaking intends, by way of freedom to provide services, to cover commitments in accordance with arrangements other than those referred to in Article 13 of this Directive does not make the taking-up of such activity conditional on official authorization .
5 . Member States may not prevent the policy-holder from entering into any commitment which may be lawfully undertaken in the Member State of establishment unless it is contrary to public policy in the Member State of the commitment .
Article 15
1 . Each Member State shall prescribe that a policy-holder who concludes an individual life-assurance contract in one of the cases referred to in Title III shall have a period of between 14 and 30 days from the time when he was informed that the contract had been concluded within which to cancel the contract .
The giving of notice of cancellation by the policy-holder shall have the effect of releasing him from any future obligation arising from the contract .
The othe
legal effects and the conditions of cancellation shall be determined by the law applicable to the contract as defined in Article 4, notably as regards the arrangements for informing the policy-holder that the contract has been concluded .
2 . The Member States need not apply paragraph 1 to contracts of six months' duration or less .
Article 16
Member States' legislation shall provide that an undertaking established in a Member State may cover within that State by way of freedom to provide services from an establishment in another Member State at least :
_ the commitments within the meaning of Article 10, where they are entered into in accordance with the arrangements in Article 13,
_ the commitments within the meaning of Article 10 entered into in accordance with arrangements other than those laid down in Article 13, where they fall within classes in respect of which the undertaking established in the first Member State lacks authorization there in accordance with Article 6 of the First Directive .
If, however, in the latter case that undertaking has such authorization, the first Member State may prevent such provision of services .
Article 17
1 . Where an undertaking referred to in Article 11 intends to amend the information referred to in Article 12 ( 1 ) ( c ) or 14 ( 1 ) ( c ), it shall submit the amendments to the competent authorities of the Member State of provision of services . Those amendments shall be subject to the provisions of Article 12 ( 3 ) and 14 ( 3 ), as the case may be .
2 . Where the undertaking intends to extend its activities to commitments within the meaning of Article 10 in accordance with arrangements other than those laid down in Article 13 or 14 ( 4 ), it shall follow the procedure laid down in Articles 11 and 12 .
3 . Where the undertaking intends to extend its activities to commitments in accordance with the arrangements laid down in Article 13 or 14 ( 4 ), it shall follow the procedure laid down in Articles 11 and 14 .
Article 18
1 . Undertakings which, by virtue of Article 13 ( 3 ) of the First Directive, carry on simultaneously the activities referred to in the Annex to Directive 73/239/EEC and those listed in Article 1 of the First Directive may accept commitments in any of the classes referred to in the First Directive by way of provision of services as referred to in Article 13 of this Directive . They may also accept commitments by way of provision of services as referred to in Article 12 if the law of the Member State of provision of services so allows at the time of notification of this Directive, or thereafter and until 31 December 1995 in the other Member States .
2 . This Article will be reviewed in the light of the report to be prepared by the Commission in accordance with Article 39 ( 2 ) of the First Directive .
Article 19
1 . Member States of provision of services may maintain or introduce laws, regulations or administrative provisions justified on policy-holder protection grounds, concerning, in particular, approval of general and special policy conditions, of forms and other printed documents for use in dealings with policy-holders, of scales of premiums and of any other document necessary for the normal exercise of supervision on condition that the rules of the Member State of establishment are insufficient to achieve the necessary level of protection and the requirements of the Member State of provision of services do not go beyond what is necessary in that respect .
2 . However, with regard to commitments entered into in accordance with the arrangements described in Article 13, Member States of provision of services shall not lay down provisions requiring approval or notification of general and special policy conditions, scales of premiums, forms and other printed documents which the undertaking intends to use in its dealings with policy-holders .
3 . They may require only non-systematic notification of these conditions and other documents, for the purpose of verifying compliance with laws, regulations and administrative provisions in respect of such commitments, although this requirement may not constitute a prior condition in order for an undertaking to carry on its activities .
Article 20
1 . Any undertaking providing services shall submit to the competent authorities of the Member State of provision of services all documents requested of it for the purposes of implementing this Article, insofar as undertakings established there are also obliged to do so .
2 . If the competent authorities of a Member State establish that an undertaking providing services within its territory does not comply with the legal provisions applicable to it in that State, such authorities shall request the undertaking concerned to put an end to the irregular situation .
3 . If the undertaking in question fails to comply with the request referred to in paragraph 2, the competent authorities of the Membe
State of provision of services shall inform the competent authorities of the Member State of establishment accordingly . The latter authorities shall take all appropriate steps to ensure that the undertaking concerned puts an end to that irregular situation . The nature of those measures shall be communicated to the authorities of the Member State of provision of services .
The competent authorities of the Member State of provision of services may also apply to the competent authorities responsible for the head office of the assurance undertaking if the services are being provided by agencies or branches .
4 . If, despite the steps thus taken by the Member State of establishment, or because such steps prove inadequate or are lacking in the Member State in question, the undertaking persists in violating the legal provisions in force in the Member State of provision of services, the latter Member State may, after informing the supervisory authorities of the Member State of establishment, take appropriate steps to prevent further irregularities, including, insofar as it is strictly necessary, the prevention of the further covering of commitments by the undertaking by way of freedom to provide services within its territory . In the case of commitments covered by way of freedom to provide services in accordance with arrangements other than those referred to in Article 13 of this Directive, such steps shall include withdrawal of the authorization referred to in Article 12 . Member States shall ensure that within their territory it is possible to effect the notifications necessary for such steps .
( 1 ) OJ No L 26, 31 . 1 . 1977, p . 14 .
5 . These provisions shall not affect the right of Member States to punish irregularities committed within their territory .
6 . If the undertaking which has committed the irregularity has an establishment or owns property in the Member State of provision of services, the supervisory authorities of the latter may, in accordance with national law, apply the administrative penalties prescribed for such irregularity by way of enforcement against such establishment or property .
7 . Any step taken under paragraphs 2 to 6 involving penalties or restrictions on the provision of services must be properly justified and communicated to the undertaking concerned . Every such measure shall be subject to the right to apply to the courts in the Member State in which the authorities adopted it .
8 . Where steps are taken under Article 24 of the First Directive, the competent authorities of the Member State of provision of services shall be informed accordingly by the authority which takes them and, where the steps are taken under paragraphs 1 and 3 of the said Article, take whatever action is necessary to safeguard the interests of assured persons .
In the event of withdrawal of authorization under Article 26 of the First Directive, the competent authorities of the Member State of provision of services shall be informed accordingly and shall take appropriate steps to prevent the establishment concerned from continuing to conclude assurance contracts by way of freedom to provide services within the territory of that Member State .
9 . Every two years the Commission shall submit to the Council a report summarizing the number and type of cases in which, in each Member State, decisions refusing authorization have been communicated under Article 12 or measures have been taken under paragraph 4 . Member States shall cooperate with the Commission by providing it with the information required for the report .
Article 21
In the event of an assurance undertaking being wound up, commitments arising from contracts underwritten by way of freedom to provide services shall be met in the same way as those arising from that undertaking's other assurance contracts, no distinction being made on grounds of the nationality of assured persons or beneficiaries .
Article 22
1 . Where an operation is offered by way of freedom to provide services, the policy-holder shall, before any commitment is entered into, be informed of the Member State in which the head office, agency or branch with which the contract is to be concluded is established .
Any document issued to the policy-holder or to the insured shall contain the information referred to in the preceding subparagraph .
2 . The contract or other document granting cover, together with the assurance proposal where it is binding upon the proposer, shall specify the address of the establishment which grants the cover and that of the head office .
Article 23
Every establishment must inform its supervisory authority in respect of operations effected by way of provision of services of the amount of the premiums, without deduction of reinsurance, receivable by Member State and by each of classes I to VI, as defined in the Annex to the First Directive .
This information shall be provided separately for commitments covered in accordance with the arrangements in Article 12 and for those covered in accordance with the arrangements in Article 14 .
The supervisory authority of each Member State shall forward this information to the supervisory authorities of each of the Member States of provision of services which so requests .
Article 24
1 . Where the provision of services is conditional upon authorization by the Member State of provision of services, the amount of the technical reserves, including mathematical
reserves, and the rules on profit sharing and on the surrender and paid-up values of the contracts concerned shall be determined under the supervision of that Member State in accordance with the rules it has laid down or, failing such rules, in accordance with established practice in that Member State . The covering of those reserves by equivalent and matching assets, the location of those assets and the application of the rules on profit sharing and on surrender and paid-up values shall be under the supervision of that Member State in accordance with its rules or practice .
2 . In all other cases, those various operations shall be under the supervision of the Member State of establishment, in accordance with its rules or practice .
3 . The Member State of establishment shall ensure that the reserves relating to all the contracts which the undertaking concludes through the establishment concerned are sufficient and covered by equivalent and matching assets .
4 . In the circumstances referred to in paragraph 1, the Member State of establishment and the Member State of provision of services shall exchange any information necessary for carrying out their respective duties under paragraphs 1 and 3 .
Article 25
Without prejudice to any subsequent harmonization, every assurance contract concluded by way of freedom to provide services shall be subject only to the indirect taxes and parafiscal charges on assurance premiums of the
Member State of the commitment within the meaning of Article 2 ( e ) and, in the case of Spain, to the surcharges legally fixed to assist the Spanish body "Consorcio de Compensacion de Seguros' in its function of compensating for losses resulting form the occurrence of exceptional events in that Member State .
The law applicable to the contract pursuant to Article 4 shall not affect the tax arrangements applicable .
Subject to future harmonization, each Member State shall apply to undertakings which provide services in the territory its own national provisions concerning measures to ensure the collection of indirect taxes and parafiscal charges due under the first paragraph .
TITLE IV
Transitional provisions
Article 26
The following transitional arrangements shall apply for the benefit of Spain until 31 December 1995 and of Greece and Portugal until 31 December 1998 :
_ they may limit the commitments for which they are the Member State of provision of services to those entered into in accordance with the arrangements referred to in Article 13,
_ they may require that the technical reserves, including mathematical reserves, relating to those commitments, should be calculated, covered and located in accordance with their national legislation in force .
Article 27
1 . In the case of group assurance contracts entered into by virtue of the insured person's contract of employment or professional activity, any Member State may, until 31 December 1994, limit the commitments for which it is the Member State of provision of services to those entered into in accordance with the arrangements referred to in Article 12 .
2 . Member States may, up to three years at the latest after the date of application laid down in the second paragraph of Article 30, consider that the policy-holder shall be deemed to have taken the initiative only in the case provided for in the first indent of Article 13 ( 1 ).
TITLE V
Final provisions
Article 28
The Commission and the competent authorities of the Member States shall collaborate closely with a view to facilitating the supervision of the kinds of insurance and the operations referred to in the First Directive within the Community .
Each Member State shall inform the Commission of any major difficulties to which application of this Directive gives rise, inter alia any arising if a Member State becomes aware of an abnormal transfer of business referred to in the first Directive to the detriment of undertakings established in its territory and to the advantage of agencies and branches located just beyond its borders .
The Commission and the competent authorities of the Member States concerned shall examine such difficulties as quickly as possible in order to find an appropriate solution .
Where necessary, the Commission shall submit appropriate proposals to the Council .
Article 29
The Commission shall forward to the European Parliament and the Council regular reports, the first on 20 November 1995, on the development of the market in assurance and operations transacted under conditions of freedom to provide services .
Article 30
Member States shall amend their national provisions to comply with this Directive within 24 months of the date of its notification ( 1 ) and shall forthwith inform the Commission thereof .
The provisions amended in accordance with the first paragraph shall be applied within 30 months of the date of notification of this Directive .
Article 31
Upon notification of this Directive, Member States shall ensure that the texts of the main laws, regulations or administrative provisions which they adopt in the field covered by this Directive are communicated to the Commission .
Article 32
This Directive is addressed to the Member States . | [
"UKSI19931327",
"UKSI19931092",
"UKSI19930174"
] |
31990L0604 | 1990 | Council Directive 90/604/EEC of 8 November 1990 amending Directive 78/660/EEC on annual accounts and Directive 83/349/EEC on consolidated accounts as concerns the exemptions for small and medium-sized companies and the publication of accounts in ecus
Having regard to the Treaty establishing the European Economic Community, and in particular Article 54 thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the harmonization of the national provisions concerning the presentation and content of annual accounts and of the annual report, the valuation methods and the publication of these documents as concerns, in particular, public and private limited liability companies was the subject of Directive 78/660/EEC (4), as last amended by the Act of Accession of Spain and Portugal;
Whereas the administrative procedures imposed on small and medium-sized undertakings should be simplified in accordance with the Council resolution of 3 November 1986 on the action programme for small and medium-sized undertakings (SMUs) (5) and the Council resolution of 30 June 1988 on the improvement of the business environment and action to promote the development of enterprises, especially small and medium-sized enterprises in the Community (6), which calls more especially for a substantial simplification of the obligations arising from Directive 78/660/EEC;
Whereas, on the basis of Article 53 (2) of Directive 78/660/EEC, it is appropriate that a second review of the thresholds defining small and medium-sized undertakings should be carried out;
Whereas the derogations as regards establishment, audit and publication of accounts which Member States may provide for under Directive 78/660/EEC should be increased as far as small companies are concerned;
Whereas Member States should be afforded the possibility of allowing companies not to include in the notes to the accounts certain information concerning remuneration granted to members of the company's administrative or management body where such information enables the position of a given member of such bodies to be identified;
Whereas it is also appropriate to enable Member States to render less stringent the obligations imposed on small companies as regards the drawing up and publication of the notes to the accounts; whereas Member States should be able to exempt such companies from the obligation to supply, in the notes to the accounts, certain data which may be deemed of less importance for small companies; whereas, with the same interests in view, Member States should have the possibility of exempting such companies from the obligation to draw up an annual report providing they include, in the notes to the accounts, the data referred to in Article 22 (2) of Directive 77/91/EEC (7) concerning the acquisition of own shares;
Whereas it is important to promote European monetary integration by allowing companies, at least, to publish their accounts in ecus; whereas this is simply an additional facility which does not change the position of companies which can at present already draw up and publish accounts in ecus; whereas, on this point, the provisions of Directives 78/660/EEC and 83/349/EEC (1), as amended by the Act of Accession of Spain and Portugal should be clarified by obliging companies which have recourse to this facility to indicate the conversion rate used in the notes to the accounts,
Article 1
Article 11 of Directive 78/660/EEC is hereby amended as follows:
1. 'balance sheet total: ECU 1 550 000' is hereby replaced by 'balance sheet total: ECU 2 000 000';
2. 'net turnover: ECU 3 200 000' is hereby replaced by 'net turnover: ECU 4 000 000';
3. the following paragraph is hereby added:
'Member States may waive the application of Article 15 (3) (a) and (4) to the abridged balance sheet'.
The revision of the above amounts in ecus shall constitute the second five-yearly revision provided for in Article 53 (2) of Directive 78/660/EEC.
Article 2
Article 27 of Directive 78/660/EEC is hereby amended as follows:
1. 'balance sheet total: ECU 6 200 000' is hereby replaced by 'balance sheet total: ECU 8 000 000';
2. 'net turnover: ECU 12 800 000' is hereby replaced by 'net turnover: ECU 16 000 000'.
The revision of the above amounts in ecus shall constitute the second five-yearly revision provided for in Article 53 (2) of Directive 78/660/EEC.
Article 3
Article 53 (1) of Directive 78/660/EEC shall be replaced by the following:
'1. For the purposes of this Directive, the ecu shall be that defined in Regulation (EEC) No 3180/78 (*), as amended by Regulation (EEC) No 2626/84 (**), and by Regulation (EEC) No 1971/89 (***).
The equivalent in national currency shall be that applying on 8 November 1990.
(*) OJ No L 379, 30. 12. 1978, p. 1.
(**) OJ No L 247, 16. 9. 1984, p. 1.
(***) OJ No L 189, 4. 7. 1989, p. 1.'
Article 4
The following paragraph is hereby added to Article 43 of Directive 78/660/EEC:
'3. Member States may waive the requirement to provide the information referred to in paragraph 1 point 12 where such information makes it possible to identify the position of a specific member of such a body.'
Article 5
Article 44 of Directive 78/660/EEC is hereby replaced by the following:
'Article 44
1. Member States may permit companies covered by Article 11 to draw up abridged notes on their accounts without the information prescribed in Article 43 (1) points 5 to 12. However, the notes must disclose the information prescribed in Article 43 (1) point 6 in total for all the items concerned.
2. Member States may also permit the companies referred to in paragraph 1 to be exempted from the obligation to disclose in the notes on their accounts the information prescribed in Article 15 (3) (a) and (4), Articles 18, 21 and 29 (2), the second subparagraph of Article 30, Article 34 (2), Article 40 (2) and the second subparagraph of Article 42.
3. Article 12 shall apply.'
Article 6
The following paragraph is hereby added to Article 46 of Directive 78/660/EEC;
'3. Member States may waive the obligation on companies covered by Article 11 to prepare annual reports, provided that the information referred to in Article 22 (2) of Directive 77/91/EEC concerning the acquisition by a company of its own shares is given in the notes to their accounts.'
Article 7
Article 47 (2) (b) of Directive 78/660/EEC is hereby replaced by the following:
'(b) abridged notes on their accounts in accordance with Article 44.'
Article 8
The following Article is hereby inserted in Directive 78/660/EEC:
'Article 50a
Annual accounts may be published in the currency in which they were drawn up and in ecus, translated at the exchange rate prevailing on the balance sheet date. That rate shall be disclosed in the notes on the accounts.'
Article 9
The following Article is hereby inserted in Directive 83/349/EEC:
'Article 38a
Consolidated accounts may be published in the currency in which they were drawn up and in ecus, translated at the exchange rate prevailing on the consolidated balance sheet date. That rate shall be disclosed in the notes on the accounts.'
Article 10
1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive by 1 January 1993. They shall forthwith inform the Commission thereof.
2. Member States may provide that this Directive shall only apply for the first time to accounts for the financial year beginning on 1 January 1995 or during the calendar year 1995.
3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Article 11
This Directive is addressed to the Member States. | [
"UKSI19922452"
] |
31990L0605 | 1990 | Council Directive 90/605/EEC of 8 November 1990 amending Directive 78/660/EEC on annual accounts and Directive 83/349/EEC on consolidated accounts as regards the scope of those Directives
Having regard to the Treaty establishing the European Economic Community, and in particular Article 54 thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Directive 78/660/EEC (4), as last amended by Directive 90/604/EEC (5), applies to the annual accounts of public and private limited liability companies in particular because those types of company offer no safeguards to third parties beyond the amounts of their net assets;
Whereas, in accordance with Directive 83/349/EEC (6), as last amended by Directive 90/604/EEC, Member States need require only companies covered by Directive 78/660/EEC to draw up consolidated accounts;
Whereas, within the Community, there is a substantial and constantly growing number of partnerships and limited partnerships all of the fully liable members of which are constituted either as public or as private limited liability companies;
Whereas these fully liable members may also be companies which do not fall within the law of a Member State but which have a legal status comparable to that referred to in Directive 68/151/EEC (7);
Whereas it would run counter to the spirit and aims of those Directives to allow such partnerships and partnerships with limited liability not to be subject to Community rules;
Whereas the provisions covering the scope of the two Directives in question should therefore be explicitly supplemented;
Whereas it is of importance that the name, head office and legal status of any undertaking of which a limited liability company is a fully liable member should be indicated in the notes to the accounts of such member;
Whereas the obligation to draw up, publish and to have audited the accounts of partnerships and limited liability partnerships may also be imposed on the fully liable member; whereas it should also be possible to include these companies in consolidated accounts, drawn up by such member or established at a higher level;
Whereas some of the partnerships covered by this Directive are not subject, in the Member State where they have their head office, to entry in a register, which makes it difficult to apply accounting obligations to them; whereas, in particular in these cases, special rules are necessary according to whether the fully liable members are undertakings which fall within the law of the same Member State, another Member State or a third country,
Article 1
Directive 78/660/EEC is hereby amended as follows:
1. the following subparagraphs are added to Article 1 (1):
'The coordination measures prescribed by this Directive shall also apply to the Member States' laws, regulations and administrative provisions relating to the following types of company:
(a) in Germany:
die offene Handelsgesellschaft, die Kommanditgesellschaft;
(b) in Belgium:
la société en nom collectif/de vennootschap onder firma,
la société en commandité simple/de gewone commanditaire vennootschap;
(c) in Denmark:
interessentskaber, kommanditselskaber;
(d) in France:
la société en nom collectif, la société en commandite simple;
(e) in Greece:
i omórrythmos etaireía, i eterórrythmos etaireía;
(f) in Spain:
sociedad colectiva, sociedad en comandita simple;
(g) in Ireland:
partnerships, limited partnerships, unlimited companies;
(h) in Italy:
la società in nome collettivo, la società in accomandita semplice;
(i) in Luxembourg:
la société en nom collectif, la société en commandite simple;
(j) in the Netherlands:
de vennootschap onder firma, de commanditaire vennootschap;
(k) in Portugal:
sociedade em nome colectivo, sociedade em comandita simples;
(l) in the United Kingdom:
partnerships, limited partnerships, unlimited companies,
where all members having unlimited liability are companies of the types set out in the first subparagraph or companies which are not governed by the laws of a Member State but which have a legal form comparable to those referred to in Directive 68/151/EEC.
This Directive shall also apply to the types of companies or firms referred to in the second subparagraph where all members having unlimited liability are themselves companies of the types set out in that or the first subparagraph.';
2. the following subparagraph is added in Article 43 (1), point 2:
'the name, the head or registered office and the legal form of each of the undertakings of which the company or firm is a member having unlimited liability. This information may be omitted where for the purposes of Article 2 (3) it is of negligible importance only';
3. the following paragraph is inserted in Article 47:
'1a. The Member State of a company or firm referred to in Article 1 (1), second and third subparagraphs (entity concerned) may exempt that entity from publishing its accounts in accordance with Article 3 of Directive 68/151/EEC, provided that those accounts are available to the public at its head office, where:
(a) all the members having unlimited liability of the entity concerned are the companies referred to in the first subparagraph of Article 1 (1) governed by the laws of Member States other than the Member State whose law governs that entity and none of those companies publishes the accounts of the entity concerned with its own accounts; or
(b) all the members having unlimited liability are companies which are not governed by the laws of a Member State but which have a legal form comparable to those referred to in Directive 68/151/EEC.
Copies of the accounts must be obtainable upon request. The price of such a copy may not exceed its administrative cost. Appropriate sanctions must be provided for failure to comply with the publication obligation imposed in this paragraph.';
4. the following Article is inserted:
'Article 57a
1. Member States may require the companies referred to in the first subparagraph of Article 1 (1) governed by their law, which are members having unlimited liability of any of the companies and firms listed in Article 1 (1), second and third subparagraphs (entity concerned), to draw up, have audited and publish, with their own accounts, the accounts of the entity concerned in conformity with the provisions of this Directive.
In this case, the requirements of this Directive do not apply to the entity concerned.
2. Member States need not apply the requirements of this Directive to the entity concerned where:
(a) the accounts of this entity are drawn up, audited and published in conformity with the provisions of this Directive by a company which is a member having unlimited liability of the entity and is governed by the law of another Member State;
(b) the entity concerned is included in consolidated accounts drawn up, audited and published in accordance with Directive 83/349/EEC by a member having unlimited liability or where the entity concerned is included in the consolidated accounts of a larger body of undertakings drawn up, audited and published in conformity with Council Directive 83/349/EEC by a parent undertaking governed by the law of a Member State. The exemption must be disclosed in the notes on the consolidated accounts.
3. In these cases, the entity concerned must reveal to whomsoever so requests the name of the entity publishing the accounts.'
Article 2
Directive 83/349/EEC is hereby amended as follows:
1. the following subparagraph is inserted in Article 4 (1):
'The first subparagraph shall also apply where either the parent undertaking or one or more subsidiary undertakings is constituted as one of the types of company mentioned in Article 1 (1), second or third subparagraph of Directive 78/660/EEC.';
2. In Article 4, paragraph 2 is replaced by the following:
'2. The Member States may, however, grant exemption from the obligation imposed in Article 1 (1) where the parent undertaking is not constituted as one of the types of company mentioned in Article 4 (1) of this Directive or in Article 1 (1), second or third subparagraph of Directive 78/660/EEC.' Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive before 1 January 1993. They shall forthwith inform the Commission thereof.
2. Member States may provide that the provisions referred to in paragraph 1 shall first apply to the annual accounts and consolidated accounts for financial years beginning on 1 January 1995 or during the 1995 calendar year.
3. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19931820"
] |
31991L0495 | 1990 | Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas rabbit meat and farmed game meat are included in the list of products in Annex II to the Treaty; whereas rabbit and game farming are generally included in the farming sector; whereas this farming constitutes a source of income for part of the farming population;
Whereas, in order to ensure the rational development of this sector and to improve productivity, rules concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat must be laid down at Community level;
Whereas disparities as regards animal health and public health conditions in the Member States should be eliminated in order to encourage intra-Community trade in rabbit meat and farmed game meat, with a view to the completion of the internal market;
Whereas diseases transmissible to domestic animals and humans may be spread by rabbit meat and farmed game meat; whereas it is necessary to lay down rules enabling these risks to be controlled;
Whereas the meat in question must be treated in good hygienic conditions in order to avoid food-borne infections and intoxications;
Whereas Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (4), as last amended by Directive 89/162/EEC (5), lays down the conditions for notification of animal diseases in the Community; whereas it is opportune to have, for certain contagious diseases affecting farmed game, the same information as for other domestic animals;
Whereas Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (6), as last amended by Directive 89/662/EEC (7) and Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (8), as last amended by Directive 90/539/EEC (9), lay down the health requirements for, respectively, fresh meat and fresh poultrymeat; whereas farmed wildlife used for game production is similar to farmed mammals and farmed birds; whereas it is therefore opportune to extend to farmed game meat, while taking into account certain specific aspects, the health rules already applied for trade in fresh meat and poultrymeat;
Whereas it is appropriate to lay down exceptions for small quantitites of rabbit meat and farmed game meat used for local trade;
Whereas, in respect of the organization of, and the follow-up to, the checks to be carried out by the Member State of destination and the safeguard measures to be implemented, reference should be made to the general rules laid down in Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zoo-technical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (10);
Whereas the Commission should be entrusted with the task of adopting measures for applying this Directive; whereas, to that end, provision should be made for procedures establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee,
CHAPTER I General rules
Article 1
This Directive lays down requirements concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat.
Article 2
For the purposes of this Directive, the definitions given in Article 2 of Directive 64/433/EEC and in Article 2 of Directive 71/118/EEC shall apply.
The following definitions shall also apply:
1. 'rabbit meat': all parts of domestic rabbit which are fit for human consumption;
2. 'farmed game meat': all parts of wild land mammals and wild birds - including the species referred to in Article 2 (1) of Directive 90/539/EEC - bred, reared and slaughtered in captivity which are fit for human consumption;
3. 'farmed game': land mammals, or birds, which are not considered as domestic and not referred to in Article 1 (1) of Directive 64/433/EEC or in Article 1 of Council Directive 71/118/EEC, but which are farmed as domestic animals. However, wild mammals living within an enclosed territory under conditions of freedom similar to those enjoyed by wild game shall not be deemed farmed game;
4. 'country of production': the Member State in the territory of which the farm of production is situated.
CHAPTER II Rules applicable to the production and placing on the market of rabbit meat
Article 3
1. Member States shall see to it that rabbit meat:
(a) is obtained in an establishment fulfilling the general conditions of Directive 71/118/EEC and approved for the purposes of this chapter in accordance with Article 14;
(b)
comes from animals from farms or areas in which bans have not been imposed for veterinary inspection reasons;
(c)
comes from animals which have undergone ante-mortem inspection by an official veterinarian or by assistants, in accordance with Article 4 of Directive 71/118/EEC, such inspection being in accordance with Chapter I of Annex I to this Directive and which have been deemed suitable for slaughter following such inspection;
(d)
has been treated under satisfactory hygiene conditions similar to those provided for in Chapter V of Annex I to Directive 71/118/EEC, except for those in points 28a and 28b;
(e)
has undergone, in accordance with Chapter II of Annex I to this Directive, post-mortem inspection by an official veterinarian or, pursuant to Article 4 of Directive 71/118/EEC, by assistants, and has not shown any change except for traumatic lesions which occurred shortly before slaughter or localized malformations or changes, provided that it is established, if necessary by appropriate laboratory tests, that these do not render the carcase or offal unfit for human consumption or dangerous to human health;
(f)
bears a health mark in accordance with Chapter III of Annex I to this Directive.
A decision may be taken, where appropriate, to amend or supplement the provisions of the aforementioned Chapter in accordance with the procedure provided for in Article 20, in order to take into account notably the different forms of presentation, providing they conform to the rules covering hygiene; in particular, and by way of derogation from the said Chapter, the said procedure shall determine - before 1 January 1992 for the first time - the conditions under which the marketing, in large packages, which have not been marked in accordance with section 11.3 (a) of the said Chapter, of carcases, parts of carcases or of offal may be authorized;
(g)
is stored in accordance with Chapter IV of Annex I to this Directive after post-mortem inspection under satisfactory hygiene conditions in establishments approved in accordance with Article 14 or in stores approved in accordance with Community rules;
(h)
has been transported under satisfactory hygiene conditions in accordance with Chapter V of Annex I to this Directive;
(i)
in the case of parts of carcases or boned meat, has
also been obtained in conditions similar to those provided for in Article 3 of Directive 71/118/EEC, in establishments specially approved for this purpose in accordance with Article 14 of this Directive.
2. Each Member State shall also see to it that fresh rabbit meat sent to the territory of another Member State is accompanied by a health certificate during its transport to the country of destination.
The original of the health certificate, which must accompany the fresh rabbit meat during its transport to the consignee,
must be issued by an official veterinarian at the moment of loading. The health certificate must correspond, in presentation and context, to the model in Annex II; it must be drawn up at least in the language or languages of the country of destination and must contain the information provided for in the model in the said Annex.
Article 4
1. By way of derogation from Article 3, Member States may authorize:
(a) the direct supply of rabbit meat by a small producer to a private individual for his own consumption;
(b)
the supply of fresh rabbit meat in small quantities, by farmers who produce rabbits on a small scale:
- either directly to the final consumer at those local markets which are closest to their farms,
- or to a retailer with a view to direct sale to the final consumer, provided that such retailer conducts his business in the same locality as that of the producer or in a neighbouring locality.
The said possible derogation shall not include itinerant sales, mail order sales and, as far as the retailer is concerned, sales on a market.
2. Member States shall take the measures necessary to ensure the health control of these operations provided for in paragraph 1 and to adopt rules enabling the original holding of such meat to be traced.
3. Under the procedure laid down in Article 20, the Commission may adopt the detailed rules for applying this Article and in particular, at the request of Member State, fix the maximum limits of quantities which may be supplied pursuant to paragraph 1.
CHAPTER III Rules applicable to the production and marketing of farmed game meat
Article 5
Member States shall ensure that intra-Community trade in farmed game meat is subject:
(a) where farmed game birds are concerned, to the requirements of Council Directive 91/494/EEC of
26 June 1990 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat (;);
(b)
where other species of farmed game are concerned, to the requirements of Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat ($), as last amended by Directive 89/662/EEC.
Article 6
1. Farmed game meat obtained from cloven-hoofed wild land mammals shall fulfil the relevant conditions referred to in Article 3 and Article 5 (b) to (k) of Directive 64/433/EEC, provided that the original herd undergoes regular veterinary inspection and is not under any restrictions following the survey performed according to Article 11 or as a result of veterinary inspection. The detailed rules for this inspection shall be laid down in accordance with the procedure set out in Article 20.
The animals in question shall be treated at different times from bovine animals, swine, sheep and goats.
The health certificate which must accompany such meat shall correspond to the model in Annex IV to this Directive.
Meat from farmed wild pigs or other species sensitive to Trichina infestation shall be subjected to examination by digestion in accordance with Council Directive 77/96/EEC of 21 December 1976 on examination for Trichinae (trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine (11) as last amended by Directive 89/321/EEC (12).
2. Notwithstanding paragraph 1, the official service may authorize the slaughter of farmed game in the place of origin, where it cannot be transported, in order to avoid any risk for the handler or to protect the welfare of the animals. This authorization may be granted provided that:
- the herd undergoes regular veterinary inspection and is not under any restrictions following the survey performed according to Article 12 or as a result of veterinary inspection,
- a request is submitted by the owner of the animals,
- the official service is informed in advance of the date of slaughtering of the animals,
- the holding has a centre for mustering wild animals where an ante-mortem inspection of the group for slaughter can be carried out,
- the holding has premises suitable for the slaughter, sticking and bleeding of the animals,
- slaughter by means of sticking and bleeding is preceded by stunning, which must be carried out in the conditions laid down in Directive 74/577/EEC (13); the veterinary service may authorize shooting only in special cases,
- the slaughtered and bled animals are hung as quickly as possible after slaughter and are transported under satisfactory hygiene conditions to a slaughterhouse approved in accordance with Directive 66/433/EEC. Where game slaughtered at the place of rearing cannot be brought within the hour to a slaughterhouse approved in accordance with Article 8 of Directive 64/433/EEC, it must be transported in a container or means of transport in which the ambient temperature is maintained at between 0 oC and 4 oC. Evisceration must be carried out no later than three hours after stunning,
- during transportation to the slaughterhouse the slaughtered animals are accompanied by a certificate issued by the veterinary service attesting to the favourable outcome of the ante-mortem inspection, the correct conduct of bleeding and the time of slaughter; this certificate must correspond to the model in Annex III.
3. Pending the adoption of health rules applicable to meat reserved for the domestic market, the slaughtering of farmed big game and the cutting and storage of the meat referred
to in paragraph 1 may, by way of derogation from paragraph 1, be performed in establishments approved by the national authorities for the domestic market, provided that such meat does not enter intra-Community trade.
Article 7
1. Countries of destination may, with due regard for the general provisions of the Treaty, grant one or more countries of consignment general authorizations or authorizations restricted to specific cases, whereby the fresh meat referred to in Article 5 (b) and (i) to (k) of Directive 64/433/EEC may be admitted to their territory.
Such fresh meat may be sent solely in accordance with Article 3 (1) and (3) of Directive 64/433/EEC.
2. If a country of destination grants a general authorization in accordance with paragraph 1, it shall immediately inform the other Member States and the Commission thereof.
3. The countries of consignment shall make all necessary arrangements to ensure that health certificates, a specimen of which is provided in Annex IV, mention that one of the options provided for in paragraph 1 has been taken up.
Article 8
Meat of farmed game birds shall fulfil the conditions referred to in Article 3 of Directive 71/118/EEC.
Meat of farmed game birds intended for intra-Community trade shall be accompanied by the health certificate provided for in Article 8 of Directive 71/118/EEC, which shall correspond to the model in Annex IV to this Directive.
However, notwithstanding Chapter V (23) of Annex I to Directive 71/118/EEC, where, in the case of quail and pigeon, the evisceration technique used does not permit complete health inspection of the viscera of each bird, that inspection may be carried out on a sample of at least 5 % of each batch of 500 birds, and in corresponding proportion beyond 500 birds, provided that the batches are homogeneous in terms of their nature, weight and origin.
Where the results are not clearly satisfactory, the opinion expressed on the basis of such sample inspection of the viscera as to whether the slaughtered birds are fit for consumption shall apply to the entire batch.
Article 9
Notwithstanding Article 8, first subparagraph, in the case of meat from farmed game birds obtained and put on the market in their territory, Member States may, with due regard for the general provisions of the Treaty, grant those slaughterhouses or cutting premises situated in their territory which were engaged in that activity prior to the date of notification of this Directive and which expressly so request, a derogation from the slaughter and evisceration provisions laid down in Chapter V of Annex I to Directive 71/118/EEC in the case of the production of partially eviscerated or non-eviscerated farmed game birds.
The use of the health mark provided for in Chapter X of Annex I to Directive 71/118/EEC shall be prohibited in the event that this derogation is exercised.
Article 10
Article 8
shall not apply to meat of farmed game birds which, in isolated cases, is supplied by the producer thereof direct to the final consumer for his own consumption otherwise than by itinerant sale, sale by mail order or sale on a market.
Under the procedure laid down in Article 20, the Commission may adopt the detailed rules for applying this Article and in particular, at the request of Member State, fix the maximum limits of quantities which may be supplied pursuant to the first paragraph.
CHAPTER IV Common provisions
Article 11
1. Member States shall ensure that a survey of the health of rabbit and farmed game is performed on holdings on their territories at regular intervals.
2. To this end a central service or body shall be entrusted with the task of collecting and using the results of the health inspections carried out in accordance with this Directive, where diseases transmissible to humans or animals or the presence of residues in excess of permitted levels are diagnosed.
3. Where a disease or condition referred to in paragraph 2 is diagnosed, the survey results relating to the specific case shall be communicated as soon as possible to the official service responsible for supervision of the stock from which the animals originate.
4. Depending on the epizootic situation, the official service shall carry out specific tests on farmed game in order to detect the presence of the diseases referred to in Annex I to Directive 82/894/EEC.
The presence of these diseases shall be communicated to the Commission and to the other Member States in accordance with the said Directive.
Article 12
1. Member States shall supplement their plans for measures on residues referred to in Article 4 of Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues (14) in order to subject rabbits and farmed game to the inspections provided for in that Directive and also to monitor wild game for contaminants present in the environment.
2. Taking into account the results of the monitoring referred to Article 11 (4), Member States shall impose limitations on the use of game meat from holdings or territories implicated by the monitoring.
3. The Commission shall adopt the detailed rules for application of this Article in accordance with the procedure laid down in Article 20.
Article 13
Rabbit meat or meat of farmed game birds shall not be used for human consumption if:
(a) found to have one of the faults listed in point 9 (a) of Annex I;
(b)
originating from animals to which substances likely to make the meat dangerous or harmful to human health have been administered and on which a decision has been taken, in accordance with the procedure provided for in Article 20, following the opinion of the Scientific Veterinary Committee. Pending that decision, national rules on authorized substances shall remain in force in accordance with the general provisions of the Treaty;
(c)
without prejudice to possible Community regulations applicable in the field of ionization, treated with ionizing or ultraviolet radiaton or treated with tenderizers or other substances which could affect the organoleptic properties of the meat or colorants other than those used for health marking.
Article 14
1. Each Member State shall draw up a list of the establishments approved by it, each establishment having a veterinary approval number. Member States may approve for slaughtering and cutting of rabbit and farmed game establishments approved according to Directive 71/118/EEC or Directive 64/433/EEC, provided that those establishments are equipped for the processing of rabbit meat and/or farmed game meat and that those operations are performed in such a way as to comply with hygiene rules. Member States shall send this list to the other Member States and to the Commission.
2. No Member State shall approve an establishment unless compliance with this Directive is assured. Member States shall withdraw approval if the conditions for granting it cease to be fulfilled.
3. If a check has been made in accordance with Article 16, the Member State concerned shall take account of the conclusions resulting therefrom. The other Member States and the Commission shall be informed of the withdrawal of approval.
4. Inspection and supervision of approved establishments shall be carried out under the responsibility of the official veterinarian who, without prejudice to the tasks devolved to assistants under Directive 71/118/EEC, may be assisted in purely material tasks by staff specially trained for the purpose. The official veterinarian must at all times have free access to all parts of establishments in order to ensure that this Directive is being complied with.
The detailed rules governing this assistance shall be determined in accordance with the procedure laid down in Article 20.
Article 15
Veterinary experts from the Commission may, insofar as it is necessary to ensure uniform application of this Directive,
make on-the-spot checks in co-operation with the competent authorities of the Member States; they may verify whether approved establishments are actually complying with this Directive. The Commission shall inform the Member States of the results of the checks.
A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts carrying out their duties.
The general provisions for implementing this Article shall be determined in accordance with the procedure laid down in Article 20.
Article 16
1. The rules laid down in Council Directive 89/662/EEC concerning veterinary checks to be carried out in intra-Community trade with a view to the completion of the internal market shall apply in particular to the organization of, and the action to be taken following the checks carried out by the country of destination and to the safeguard measures to be applied in relation to health problems affecting the production and distribution of rabbit and game meat in the territory of the Community.
2. Directive 89/662/EEC shall be amended as follows:
(a) in Annex A, the following should be added in fine:
'- Council Directive 91/495/EEC of 27 November 1990 on public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat. (OJ No L 268, 24. 9. 1991, p. 41) (Excluding rabbit meat and farmed game meat imported from third countries)';
(b)
in Annex B, the indent 'rabbit and game meat' shall be replaced by 'wild game meat'.
Article 17
Pending the implementation of Community provisions concerning imports of rabbit and game meat from third countries, Member States shall apply to such imports provisions which are at least equivalent to those of this Directive.
However, pending the implementation of these provisions, Member States shall ensure that imports from third countries remain subject to the rules laid down in the third subparagraph of Article 6 (1) (b) of Directive 89/662/EEC and also that:
i(i) fresh rabbit meat and fresh farmed game meat may not, under any circumstances, bear the public health marking referred to in Chapter X of Annex I to Directive 71/118/EEC and, if cut and boned, must be treated in accordance with Article 3 (1) (B) of that Directive;
(ii)
meat from species susceptible to trichinosis shall be subjected to examination by digestion in accordance with Directive 77/96/EEC.
CHAPTER V Final provisions
Article 18
This Directive shall not affect Community rules adopted in order to protect wildlife.
Article 19
The Annexes to this Directive shall be amended by the Council acting by a qualified majority on a proposal from the Commission in order in particular to bring it into line with technological progress.
Article 20
1. Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter called 'the Committee') set up by Decision 68/361/EEC (15).
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the
case of decisions which the Council is required to adopt
on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
4. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken.
The Council shall act by a qualified majority.
If, upon expiry of a period of three months from the date of referral to the Council, the Council has not acted, the
Commission shall adopt the proposed measures and implement them immediately, save where the Council has decided against the said measures by a simple majority.
Article 21
Pending implementation of Community health and veterinary inspection rules on the production and marketing of meat of wild game to be adopted not later than 31 March 1991, wild game meat fit for consumption shall be subject to the rules of Article 3 (3), the second indent of the second subparagraph of Article 4 (1) and to Article 5 (2) of Directive 89/662/EEC.
Article 22
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1993. They shall forthwith inform the Commission thereof.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 23
This Directive is addressed to the Member States. | [
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31990L0658 | 1990 | Council Directive 90/658/EEC of 4 December 1990 amending certain Directives on the recognition of professional qualifications consequent upon the unification of Germany
Having regard to the Treaty establishing the European Economic Community, and in particular Article 49, Article 57 (1) and (2), first and third sentences, and Article 66 thereof,
Having regard to the proposal from the Commission(1),
In cooperation with the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas, by reason of the unification of Germany, certain amendments should be made to Directives 75/362/EEC(4), 77/452/EEC(5), 78/686/EEC(6), 78/1026/EEC(7) and 80/154/EEC(8), as last amended by Directive 89/594/EEC(9) and Directive 89/595/EEC(10) concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications as doctors, nurses responsible for general care, dental practitioners, veterinary surgeons and midwives respectively, and to Directive 85/433/EEC(11), as amended by Directive 85/584/EEC(12), and Directive 85/384/EEC(13), as last amended by Directive 86/17/EEC(14), concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in the field of pharmacy and architecture respectively and to Directive 75/363/EEC(15), as last amended by Directive 89/594/EEC, concerning the coordination of provisions laid down by law, regulation or administrative action relating to the activities of doctors;
() () Whereas from the date of German unification Community law will be fully applicable to the territory of the former German Democratic Republic;
Whereas it is necessary to make changes to the said Directives to take account of the specific situation in the said territory;
Whereas, in accordance with the principle of acquired rights, the diplomas, certificates or other evidence of formal qualifications held by German nationals in that territory who are pursuing their professional activities on the basis of training which began before unification and does not conform to Community rules on training should be granted recognition under similar conditions to those applied to other nationals of Member States at the time of the adoption of the said Directives or accessions to the Community;
Whereas it is necessary to protect at Community level the rights acquired by the holders of former qualifications which are no longer awarded as a result of changes which have taken place in the rules of the Member States which awarded the qualification to them; whereas such a provision was introduced by Directive 89/594/EEC into most Directives on the mutual recognition of diplomas, certificates and other evidence of formal qualifications; whereas it could also be applied, unamended, to German nationals from the territory of the former German Democratic Republic; whereas a similar provision should also be incorporated into Directive 85/433/EEC relating to the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy;
Whereas most of the specific provisions relating to the recognition of diplomas, certificates or other evidence of formal qualifications awarded by the former German Democratic Republic cease to be relevant as a result of German unification; whereas they should be repealed,
Article 1
Directive 75/362/EEC is hereby amended as follows:
1.In Article 3 (a), point 3, 'in Germany' shall be deleted.
2.The following Article shall be inserted:
'Article 9a
1. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications in medicine attest to training received on the territory of the former German Democratic Republic which does not satisfy all the minimum training requirements laid down in Article 1 of Directive 75/363/EEC, Member States other than Germany shall recognize those diplomas, certificates and other evidence of formal qualifications as being sufficient proof if:
they attest to training commenced before German unification,
they entitle the holder to pursue the activities of a doctor throughout the territory of Germany under the same conditions as the qualifications awarded by the competent German authorities and referred to in points 1 and 2 of Article 3 (a), and
they are accompanied by a certificate issued by the competent German authorities stating that those nationals have effectively and lawfully been engaged in the activities in question in Germany for at least three consecutive years during the five years prior to the date of issue of the certificate.
2. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications in specialized medicine attest to training received on the territory of the former German Democratic Republic which does not satisfy the minimum training requirements laid down in
Articles 2 to 5 of Directive 75/363/EEC, Member States other than Germany shall recognize those diplomas, certificates and other evidence of formal qualifications as being sufficient proof if:
they attest to training commenced before the expiry of the time limit laid down in Article 9 (1), second subparagraph, of Directive 75/363/EEC, and
they permit the pursuit, as a specialist, of the activity in question throughout the territory of Germany under the same conditions as the qualifications awarded by the competent German authorities and referred to in Articles 5 and 7.
They may, however, require that these diplomas, certificates or other evidence of formal qualifications be accompanied by a certificate issued by the competent German authorities or bodies stating that the holders have, as specialists, been engaged in the activity in question for a period equivalent to twice the difference between the period of specialized training received on German territory and the minimum duration of training laid down in Directive 75/363/EEC, where they do not satisfy the minimum requirements regarding the duration of training laid down in Articles 4 and 5 of Directive 75/363/EEC.' Article 2 The following second subparagraph is hereby added to Article 9 (1) of Directive 75/363/EEC:
'For the territory of the former German Democratic Republic, however, Germany shall take the measures necessary to comply with Articles 2 to 5 within
18 months of unification.' Article 3 Directive 77/452/EEC is hereby amended as follows:
1.In Article 3 (a), the second indent, 'in Germany' shall be deleted;
2.The following Article shall be inserted:
'Article 4a
In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications as nurses responsible for general care attest to training received on the territory of the former German Democratic Republic which does not satisfy all the minimum training requirements laid down in Article 1 of Directive 77/453/EEC, Member States other than Germany shall recognize those diplomas, certificates and other evidence of former qualifications as being sufficient proof if:
they attest to training commenced before German unification,
they entitle the holder to pursue the activities of a nurse responsible for general care throughout the territory of Germany under the same conditions as the qualifications awarded by the competent German authorities and referred to in Article 3 (a), and
they are accompanied by a certificate issued by the competent German authorities stating that those nationals have effectively and lawfully been engaged in the activities of nurse responsible for general care in Germany for at least three years during the five years prior to the date of issue of the certificate. These activities must have included taking full responsibility for the planning, organization and carrying-out of the nursing care of the patient.' Article 4 Directive 78/686/EEC is hereby amended as follows:
1.In Article 3 (a), 'in Germany', the following shall be deleted:
presentation in the form of two numbered points,
the text of point 2;
2.The following Article shall be inserted:
'Article 7 a
1. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications as dental practitioner attest to training received on the territory of the former German Democratic Republic which does not satisfy all the minimum training requirements laid down in Article 1 of Directive 78/687/EEC, Member States other than Germany shall recognize those diplomas, certificates and other evidence of formal qualifications as being sufficient proof if:
they attest to training commenced before German unification,
they entitle the holder to pursue the activities of a dental practitioner throughout the territory of Germany under the same conditions as the qualifications awarded by the competent German authorities and referred to in Article 3 (a), and
they are accompanied by a certificate issued by the competent German authorities stating that those nationals have effectively and lawfully been engaged in the activities in question in Germany for at least three consecutive years during the five years prior to the date of issue of the certificate.
2. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications as specialist dental practitioners attest to training received in the territory of the former German Democratic Republic which does not satisfy the minimum training requirements laid down in Articles 2 and 3 of Directive 78/687/EEC, Member States other than Germany shall recognize those diplomas, certificates and other evidence of formal qualifications as being sufficient proof if:
they attest to training commenced before German unification, and
they entitle the holder to pursue, as a specialist dental practitioner, the activity in question throughout the territory of Germany under the same conditions as the qualifications awarded by the competent German authorities and referred to in Article 5 (1) and (2).
They may, however, require that these diplomas, certificates or other evidence of formal qualifications be accompanied by a certificate issued by the competent German authorities or bodies stating that the holder has, as a specialist dental practitioner, been engaged in the activity in question for a period equivalent to twice the difference between the period of specialized training received on German territory and the minimum duration of training laid down in Directive 78/687/EEC, where they do not satisfy the minimum requirements regarding the duration of training laid down in Article 2 of Directive 78/687/EEC.'
Article
Article 5
Directive 78/1026/EEC is hereby amended as follows:
1.In Article 3 (a), 'in Germany', the following shall be deleted:
presentation in the form of two numbered points,
the text of point 2.
2.The following Article shall be inserted:
'Article 4a
In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications as veterinary surgeons attest to training received in the territory of the former German Democratic Republic which does not satisfy all the minimum training requirements laid down in Article 1 of Directive 78/1027/EEC, Member States other than Germany shall recognize those diplomas, certificates and other evidence of formal qualifications, as being sufficient proof if:
they attest to training commenced before German unification;
they entitle the holder to pursue the activities of a veterinary surgeon throughout the territory of Germany under the same conditions as the qualifications awarded by the competent German authorities and referred to in Article 3 (a), and
they are accompanied by a certificate issued by the competent German authorities stating that those nationals have effectively and lawfully been engaged in the activities in question in Germany for at least three consecutive years during the five years prior to the date of issue of the certificate.'
Article
Article 6
Directive 80/154/EEC is hereby amended as follows:
1.In Article 3 (a) 'in Germany' the following shall be deleted:
presentation in the form of two indents,
the text of the second indent.
2.the following Article shall be added:
'Article 5a
1. In the case of Member States whose diplomas, certificates and other evidence of formal qualifications as midwife attest to training received on the territory of the former German Democratic Republic which does not satisfy all the minimum training requirements laid down in Article 1 of Directive 80/155/EEC, Member States other than Germany shall recognize those diplomas, certificates and other evidence of formal qualifications as being sufficient proof if:
they attest to training commenced before German unification;
they entitle the holder to pursue the activities of a midwife throughout the territory of Germany under the same conditions as the qualifications awarded by the competent German authorities and referred to in Article 3 (a), and
they are accompanied by a certificate issued by the competent German authorities stating that those nationals have effectively and lawfully been engaged in the activities in question in Germany for at least three years during the five years prior to the date of issue of the certificate.
2. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications as midwives attest to training received in the territory of the former German Democratic Republic which satisfies all the minimum training requirements laid down in Article 1 of Directive 80/155/EEC but which, pursuant to Article 2, has to be recognized only if it is complemented by the professional practice referred to in Article 4, Member States other than Germany shall recognize those diplomas, certificates and other evidence of formal qualifications as being sufficient proof if:
they attest to training commenced before German unification, and
they are accompanied by a certificate stating that those nationals have effectively and lawfully been engaged in the activities in question in Germany for at least two years during the five years prior to the date of issue of the certificate.' Article 7 Directive 85/433/EEC is hereby amended as follows:
1.In Article 4 (a), 'in Germany', the following shall be deleted:
presentation in the form of two numbered points,
the text of point 2.
2.In Article 6:
the present text becomes paragraph 1,
the following paragraph 2 shall be added:
'2. Diplomas, certificates and other university or equivalent qualifications in pharmacy which were awarded to nationals of Member States by Member States and which satisfy all the minimum training requirements laid down in Article 2 of Directive 85/432/EEC but which do not conform to the designations set out in Article 4 shall be treated, for the purposes of the Directive, as the diplomas set out in that Article if they are accompanied by a certificate stating that they attest to training conforming to the provisions of Directive 85/432/EEC referred to in Article 2 of this Directive and shall be treated by the Member States which awarded them as those designations are set out in Article 4 of this Directive.'
3.The following Article shall be inserted:
'Article 6a
Diplomas, certificates and other university or equivalent qualifications in pharmacy which attest to training received by nationals of the Member States on the territory of the former German Democratic Republic and which do not satisfy all the minimum training requirements laid down in Article 2 of Directive 85/432/EEC shall be treated as diplomas satisfying these requirements if:
they attest to training commenced before German unification,
they entitle the holder to pursue the activities of pharmacist throughout the territory of Germany under the same conditions as the qualifications awarded by the competent German authorities and referred to in Article 4 (c), and
they are accompanied by a certificate stating that their holders have effectively and lawfully been engaged in Germany in one of the activities referred to in Article 1 (2) of Directive 85/432/EEC for at least three consecutive years during the five years prior to the date of issue of the certificate, provided that such activity is regulated in the Member State in question.' Article 8 Article 6 of Directive 85/384/EEC is hereby deleted.
Article 9
Member States shall take the necessary measures to comply with this Directive by 1 July 1991. They shall forthwith inform the Commission thereof.
When Member States take these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 10
This Directive is addressed to the Member States. | [
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31990L0641 | 1990 | COUNCIL DIRECTIVE of 4 December 1990 on the operational protection of outside workers exposed to the risk of ionizing radiation during their activities in controlled areas (90/641/Euratom)
Having regard to the Treaty establishing the European Atomic Energy Community; and in particular Articles 31 and 32 thereof,
Haying regard to the proposal from the Commission, submitted following consultation with a group of persons appointed by the Scientific and Technical Committee from among scientific experts in the Member States, as laid down in Article 31 of the Treaty,
Having regard to the opinion of the European Parliament (1),
Having regard to the opinion of the Economic and Social Committee (2),
Whereas, Article 2 (b) of the Treaty provides that the Community shall establish uniform safety standards to protect the health of workers and of the general public and ensure that they are applied in accordance with the procedures laid down in Chapter III of Title II of the Treaty;
Whereas, on 2 February 1959, the Council adopted Directives laying down the basic standards for the protection of the health of workers and of the general public against the dangers arising from ionizing radiations (3), as amended by Directives 80/836/Euratom (4) and 84/467/Euratom (5);
Whereas Title VI of Directive 80/836/Euratom lays down the fundamental principles governing operational protection of exposed workers;
Whereas Article 40 (1) of that Directive provides that each Member State shall take all necessary measures to ensure the effective protection of exposed workers;
Whereas Article 20 and 23 of that Directive establish a classification of areas of work and categories of exposed workers according to the level of exposure;
Whereas the workers performing activities in a controlled area within the meaning of the said Articles 20 and 23 can belong to the personnel of the operator or be outside workers;
Whereas Article 3 of Directive 80/836/Euratom concerning the activities referred to in Article 2 of that Directive provides that they should be reported or subject to prior authorization in cases decided upon by each Member State;
Whereas outside workers are liable to be exposed to ionizing radiation in several controlled areas in succession in one and the same Member State or in different Member States; whereas these specific working conditions require an appropriate radiological monitoring system;
Whereas any radiological monitoring system for outside workers must provide protection equivalent to that offered the operator's established workers, by means of common provisions;
Whereas, pending the introduction of a uniform Community-wide system, account should also be taken of the radiological monitoring systems for outside workers which may exist in the Member States;
Whereas, to optimize the protection of outside workers, it is necessary to define clearly the obligations of outside undertakings and operators, without prejudice to the contribution that outside workers themselves have to make to their own protection;
Whereas the system for the radiological protection of outside workers also applies as far as practicable to the case of a self-employed worker with the status of outside undertaking,
TITLE I
Purpose and definitions
Article 1
The purpose of this Directive is to supplement Directive 80/836/Euratom thereby optimizing at Community level operational protection arrangements for outside workers performing activities in controlled areas.
Article 2
For the purposes of this Directive:
— ‘controlled area’ means any area subject to special rules for the purposes of protection against ionizing radiation and to which access is controlled, as specified in Article 20 of Directive 80/836/Euratom;
— ‘operator’ means any natural or legal person who under national law, is responsible for a controlled area in which an activity required to be reported under Article 3 of Directive 80/836/Euratom is carried on;
— ‘outside undertaking’ means any natural or legal person, other than the operator, including members of his staff, performing an activity of any sort in a controlled area;
— ‘outside worker’ means any worker of category A, as defined in Article 23 of Directive 80/836/Euratom, performing activities of any sort in a controlled area, whether employed temporarily or permanently by an outside undertaking, including trainees, apprentices and students within the meaning of Article 10 of that Directive, or whether he provides services as a self-employed worker;
— ‘radiological monitoring system’ means measures to apply the arrangements set out in Directive 80/836/Euratom, and in particular in Title VI thereof, during the activities of outside workers.
— ‘activities carried out by a worker’ means any service or services provided by an outside worker in a controlled area for which an operator is responsible.
TITLE II
Obligations of Member States' competent authorities
Article 3
Each Member State shall make the performance of the activities referred to in Article 2 of Directive 80/836/Euratom by outside undertakings subject to reporting or prior authorization as laid down in accordance with Title II of the aforementioned Directive, in particular Article 3 thereof.
Article 4
1. Each Member State shall ensure that the radiological monitoring system affords outside workers equivalent protection to that for workers employed on a permanent basis by the operator.
2. Pending the establishment, at Community level, of a uniform system for the radiological protection of outside workers, such as a computer network, recourse shall be had:
(a)
on a transitional basis, in accordance with the common provisions set out in Annex I, to
— a centralized national network, or
— the issuing of an individual radiological monitoring document to every outside worker, in which case the common provisions of Annex II shall also apply;
(b)
in the case of cross-frontier outside workers, and until the date of establishment of a system within the meaning of paragraph 2, to the individual document referred to in (a).
TITLE III
Obligations of outside undertakings and operators
Article 5
Outside undertakings shall, either directly or through contractual agreements with the operators, ensure the radiological protection of their workers in accordance with the relevant provisions of Titles III to VI of Directive 80/836/Euratom, and in particular:
(a)
ensure compliance with the general principles and the limitation of doses referred to in Articles 6 to 11 thereof;
(b)
provide the information and training in the field of radiation protection referred to in Article 24 thereof;
(c)
guarantee that their workers are subject to assessment of exposure and medical surveillance under the conditions laid down in Articles 26 and 28 to 38 thereof;
(d)
ensure that the radiological data of the individual exposure monitoring of each of their workers within the meaning of Annex I, part II to this Directive are kept up to date in the networks and individual documents referred to in Article 4 (2).
Article 6
1. The operator of a controlled area in which outside workers perform activities shall be responsible, either directly or through contractual agreements, for the operational aspects of their radiological protection which are directly related to the nature of the controlled area and of the activities.
2. In particular, for each outside worker performing activities in a controlled area, the operator must:
(a)
check that the worker concerned has been passed as medically fit for the activities to be assigned to him;
(b)
ensure that, in addition to the basic training in radiation protection referred to in Article 5 (1) (b), he has received specific training in connection with the characteristics of both the controlled area and the activities;
(c)
ensure that he has been issued with the necessary personal protective equipment;
(d)
also ensure that he receives individual exposure monitoring appropriate to the nature of the activities, and any operational dosimetric monitoring that may be necessary;
(e)
ensure compliance with the general principles and limitation of doses referred to in Articles 6 to 11 of Directive 80/836/Euratom;
(f)
ensure or take all appropriate steps to ensure that after every activity the radiological data of individual exposure monitoring of each outside worker within the meaning of Annex I, Part III, are recorded.
TITLE IV
Obligations of outside workers
Article 7
Every outside worker shall be obliged to make his own contribution as far as practicable towards the protection that the radiological monitoring system referred to in Article 4 is intended to afford him.
TITLE V
Final provisions
Article 8
1. Member States shall bring into force not later than 31 December 1993, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Member States shall communicate to the Commission the main provisions of domestic law which they adopt in the field governed by this Directive.
Article 9
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31990L0675 | 1990 | Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee.
Whereas the animal products or products of animal origin and plant products subject to checks intended to prevent the spread of contagious or infectious animal diseases are listed in Annex II to the Treaty;
Whereas laying down principles at Community level on the organization of veterinary checks on products coming from third countries helps to safeguard supplies and ensure market stability while also harmonizing the measures necessary to ensure the protection of animal and public health;
Whereas Article 19 of Council Directive 89/662/EEC of
11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of
the internal market (3) and Article 23 of Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the
completion of the internal market (4) provide, in particular, that the Council must lay down, before 31 December 1990, the general principles applicable to checks on imports from third countries of products covered by the said Directives;
Whereas each consignment of products from third countries must be subjected to documentary and identity checks upon entry to the Community;
Whereas principles valid throughout the Community should be fixed concerning the organization and follow-up of physical checks to be carried out by the competent veterinary authorities;
Whereas provision must be made for safeguard arrangements; whereas, in this context, the Commission must be able to act, particularly by visiting the places concerned and adopting measures appropriate to the circumstances;
Whereas, if the checking system is to function smoothly there must be an approval procedure and border inspection posts must be inspected and there should be exchanges of officials empowered to carry out checks on products coming from third countries;
Whereas the laying down of common principles at Community level is all the more necessary given that with the completion of the internal market in prospect, internal border controls are to be abolished;
Whereas the provision of certain transitional measures of limited duration appears to be necessary in order to facilitate the move over to the new checking arrangements instituted by this Directive;
Whereas the task of adopting measures for the application of this Directive should be entrusted to the Commission,
Article 1
1. Veterinary checks in respect of products from third countries entering the Community shall be carried out by the Member States in accordance with this Directive.
2. This Directive shall be without prejudice to the continued application of national veterinary requirements in respect of products, trade in which has not been the subject of Community harmonization or to the requirements resulting from Community rules where such requirements have not yet been completely harmonized at Community level.
Article 2
1. For the purposes of this Directive, the definitions contained in Article 2 of Directive 89/662/EEC and in Directive 90/425/EEC shall apply as necessary.
2. In addition:
(a) 'products` means the animal products or products of animal origin referred to in Directives 89/662/EEC and 90/425/EEC, or, in the circumstances described in Article 18:
- fresh fish landed immediately from fishing vessels,
- certain plant products,
- by-products of animal origin not covered by Annex II to the Treaty;
(b) 'documentary check` means verification of the veterinary certificates or documents accompanying a product;
(c)
'identity check` means verification, by visual inspection only, for consistency between the documents or certificates and the products and for the presence of the stamps and marks which must appear on the products in accordance with Community rules or in the case of products trade in which has not been harmonized at Community level, in accordance with the national legislation relevant to the various cases provided for by this Directive;
(d)
'physical check` means a check of the product itself, possibly including sampling and laboratory testing;
(e)
'importer` means any national or legal person who presents products for importation into the Community;
(f)
'consignment` means a quantity of products of the same type, covered by the same veterinary certificate or document, conveyed by the same means of transport and coming from the same third country or part of such country;
(g)
'border inspection post` means any inspection post located in the vicinity of the external border of one of the territories referred to in Annex I, designated and approved in accordance with Article 9;
(h)
'competent authority` means the central authority of a Member State, empowered to carry out veterinary or zootechnical checks, or any authority to which it has delegated such powers.
CHAPTER I
ORGANIZATION AND EFFECTS OF CHECKS
Article 3
The Member States shall ensure that the customs authorities do not authorize entry for home use into one of the territories referred to in Annex I unless - without prejudice to the special provisions to be adopted in accordance with Article 17 - proof has been supplied that:
i(i) in the form of the certificate for which Article 10 (1) provides, that the veterinary checks have been carried out on the products in question in accordance with Articles 4, 5, 6 and 8 to the satisfaction of the competent authority;
(ii) that the veterinary checks have been paid for, and that where relevant a deposit covering any costs provided for in Article 16 (3) has been lodged. If necessary, detailed rules for implementing this Article shall be adopted
in accordance with the procedure laid down in Article 24.
Article 4
1. Each consignment of products from a third country shall be subjected to a documentary and identity check, irrespective of the customs destination of the products, in order to verify:
- their origin,
- their subsequent destination, particularly in the case of non-harmonized products,
- that the particulars they contain afford the guarantees required by Community rules or, where products are concerned for which trade has not been harmonized at Community level, the guarantees required under national rules referred to in the various cases covered by this Directive.
2. These documentary and identity checks shall be carried out:
i(i) on entry into one of the territories referred to in Annex I at one of the border inspection posts or at any other
border crossing point a list of which - and regular updates - are to be notified by the Member States to the Commission, which shall arrange for their publication in the Official Journal of the European Communities;
(ii) by the veterinary staff of the border inspection post or - in the case of passage through a crossing point referred to in (i), by the competent authority.
Where the products undergo the documentary and identity checks at such a crossing point, they must be dispatched without delay under customs supervision to the nearest border inspection post to undergo the checks provided for in Article 8.
3. Entry into one of the territories defined in Annex I shall be prohibited where these checks show that:
(a) these products come from a territory or part of a territory of a third country which does not meet the following conditions:
i(i) in the case of products rules governing the import of which have been harmonized:
- they shall be entered on a list drawn up
in accordance with Community rules, and Directive 72/462/EEC (1) in particular, as last amended by Directive 90/425/EEC,
- imports are not prohibited pursuant to a Community decision;
(ii) in the absence of harmonized rules, in particular rules on animal health, they do not comply with the requirements provided for in the national rules applicable to the various cases covered by this Directive;
(b)
the veterinary certificate or document accompanying
the products does not meet the conditions set pursuant
to Community rules or, where rules have not been harmonized, the requirements provided for in the national rules applicable to the various cases covered by this Directive.
4. The Member States shall ensure that importers are obliged to give prior notice to the veterinary staff of the border inspection post where the products are to be submitted specifying the amount, nature and estimated time of arrival of the products.
5. Where:
- products are intended for a Member State or an area having specific requirements,
- samples have been taken but the results are not known when the means of transport leaves the border inspection post,
- imports authorized for specific cases,
are involved, information from the competent authority of the place of destination must be given:
- for products covered by Directive 90/425/EEC by means of the computerized system provided for in Article 20 of the said Directive,
- for the other products, in accordance with Article 7 (1) of Directive 89/662/EEC.
6. The detailed rules for applying paragraphs 1 to 5 shall be adopted in accordance with the procedure laid down in Article 24.
7. All expenditure incurred by the application of this Article shall be chargeable to the consignor, the consignee or their agent, without reimbursement by the Member State.
Article 5
1. For the purpose of admission to a free zone or free warehouse, as defined in Article 1 (4) (a) and (b) of Regulation (EEC) No 2504/88 (2) the competent authority shall ensure that products undergo a documentary check and verification by simple visual inspection that the documents or certificates tally with the products and, if necessary, where there are grounds for suspicion, an identity check and a physical check. Products leaving a free zone or free warehouse to be entered for home use in one of the territories referred to in Annex I will have to undergo the checks provided for in this Directive.
2. The detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 24.
Article 6
1. At the time of admission to the warehouse, the competent authority shall carry out an identity check on products to be stored under the 'customs warehousing procedure` as defined in Regulation (EEC) No 2503/88 (3) or the 'temporary storage of goods procedure` as defined
in Regulation (EEC) No 4151/88 (4) in a warehouse designated by the competent authority on the basis of guidelines to be determined under the procedure laid down in Article 24.
In addition, the competent authority shall perform the appropriate veterinary checks at the warehouse in accordance with paragraph 5.
2. The Member States shall draw up a list of the warehouses referred to in paragraph 1, specifying the type of veterinary check made on entry and exit of the products
referred to in Article 2. They shall forward the list, and any subsequent updates to the Commission.
The Commission shall publish the list of these warehouses and any subsequent updates in the Official Journal of the European Communities.
3. Products stored in a warehouse designated by a Member State which are to enter free circulation in the territories referred to in Annex I must be kept under customs supervision and before entering free circulation they must undergo the checks provided for in Article 8, or in the case of products trade in which has not been harmonized at Community level to the checks set out in Article 11.
Where a consignment is split, the products leaving the warehouse must be accompanied:
- by the certificate provided for in Article 10 (1), second indent drawn up by an official veterinarian on the basis of the certificates accompanying the consignments of products during storage and must specify the origin of the products,
- in accordance with Article 11 (4) (b) second indent by the copy of the original certificates.
4. The cost of the veterinary checks provided for in this Article shall be borne by the operator seeking customs warehousing or temporary storage.
These costs, including a deposit to cover the costs incurred as a result of any recourse to the possibilities provided for in Article 16 (3), must be paid before the products enter the warehouse.
5. Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 24.
Article 7
1. Without prejudice to measures adopted pursuant to Article 19, Member States need not apply the requirements of Article 4 (3) to products which do not satisfy either the requirements of Community rules or, in the case of products trade in which has not been the subject of Community harmonization, the relevant national rules and which are intended to be stored in a free zone provided that:
- there is a correspondence between the products or consignments and the accompanying documents,
- the products in question are subsequently forwarded
to a third country under the conditions laid down in Article 12,
- the products in question are stored in such a way as to be clearly separated from products intended to be admitted for home use to the territories referred to in Annex I.
2. Any detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 24.
Article 8
Products for which the veterinary requirements governing trade have been harmonized at Community level and which have been presented at one of the points of entry to the territory defined in Annex I must meet the following requirements:
1. If
(a) the point of entry is a border inspection post, the products must undergo without delay the checks provided for in Article 4 (1) and in point 2 below:
(b)
the point of entry is a crossing point of the kind referred to in Article 4 (2), or if the products come from a warehouse in accordance with Article 6 (3), they must be transferred without delay under customs supervision to the nearest border inspection post where the official veterinarian must:
- ensure that the checks provided for in Article 4 (1) have been satisfactorily performed,
- carry out the checks provided for in point 2.
2. The official veterinarian must:
(a)
carry out a physical check on each consignment,
on the basis of a representative sample of the consignment in order to ensure that the products are still in a fit state to be used for the purpose specified in the accompanying certificate or document;
(b)
perform the laboratory tests which have to be carried out on-the-spot;
(c)
take official samples to be examined for residues or pathogens and have them analysed as soon as possible.
The official veterinarian may be assisted in certain of these tasks by qualified staff with special training, working under his direction.
3. The detailed rules for carrying out the checks provided for in points 1 and 2 shall be laid down by the Commission under the procedure provided for in Article 24.
At the request of a Member State, accompanied by the requisite substantiating information, or acting on its own initiative, the Commission may follow the same procedure and determine that checks are to be less frequent, under certain conditions and in the light in particular of the results of previous checks, with respect to certain third countries or third country establishments offering satisfactory guarantees as regards checks at the point of origin.
The Commission will take into account the following criteria for granting derogations of this nature:
(a) the guarantees offered by the third country in question with respect to compliance with Community requirements, particularly those laid down in Directives 72/462/EEC and 90/426/EEC (1);
(b)
the health situation of animals in the third country concerned;
(c)
information on the general health situation in the country;
(d)
nature of the measures to monitor and to combat disease applied by the third country;
(e)
structures and powers of the veterinary service;
(f)
compliance with the minimum standards laid down by Community law in regard to production hygiene;
(g)
rules on the authorization of certain substances and compliance with the requirements set out in Article 7 of Directive 86/469/EEC (2);
(h)
outcome of the Community inspection visits;
(i)
outcome of the import controls carried out.
4. However, by way of derogation from point 2, for products entering a port or airport in one of the territories referred to in Annex I, the checks may be carried out in the port or airport of destination, provided that such port or airport has a border inspection post of the kind referred to in Article 2 and the products are transported by sea or air as the case may be.
Article 9
1. The border inspection posts must satisfy the requirements of this Article.
2. Border inspection posts must be:
ii(i) located in the vicinity of the point of entry into one of the territories referred to in Annex I;
i(ii) designated and approved in accordance with paragraph 3;
(iii) placed under the authority of an official veterinarian, who shall be effectively responsible for the checks. The official veterinariam may be assisted by specially trained auxiliary staff.
3. Before 31 March 1991, and once border posts have been shortlisted by national authorities, acting in conjunction with the Commission departments which will verify their compliance with the minimum requirements set out in Annex II, the Member States shall submit to the Commission the list of border inspection posts that will carry out veterinary checks on products and provide the following information:
(a) nature of the border inspection post:
- port,
- airport,
- road checkpoint,
- rail checkpoint;
(b)
nature of the products which could be checked at the border inspection post in question given the equipment and veterinary staff available, possibily mentioning any products that cannot be checked at those border inspection posts;
(c)
staff allocated to veterinary checks:
- number of official veterinarians with at least one official veterinarian on duty at all times that the border inspection post is open,
- number of specially qualified auxiliary staff or assistants;
(d)
description of the equipment and premises available given the various checks to be carried out for the following operations:
- documentary check,
- physical check,
- sampling,
- laboratory for carrying out on the spot the general tests laid down in Article 8 (2) (b),
- laboratory available for specific tests ordered by the official veterinarian;
(e)
capacity of the available premises and cold stores for storing the products pending the test results;
(f)
nature of the equipment allowing a rapid exchange of information, particularly with other border inspection posts;
(g)
procedure for handling disputes with third countries;
(h)
volume of trade (types and quantities of products passing through this border inspection post).
4. Acting in conjunction with the competent national authorities, the Commission shall inspect the border inspection posts designated in accordance with paragraph 3 with a view to ensuring that there is uniform application of the rules on veterinary checks and that the various border inspection posts in fact possess the necessary infrastructures and meet the minimum requirements laid down in Annex II.
N° later than 31 December 1991, the Commission shall submit to the Standing Veterinary Committee a report on the outcome of this inspection together with proposals taking into account the conclusions of the report with a view to establishing a Community list of border inspection posts approved in accordance with the procedure laid down in Article 24.
This report shall cover any problems encountered by certain Member States if the shortlisting referred to in the first subparagraph of paragraph 3 were to result in a large number of border inspection posts being excluded at 1 January 1992.
In accordance with the procedure laid down in Article 23, a period of up to three years may be granted to enable the border inspection posts of the Member States referred to in the previous subparagraph to comply with the requirements of this Directive and in particular those concerning equipment and infrastructure.
The Commission shall publish the list of border inspection posts, and any subsequent updates, in the Official Journal of the European Communities.
5. The Commission shall adopt any detailed rules required for implementing this Article in accordance with the procedure laid down in Article 24.
Article 10
1. Where products, trade in which has been harmonized at Community level, are not to be entered for home use in the territory of the Member State which carried out the checks referred to in Article 8, point 2, the official veterinarian responsible for the border inspection post shall:
- provide the person concerned with a copy or, if the consignment of goods is split, several authenticated copies of the original certificates relating to the goods; the period of the certificates' validity will be set in accordance with the procedure laid down in Article 24 and will depend on the nature of the product concerned,
- issue a certificate which matches the model to be devised by the Commission in accordance with the procedure laid down in Article 24 attesting that the checks referred to in Article 8, point 2, have been carried out to the satisfaction of the official veterinarian, and specifying the nature of the samples that have been taken and the results of any laboratory tests,
- keep the original certificate or certificates accompanying the goods.
2. Detailed rules for the application of paragraph 1 particularly those concerning products imported for specific purposes shall be adopted in accordance with the procedure laid down in Article 24.
3. Trade in the products referred to in Directive 89/662/EEC and allowed into the territories referred to in Annex I of this Directive shall be conducted in accordance with the rules laid down in the said Directive, in particular in Chapter II thereof.
Article 11
1. This Article shall apply in respect of the products referred to in Article 2, where the rules governing trade in which have not yet been harmonized at Community level, and which, after entering one of the territories referred to in Annex I are to be re-dispatched to another Member State which authorizes the entry of such products into its territory.
2. Each consignment of products must undergo the checks provided for in Article 4 (1) and:
(a) must either undergo the veterinary checks laid down in Article 8 at the border inspection post situated in the territory of the Member State where the products are introduced, to verify in particular whether the products concerned comply with the rules of the Member State of destination;
(b)
or, where a prior bilateral agreement has been reached between the Member State in the territory of which the point of entry to one of the territories referred to in Annex I is located and the Member State of destination, possibly together with the Member State or States of transit, on the arrangements for carrying out the checks, must be sent under customs supervision to the place of destination where veterinary checks must be carried out.
Member States shall inform the Commission and the other Member States meeting the Standing Veterinary Committee of the system adopted pursuant to this paragraph.
3. In the case referred to in paragraph 2 (a), Article 10 shall apply.
4. In the cases referred to in paragraph 2 (b):
(a) the documentary and identity checks and the physical check must be carried out at a border inspection post situated in the territory of the Member State of destination;
(b)
the competent authorities carrying out the documentary check and the identity check must;
- give the official veterinarian at the inspection post of the place of destination notice of the passage of the products, and of their probable date of arrival, in the context of the programme for developing the computerization of veterinary procedures in respect of imports (Shift project),
- specify the fact of passage on the copy or, if the consignment of products is split, copies of the original certificates,
- keep the original certificate or certificates relating to the products.
Where special conditions so warrant and where a Member State so requests, with due substantiation, the physical check may be carried out in a place other than one referred to in point (a).
Such a place shall be determined in accordance with the procedure laid down in Article 24.
5. In the cases provided for in paragraph 4, the products shall be transported under the Community transit system (external procedure) as defined in Regulation (EEC) No 2726/90 (1) in vehicles or containers sealed by the competent authority.
Trade in the products admitted after being checked in accordance with this Article shall be subject to the rules laid down in Directive 89/662/EEC.
6. If the physical check referred to in this Article shows that the product cannot be entered for home use, Article 16 shall apply.
7. Any detailed rules necessary for the application of this Article shall be adopted in accordance with the procedure laid down in Article 24.
Article 12
1. The Member States shall authorize the transport of products from one third country to another third country provided that:
(a) the party concerned supplies proof that the first third country to which products are being sent, after transit through one of the territories referred to in Annex I, undertakes under no circumstances to reject or to send back products the importation or transit of which it has authorized;
(b)
such transport has been previously authorized by the official veterinarian of the border inspection post of the Member State in the territory of which the checks provided for in Article 4 (1) are carried out;
(c)
in the case of passage through one of the territories referred to in Annex I such transport is carried out, without the goods being unloaded, under the supervision of the competent authorities in vehicles or containers sealed by the competent authorities; the only handling authorized during transport shall be that carried out at the point of entry into or exit from one of the territories referred to in Annex I.
2. All expenditure incurred pursuant to this Article shall be chargeable to the consignor, the consignee or their representative without compensation by the Member State.
3. Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 24.
Article 13
1. The competent veterinary service shall carry out an identity check and, where appropriate and without prejudice to Article 15, a physical check on products for which the customs destination is other than as provided for in Articles 5, 6, 10, 11 and 12.
2. Detailed rules for the application of this Article shall be adopted, where necessary, in accordance with the procedure laid down in Article 24.
Article 14
1. Apart from Article 15, this Chapter shall not apply to products which:
ii(i) form part of travellers' personal luggage and are intended for their personal consumption insofar as the quantity does not exceed a quantity to be defined in accordance with paragraph 3 and provided that the products come from a third country or part of a third country appearing on the list adopted in accordance with Community rules and from which importation is not prohibited;
i(ii) are sent as small packages to private persons, provided that the products are not being imported by way of trade, insofar as the quantity sent does not exceed a quantity to be defined in accordance with paragraph 3 and provided that the products come from a third country or part of a third country appearing on a list drawn up in accordance with Community rules and from which importation is not prohibited;
(iii) are intended for consumption by the crew and passengers on board means of transport operating internationally, provided that they come from a third country or part of a third country or from an establishment imports from which are not prohibited under Community rules.
Where such products or their kitchen waste are unloaded, they must be destroyed. It is not, however, necessary to destroy products when they are transferred, directly or after being placed provisionally under customs supervision, from one means of transport to another;
(iv) where quantities not exceeding a figure to be fixed in accordance with paragraph 3 are involved, have undergone heat treatment in a hermetically sealed container to a Fo value of 3,00 or more and:
(a) form part of travellers' personal luggage and are intended for their personal consumption;
(b)
are sent as small packages to private persons, provided that the products are not being imported by way of trade.
2. Paragraph 1 shall not affect the rules applicable to fresh meat and meat products in accordance with Article 1 (2) of Directive 72/462/EEC.
3. In accordance with the procedure laid down in Article 24, the Commission shall set the weight limits for the different products liable to be covered by the derogations referred to in paragraph 1.
Article 15
Without prejudice to the provisions of this Chapter, the official veterinarian or the competent authority shall, where it is suspected that veterinary legislation has not been complied with or there is doubt as to the identity of a product, carry out any veterinary checks it deems appropriate.
Article 16
1. Where the checks referred to in this Directive show the competent authority that the product does not satisfy the requirements laid down in the Community rules or national rules in matters which have not yet been harmonized at Community level, or where such checks reveal an irregularity, the competent authority, in consultation with the importer or his representative, shall decide either:
(a) to re-dispatch, within a time limit to be set by the competent national authority, the consignment outside the territories referred in Annex I where veterinary inspection and health requirements so allow.
In this case, the official veterinarian of the border post must:
- inform the other border inspection posts, in accordance with paragraph 5 that the consignment has been rejected, indicating the infringements observed;
- under arrangements to be defined by the Commission in accordance with the procedure provided for in Article 24, cancel the veterinary certificate or document accompanying the rejected consignments;
- at intervals to be determined by the Commission, supply information via the competent central authority, as to the nature and frequency of the infringements observed;
(b) to destroy the consignment in the territory of the Member State where the checks were carried out if re-dispatch is impossible.
2. Without prejudice to the options provided in Article 24 (5) third subparagraph of Directive 72/462/EEC and in Article 8 (1) (b) first indent of Directive 90/425/EEC, derogations from paragraph 1 of this Article may be made in accordance with the procedure laid down in Article 24, in particular to permit the use of products for purposes other than human consumption. In the context of such derogations and in accordance with the same procedure, conditions shall be adopted with regard to the use of the products concerned.
3. The importer or his representative shall be liable for the costs incurred in the process of re-dispatching or destroying the consignment or using the product for other purposes.
4. Detailed rules for the application of this Article shall be adopted, where necessary, in accordance with the procedure laid down in Article 24.
5. Provisions concerning the communication of information to the Member States will be adopted in the context of the programme for developing the computerization of veterinary procedures in respect of imports (Shift project).
6. The competent authorities shall, were appropriate, communicate to the Commission and the other Member States any information at their disposal in accordance with Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (1).
Article 17
The Commission, in accordance with the procedure laid down in Article 24, shall on the basis of the plans referred to in the second paragraph, adopt the rules applicable to imports into certain parts of the territories referred to in Annex I, to take account of the natural constraints specific to these territories in particular their remoteness from the mainland part of Community territory.
To that end, by 1 July 1991 at the latest, the French Republic and the Hellenic Republic will submit a plan to the Commission setting out, in the particular case of the French Overseas Departments and of certain islands and groups of islands, the nature of the checks to be carried out on imports into these regions of products originating in third countries, taking into account the natural geographical constraints specific to these territories.
These plans must specify the checks carried out to prevent products introduced into these territories being re-dispatched under any circumstances to other parts of Community territory.
Article 18
1. The Commission, in accordance with the procedure laid down in Article 24, shall draw up a list of plant products covered by Article 2 (2) (a) second indent which, in particular on account of their subsequent destination, may give rise to the risk of spreading infectious or contagious animal diseases and on that account are to be subjected to the veterinary checks laid down by this Directive, and in particular those provided for in Article 4, in order to verify the origin and planned destination of such plant products.
The following shall be adopted in accordance with the same procedure:
- the animal health conditions which third countries must comply with and the guarantees which must be offered, in particular the nature of any processing to be required in the light of their animal health situation,
- a list of the third countries which, in the light of these guarantees, may be authorized to export to the Community the plant products referred to in the first paragraph,
- any specific inspection procedures, in particular with reference to sampling which may be applied to these products, especially in the case of imports in bulk.
2. Pending the adoption of Community rules applicable to imports of these products, the Commission may, in accordance with the procedure laid down in Article 24, extend to by-products of animal origin not covered by Annex II to the Treaty the veterinary inspection rules laid down by this Directive by fixing where appropriate certain specific criteria which must be complied with when veterinary checks on these products are being carried out.
3. Fresh fish immediately landed from a vessel flying a third country flag must - before entering for home use in the territory defined in Annex I - undergo the checks laid down in respect of fish immediately landed by vessels flying the flag of a Member State.
4. In accordance with the procedure laid down in Article 24, derogations may be granted from the provisions of Article 9 and, as regards the staff responsible for carrying out the checks, those of Article 8 (2) for ports where fish is landed.
CHAPTER II
Safeguard provisions
Article 19
1. If, in the territory of a third country, a disease referred to in Directive 82/894/EEC (1), a zoonosis or other disease or phenomenon liable to present a serious threat to animal or public health, or if any other serious animal health or public health reason so warrants in particular in the light of the findings of its veterinary experts, the Commission may, acting on its own initiative or at the request of a Member State, adopt one of the following measures without delay and depending on the gravity of the situation:
- suspend imports coming from part or all of the third country concerned, and where appropriate from the transit third country,
- set special conditions in respect of imports coming from part or all of the third country concerned.
2. If one of the checks provided for in this Directive indicates that a consignment of products is likely to constitute a danger for animal or human health, the competent veterinary authority shall immediately take the following measures:
- it shall seize and destroy the consignment,
- it shall immediately inform the other border inspection posts and the Commission of the findings and of
the origin of the products, in accordance with Article 16 (5).
3. In the case provided for in paragraph 1, the Commission may take provisional protective measures in respect of products covered by Article 12.
4. Representatives of the Commission may make an immediate visit to the third country concerned.
5. As regards products the rules on imports of which have not yet been harmonized, and in the case where a Member State informs the Commission officially of the need to take safeguard measures and the Commission has not invoked the provisions of paragraphs 1 and 3 or made a referral to the Standing Veterinary Committee in accordance with paragraph 6, that Member State may take interim protective measures in respect of the products in question.
Where a Member State takes provisional protective measures in respect of a third country or third country establishment under the terms of this paragraph, it shall inform the other Member States and the Commission in accordance with Article 16 (5).
6. Without delay the Commission shall review the situation within the Standing Veterinary Committee. It may adopt the necessary decisions in accordance with the procedure laid down in Article 23, including those relating to intra-Community movements of products and to transit.
7. Decisions to modify, repeal or extend measures decided on by virtue of paragraphs 1, 2, 3 and 6 shall be taken in accordance with the procedure laid down in Article 23.
8. Detailed rules for the application of this Chapter shall be adopted, where necessary, in accordance with the procedure laid down in Article 24.
CHAPTER III
Inspection
Article 20
1. Veterinary experts from the Commission may, in conjunction with the competent national authorities and to the extent that uniform application of the requirements of this Directive renders necessary, verify that the border inspection posts approved in accordance with Article 9 satisfy the criteria listed in Annex II.
2. Veterinary experts from the Commission may, in conjunction with the competent authorities, make on-the-spot checks.
3. A Member State in whose territory an inspection is made shall provide the veterinary experts from the Commission with any assistance they may require in the performance of their tasks.
4. The Commission shall inform the Member States of the outcome of the checks.
5. Where the Commission deems that the outcome of checks so justifies, it shall review the situation within the Standing Veterinary Committee. It may adopt the necessary decisions in accordance with the procedure laid down in Article 23.
6. The Commission shall monitor developments; in the light of such developments and in accordance with the procedure laid down in Article 23, it may amend or repeal the decisions referred to in paragraph 5.
7. Detailed rules for the application of this Article shall be adopted, where necessary, in accordance with the procedure laid down in Article 24.
Article 21
1. Where, on the basis of the checks carried out at the point where the products are marketed, a competent authority of a Member State considers that this Directive is not being complied with at a border inspection post, a crossing point referred to in Article 4 (2) (i), a free port or free zone referred to in Article 5 or a free warehouse referred to in Article 6 of another Member State, it shall contact the competent central authority of that Member State without delay.
The latter shall take all the necessary measures and inform the competent authority of the first Member State of the nature of the checks made, the decisions taken and the reasons for such decisions.
If the competent authority of the first Member State believes the measures are insufficient it shall examine, with the competent authority of the Member State in question, the ways and means in which the situation could be remedied, where necessary by visiting the Member State in question.
Where the checks referred to in the first subparagraph show repeated non-compliance with this Directive, the competent authority of the Member State of destination shall inform the Commission and the competent authorities of the other Member States.
The Commission may, at the request of the competent authority of the Member State of destination or on its own initiative, and taking account of the type of infringements complained of:
- send an inspection team to the Member State in question in conjunction with the competent national authorities,
- request the competent authority to step up the checks carried out at the border inspection post, crossing point, free port, free zone or free warehouse in question.
Pending the Commission's findings, the Member State attached must, at the request of the Member State of destination, step up checks at the border inspection post, crossing point, free port, free zone or free warehouse concerned.
The Member State of destination may, for its part, intensify checks on products coming from these sources.
At the request of one of the two Member States concerned - where the irregularities are conformed by the inspection referred to in the first indent of the fourth subparagraph - the Commission must, in accordance with the procedure laid down in Article 23, take the appropriate measures. These measures must be confirmed or reviewed as soon as possible in accordance with the same procedure.
2. Rights of appeal existing under the laws in force in the Member States against decisions by the competent authorities shall not be affected by this Directive.
Decisions taken by the competent authority and the reasons for such decisions shall be notified to the operator concerned by such decisions or his respresentative.
If the operator concerned or his representative so requests, the said decisions and reasons shall be forwarded to him in writing with details of the rights of appeal which are available to him under the law in force in the Member State performing the checks of the procedure and time limits applicable.
3. The detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 24.
Article 22
1. Each Member State shall draw up a programme for the exchange of officials empowered to carry out the checks on products coming from third countries.
2. The Commission and the Member States shall coordinate the programmes referred to in paragraph 1 within the Standing Veterinary Committee.
3. Member States shall take all the measures necessary to allow implementation of the programmes resulting from the coordination referred to in paragraph 2.
4. Each year, in the Standing Veterinary Committee, the implementation of programmes shall be reviewed on the basis of reports drawn up by the Member States.
5. Member States shall take into account the experience gained in order to improve and develop the programme of exchanges.
6. A financial contribution from the Community may be granted in order to promote the efficient development of exchange programmes. Detailed rules for the Community's financial contribution and the estimated amount to be
charged to the Community budget are laid down in Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (1).
7. Detailed rules for the application of paragraphs 1, 4 and 5 shall be adopted where necessary, in accordance with the procedure laid down in Article 24.
CHAPTER IV
General provisions
Article 23
Where reference is made to the procedure provided for in this Article, the Standing Veterinary Committee set up by Decision 68/361/EEC (2) shall take decisions in accordance with the rules established in Article 17 of Directive 89/662/EEC.
Article 24
Where reference is made to the procedure defined in this Article, the Standing Veterinary Committee shall take decisions in accordance with the rules established in Article 18 of Directive 89/662/EEC.
Article 25
Annex II to this Directive may be supplemented in accordance with the procedure laid down in Article 24.
Article 26
This Directive shall be without prejudice to obligations arising from customs rules.
Article 27
Article 23 of Directive 72/462/EEC is hereby deleted.
Pending the decisions provided for in Article 4 (6), the acts taken pursuant to Article 23 of Directive 72/462/EEC shall continue to apply.
Article 28
Article 6 (1) of Directive 89/662/EEC is hereby replaced by the following:
'1. Member States shall ensure that, during the checks carried out at the places where products from a third country may be brought into the territories, defined in Annex I to Directive 90/675/EEC (*) such as ports,
airports and border inspection posts with third countries, the following measures are taken:
(a) a documentary check is made on the products` origin;
(b)
products originating in the Community are subject to the rules on checks provided for in Article 5;
(c)
products from third countries are subject to the rules laid down in Directive 90/675/EEC.
(*) OJ N° L 373, 31. 12. 1990, p. 1.'
Article 29
Article 7 of Directive 90/425/EEC is hereby replaced by the following:
'Article 7
1. Member States shall ensures that during the checks carried out at the places where animals and products referred to in Article 1 from a third country may be brought into the territories referred to in Annex I to Directive 90/675/EEC (*), such as ports, airports and border inspection posts with third countries, the following measures are taken:
(a) certificates or documents accompanying the animals and products are checked;
(b)
the products from third countries shall be subject to the rules laid down by Directive 90/675/EEC;
(c)
where animals are imported from third countries, they must be sent, under customs supervision, to border inspection posts in order that veterinary checks may be carried out.
The animals referred to in Annex A may not be given customs clearance unless those checks have shown that they comply with Community rules;
(d)
Community animals and products shall be subject to the control rules laid down in Article 5.
2. The animals must be brought directly into Community territory via one of the border inspection posts of the Member State which intends to import them and be inspected there in accordance with paragraph 1 (b).
Member States which make imports from third countries on the basis of national animal health rules shall inform the Commission and the other Member States, in particular Member States of transit, of the existence of such imports and of the requirements to which they subject such imports.
Member States of destination shall prohibit animals from being sent on from their territory unless they have remained there for the periods laid down in the specific
Community rules unless they are bound, without transit, for another Member State using the same option.
However, pending the adoption of Community rules, those animals may be brought into the territory of a Member State other than that referred to in the second subparagraph following prior agreement given by that other Member State in a general manner and, where appropriate, by a Member State of transit on the arrangements for control. Member States shall inform the Commission and the other Member States in the framework of the Standing Veterinary Committee when they are making use of this derogation and of the control arrangements agreed upon.
3. However, from 1 January 1993 and by way of derogation from paragraph 1, all animals and products transported by regular, direct means of transport linking two geographical points of the Community shall be subject to the control rules laid down in Article 5.
(*) OJ N° L 373, 31. 12. 1990, p. 1.`
Article 30
Acting in accordance with the procedure laid down in Article 24, the Commission may adopt for three years the transitional measures necessary to facilitate the move over to the new checking arrangements provided for in this Directive.
Article 31
Member States may make use of the Community financial assistance provided for in Article 38 of Directive 90/424/EEC for the implementation of this Directive.
Article 32
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1991 at the latest. They shall forthwith inform the Commission thereof.
Detailed rules for applying this Directive and in particular those of Article 8 (3) shall be adopted and the Shift system brought into force not later than 31 December 1991.
Should the date referred to in the preceding subparagraph not be met, the transitional measures provided for in Article 30 shall be taken on that date.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 33
This Directive is addressed to the Member States. | [
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"UKSI19970639"
] |
31990L0676 | 1990 | Council Directive 90/676/EEC Of 13 December 1990 amending Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products
Having regard to the Treaty establishing the European Economic Community , and in particular Article 100a thereof ,
Having regard to the proposal from the Commission (1) ,
In cooperation with the European Parliament (2) ,
Having regard to the opinion of the Economic and Social Committee (3) ,
Whereas Article 23/2 of Council Directive 81/851/EEC (4) provides that the Commission should submit to the Council a proposal containing appropriate measures leading towards the elimination of any remaining barriers to trade or to the tree movement of veterinary medicinal products not late ; than four years after the implementation of the abovementioned Directive .
Whereas the Directives on the approximation of laws relating to veterinary medicinal products must be adapted to scientific progress and improved to take account of the experience acquired since their adoption ;
Whereas it is necessary from the point of view of public health and the free movement of veterinary medicinal products for the competent authorities to have at their disposal all useful information on authorized veterinary medicinal products in the form of approved summaries of the characteristics of products ;
Whereas the approximation of laws brought about in this connection must enable a veterinary medicinal product , manufactured and placed on the market in one Member State on the basis of harmonized provisions , to be allowed into the other Member States , taking due consideration of the initial authorization , save in exceptional cases submitted for an opinion to the Committee for Veterinary Medicinal Products set up by Directive 81/851/EEC ;
Whereas the system for package inserts accompanying veterinary medicinal products should be improved ;
Whereas it is advisable to stipulate more precisely the cases in which the results of pharmacological and toxicological tests or clinical trials do not have to be provided with a view to obtaining authorization for a veterinary medicinal product which is essentially similar to an innovative product , while ensuring that innovative firms are not placed at a disadvantage , whereas , however , there are reasons of public policy for not repeating tests carried out on animal , without overriding cause ;
Whereas the guarantees of the quality of veterinary medicinal products manufactured within the Community should be maintained by requiring compliance with the principles of good manufacturing practice for medicinal products irrespective of the final destination of the products ;
Whereas the Commission should be empowered to define in detail principles of good manufacturing practice for veterinary medicinal products in close cooperation with the Committee for Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector established by Article 2b of Council Directive 81/852/EEC of 26 September 1981 on the approximation of the laws of the Member States relating to analytical , pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (5) , as amended by Directive 87/20/EEC (6) ;
Whereas measures should be taken to improve the provision of information for third countries about the conditions of use of veterinary medicinal products within the Member States and the Community ;
Whereas measures should also be taken to ensure that distributors of veterinary medicinal products are authorized by Member States and maintain adequate records ,
Article 1
Directive 81/851/EEC is hereby amended as follows :
1 . Article 1 ( 5 ) is replaced by the following :
" 5 . Member States shall take all mea ires necessary to ensure that only persons empowered under their national legislation in force possess or have under their control veterinary medicinal products or substances which may be used as veterinary medicinal products that have anabolic , anti-infectious , anti-parasitic , anti-inflammatory , hormonal or psychotropic properties .
Member States shall maintain a register of producers and dealers permitted to be in possession of active substances which may be used in the manufacture of veterinary medicinal products having the properties referred to in the first subparagraph . Such persons must maintain detailed records of all dealings in substances which may be used in the manufacture of veterinary medicinal products and keep these records available for inspection by the competent authorities for a period of at least three years .
Any amendments to be made to the list of substances referred to in the first subparagraph shall be adopted in accordance with the procedure referred to in Article 2c of Directive 81/852/EEC (*) as amended by Directive 87/20/EEC (**) .
(*) OJ No L 317 , 6 . 11 . 1981 , p. 16 .
(**) OJ No L 15 , 17 . 1 . 1987 , p. 34 .
2 . The following subparagraph is added to Article 2 ( 1 ) :
" This Directive shall apply to veterinary medicinal products used in order to produce active or passive immunity or to diagnose the state of immunity , in accordance with the provisions of Directive 90/676/EEC (***) which widens the scope of this Directive .
(***) OJ No L 373 , 31 . 12 . 1990 , p. 15 . "
3 . The second and fourth indents of Article 2 ( 2 ) are deleted .
4 . Article 4 is replaced by the following :
" Article 4
1 . No veterinary medicinal product may be placed on the market in a Member State unless authorization has previously been granted by the competent authority of that Member State .
However , where the health situation so requires , a Member State may authorize the placing on the market or administration to animals of veterinary medicinal products which have been authorized by another Member State in accordance with this Directive .
In the event of a serious disease epidemic the States may provissionally allow the use of immunological veterinary medicinal products without an authorization for placing on the market , in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use .
2 . A Member State shall not authorize the placing on the market of a veterinary medicinal product intended for administration to food-producing animals whose flesh or products are intended for human consumption , unless :
( a ) the active substance or substances capable of pharmacological action contained in the veterinary medicinal product were authorized for use in other veterinary medicinal products in the Member State concerned on the date of entry into force of Council Regulation ( EEC ) No 2377/90 of 26 June 1990 laying down a Community procedure for the fixing of maximum levels of residues of veterinary medicinal products in foodstuffs of animal origin (*) ;
( b ) the active substance or substances capable of pharmacological action is or are mentioned in Annex I , II or III to the aforementioned Regulation .
3 . No veterinary medicinal product may be administered to animals unless the authorization referred to above has been issued , except for the tests of veterinary medicinal products referred to in point 10 of Article 5 which have been accepted by the competent national authorities , following notification or authorization , in accordance with the national rules in force .
The Member States shall permit the placing on the market of foodstuffs obtained from animals treated during these tests only if they are satisfied that the foodstuffs do not contain residues which may present a risk for human health .
Without prejudice to stricter Community or national rules relating to dispensing veterinary medicinal products and to protect human and animal health , a prescription shall be required for dispensing to the public the following veterinary medicinal products ;
( a ) those products subject to official restrictions on supply or use , such as :
- the restrictions resulting from the implementation of the relevant United Nations conventions on narcotic and psychotropic substances ,
- the restrictions on the use of veterinary medicinal products resulting from Community law ;
( b ) those products in respect of which special precautions must be taken by the veterinarian in order to avoid any unnecessary risk to :
- the target species ,
- the person administering the products to the animal ,
- the consumer of foodstuffs obtained from the treated animal ,
- the environment ;
( c ) those products intended for treatments or pathological processes which require a precise prior diagnosis or the use of which may cause effects which impede or interfere with subsequent diagnostic or therapeutic measures ;
( d ) magistral formulae intended for animals .
In addition , a prescription shall be required for new veterinary medicinal products containing an active ingredient which has been authorized for use in a veterinary medicinal product for less than five years unless , having regard to the information and particulars provided by the applicant , or experience acquired in the practical use of the product , the competent authorities are satisfied that none of the criteria referred to in ( a ) to ( d ) of the third subparagraph apply .
4 . However , where there exists no authorized medicinal product for a condition , Member States may exceptionally , in particular in order to avoid causing unacceptable suffering to the animals concerned , permit the administration by a veterinarian or under his her direct personal responsibility to an animal or to a small number of animals on a particular holding (*) :
( a ) of a veterinary medicinal product authorized in the Member State concerned for use in another animal species , or for another condition in the same species ; or
( b ) if there is no product such as referred to in point ( a ) , of a medicinal product authorized for use in the Member State concerned in human beings in accordance with Directive 65/65/EEC of 26 January 1965 ; or
( c ) if there is no product such as referred to in point ( b ) and within the limits of the law of the Member State concerned , of a veterinary medicinal product prepared extemporaneously by a person authorized to do so under national legislation in accordance with the terms of a veterinary prescription ,
provided that the medicinal product , where administered to animals whose flesh or products are intended for human consumption , contains only substances to be found in a veterinary medicinal product authorized for such animals in the Member State concerned and that in the case of food-producing animals the veterinarian responsible specifies an appropriate withdrawal period to ensure that food produced from the treated animals does not contain residues harmful to consumers .
Unless the product used indicates a withdrawal period for the species concerned , the specified withdrawal period shall not be less than :
7 days : eggs ,
7 days : milk ,
28 days : meat from poultry and mammals including fat and offal ,
500 degree days : meat from fish .
The veterinarian shall keep adequate records of the date of examination of the animals , details of the owner , the number of animals treated , the diagnosis , the medicinal products prescribed , the dosages administered , the duration of treatment and the withdrawal periods recommended , and make these records available for inspection by the competent authorities for a period of at least three years . This requirement may be extended by the Member States to animals whose flesh or products are not intended for human consumption .
5 . Notwithstanding paragraph 3 , Member States shall ensure that veterinarians providing services in another Member State can take with them and administer to animals small quantities of ready-made veterinary medicinal products not exceeding daily requirements other than immunological veterinary medicinal products which are not authorized for use in the Member State in which the services are provided ( host Member State ) , providing that the following conditions are satisfied :
( a ) the authorization to place the product on the market provided for in paragraph 1 has been issued by the competent authorities of the Member State in which the veterinarian is established ;
( b ) the veterinary medicinal products are transported by the veterinarian in the original manufacturer's packaging ;
( c ) the veterinary medicinal products intended for administration to food-producing animals have the same qualitative and quantitative composition in terms of active principles as the medicinal products authorized in accordance with paragraph 1 in the host Member State ;
( d ) a veterinarian providing services in another Member State shall acquaint himself with the good veterinary practices applied in that Member State . He shall ensure that the withdrawal period specified on the labelling of the veterinary medicinal product concerned is complied with , unless he could reasonably be expected to know that a longer withdrawal period should be specified to comply with these good veterinary practices ;
( e ) the veterinarian shall not furnish any veterinary medicinal product to the owner or keeper of the animals treated in the host Member State unless this is permissible on the basis of the rules of the host Member State ; in this case he shall , however , supply only in relation to animals under his care and only the minimum quantities of veterinary medicinal product necessary to complete the treatment of animals concerned on that occasion ;
( f ) the veterinarian shall be required to keep detailed records of the animals treated , the diagnosis , the veterinary medicinal products administered , the dosage administered , the duration of treatment and the withdrawal period applied . These records shall be available for inspection by the competent authorities of the host State for a period of at least three years ;
( g ) the overall range and quantity of veterinary medicinal products carried by the veterinarian shall not exceed that generally required for the daily needs of good veterinary practice .
5 . Article 5 is replaced by the following :
" Article 5
For the purpose of obtaining the authorization for placing a product on the market provided for in Article 4 , the person responsible for placing the product on the market shall lodge an application with the competent authority of the Member State .
The following particulars and documents shall accompany such application :
1 . name or business name and permanent address or registered place of business of the person responsible for placing the product on the market and , if different , of the manufacturer or manufacturers involved and of the sites of manufacture ;
2 . name of the veterinary medicinal product ( brand name , non-proprietary name , whith or without a trademark , or name of the manufacturer or scientific name or formula , with or without a trademark , or the name of the manufacturer ) ;
3 . qualitative and quantitative particulars of all the constituents of the veterinary medicinal product , using the usual terminology but not empirical chemical formula and giving the international non-proprietary name recommended by the World Health Organization , where such a name exists ;
4 . description of the method of preparation ;
5 . therapeutic indications , contra-indications and side-effects ;
6 . dosage for the various species of animal for which the veterinary medicinal product is intended , its pharmaceutical form , method and route of administration and proposed shelf life ;
7 . if applicable , explanations of the precautionary and safety measures to be taken when the product is stored , when it is administered to animals and when waste therefrom is disposed of , together with an indication of any potential risks the medicinal product might pose to the environment and the health of humans , animals or plants ;
8 . indication of the withdrawal period necessary between the last administration of the veterinary medicinal product to animals under normal conditions of use and the production of foodstuffs from such animals in order to ensure that such foodstuffs do not contain residues in quantities in excess of the maximum limits laid down . Where necessary , the applicant shall propose and justify a tolerance level for residues which may be accepted in foodstuffs without risk for the consumer , together with routine analysis methods which could by used by the competent authorities to trace residues ;
9 . description of the control testing methods employed by the manufacturer qualitative and quantitative analysis of the constituents and the finished product , specific tests , e.g. sterility tests , test for the presence of pyrogens , for the presence of heavy metals , stability tests , biological and toxicity tests , tests on intermediate products ) ;
10 . results of :
- physico-chemical , biological or microbiological tests ,
- toxicological and pharmacological tests ,
- clinical trials .
However , and without prejudice to the law relating to the protection of industrial and commercial property :
( a ) the applicant shall not be required to provide the results of toxicological and pharmacological tests and clinical trials if he can demonstrate :
( i ) either that the veterinary medicinal product is essentially similar to a medicinal product authorized in the Member State concerned by the application and that the person responsible for placing the original veterinary medicinal product on the market has agreed that the toxicological , pharmacological or clinical references contained in the file on the original veterinary medicinal product may be used for the purpose of examining the application in question ;
( ii ) or by detailed references to the scientific literature presented in accordance with the second paragraph of Article 1 of Directive 81/852/EEC , as amended by Directive 87/20/EEC , that the constituent or constituents of the veterinary medicinal product have a well-established medicinal use , with recognized efficacy and an acceptable level of safety ;
( iii ) or that the veterinary medicinal product is essentially similar to a product which has been authorized within the Community , in accordance with Community provisions in force , for not less than six years and is marketed in the Member State for which the application is made ; this period shall be extended to 10 years in the case of high-technology medicinal products appearing on the list in Part A of the Annex to Directive 87/22/EEC (*) or of a medicinal product appearing on the list in Part B of the Annex to that Directive for which the procedure laid down in Article 2 of that Directive has been followed . Furthermore , a Member State may also extend this period to 10 years by a single Decision covering all the products marketed in its territory where it considers this necessary in the interest of public health . Member States are at liberty not to apply the abovementioned six-year period beyond the date of expiry of a patent protecting the original product ;
( b ) in the case of new veterinary medicinal products containing known constituents not hitherto used in combination for therapeutic purposes , the results of toxicological and pharmacological tests and of clinical trials relating to that combination must be provided , but it shall not be necessary to provide references relating to each individual constituent :
11 . a summary in accordance with Article 5a of the product characteristics , one or more specimens or mock-aps of the sales presentation of the veterinary medicinal product together with the package insert referred to in Article 48 ( 1 ) ;
12 . a document showing that the manufacturer is authorized in his own country to produce veterinary medicinal products ;
13 . any authorization to place the relevant veterinary medicinal product on the market which may have been obtained in another Member State or in a third country , together with a list of those countries to which an application for authorization to place the product on the market has been made and explanation of the reasons for which the Member State or third country has refused to grant authorization for the veterinary medicinal product concerned ;
14 . in the case of medicinal products containing new active ingredients which are not mentioned in Annex I , II or III to Regulation ( EEC ) No 2377/90 , a copy of the documents submitted to the Commission in accordance with Annex V to the Regulation .
(*) OJ No L 15 , 17 . 1 . 1987 , p. 38 . "
6 . The following Article is inserted :
" Article 5a
The summary of the product characteristics referred to in point 11 of point 2 of the second paragraph of Article 5 shall contain the following information :
1 . name of the veterinary medicinal product ;
2 . qualitative and quantitative composition in terms of the active ingredients and constituents of the excipient , knowledge of which is essential for proper administration of the medicinal product ; the international non-proprietary names recommended by the World Health Organization shall be used , where such names exist , or failing this , the usual non-proprietary name or chemical description ;
3 . pharmaceutical form ;
4 . pharmacological properties and , in so far as this information is useful for therapeutic purposes , pharmacokinetic particulars ;
5 . clinical particulars :
5.0 target species ,
5.1 indications for use , specifying the target species ,
5.2 contra-indications ,
5.3 undesirable effects ( frequency and seriousness ) ,
5.4 special precautions for use ,
5.5 use during pregnancy and lactation ,
5.6 interaction with other medicaments and other forms of interaction ,
5.7 posology and method of administration ,
5.8 overdose ( symptoms , emergency procedures , antidotes ) ( if necessary ) ,
5.9 special warnings for each target species ,
5.10 withdrawal periods ,
5.11 special precautions to be taken by the person administering the product to animals ;
6 . pharmaceutical particulars :
6.1 incompatibilities ( major ) ,
6.2 shelf life , when necessary after reconstitution of the product or when the container is opened for the first time ,
6.3 special precautions for storage ,
6.4 nature and contents of container ,
6.5 name or style and permanent address or registered place of business of the holder of the authorization to place the product on the market ,
6.6 special precautions for the disposal of unused product or waste materials , if any . "
7 . The following Article is inserted :
" Article 5b
When the authorization to place the product on the market , referred to in Article 4 ( 1 ) , is issued , the person responsible for placing that product on the market shall be informed , by the competent authorities of the Member States concerned , of the summary of the product characteristics as approved by them . The competent authorities shall take all necessary measures to ensure that the information given in the summary is in conformity with that accepted when the authorization to place the product on the market is issued or subsequently . "
8 . The last sentence of Article 7 is replaced by the following :
" The experts " detailed reports shall form part of the documentation which the applicam shall lodge with the competent authorities . A brief curriculum vitae of the expert shall be appended to each report . "
9 . Article 9 ( 2 ) is replaced by the following :
" 2 . may submit the medicinal product , its active principles and if necessary intermediate products or other constituent materials for testing by a State laboratory or by a laboratory designated for that purpose , in order to ensure that the testing methods employed by the manufacturer and described in the application documents , in accordance with point 9 of the second paragraph of Article 5 , are satisfactory . "
10 . In Article 9 , the following point is added :
" 4 . may require the applicant to submit substances in the quantities necessary to verify the analytical detection method proposed by the applicant in accordance with point 8 of the second paragraph of Article 5 and to put it into effect as part of routine checks to reveal the presence of residues of the veterinary medicinal products concerned " .
11 . Article 14 is replaced by the following :
" Article 14
1 . After an authorization has been issued , the person responsible for placing the product on the market must , in respect of the control methods provided for in point 9 of the second paragraph of Article 5 , take account of technical and scientific progress and introduce any changes that may be required to enable the veterinary medicinal product to be checked by means of generally accepted scientific methods . These changes must be approved by the competent authorities of the Member States concerned .
Upon request from the competent authorities , the person responsible for placing the product on the market shall also review the analytical detection methods provided for in point 8 of the second paragraph of Article 5 and propose any changes which may be necessary to take account of scientific and technical progress .
2 . The person responsible for placing the product on the market shall forthwith inform the competent authorities of any new information which might entail the amendment of the particulars and documents referred to in Article 5 or the approved summary of the product characteristics referred to in Article 5b . In particular , he shall forthwith inform the competent authorities of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is marketed and of any serious unexpected reaction occuring in the animals concerned or human beings .
3 . The person responsible for placing the product on the market shall be required to maintain records of all undesitable effects observed in animals or human beings . The records so established shall be kept for at least five years and shall be made available to the competent authorities upon request .
4 . The person responsible for placing the product on the market shall immediately inform the competent authorities , with a view to authorization , of any alteration he proposes to make to the particulars and documents referred to in Article 5 . "
12 . Article 15 is replaced by the following :
" Article 15
Authorization shall be valid for five years and shall be renewable for five year periods , on application by the holder at least three months before the date of expiry .
However , veterinary medicinal products which contain active substances included in Annex III to Regulation ( EEC ) No 2377/90 shall be authorized only for the period for which a provisional tolerance has been established and authorization may be extended if the provisional tolerance is renewed . "
13 . Chapter IV of Directive 81/851/EEC is replaced by the following :
" CHAPTER IV
Committee for Veterinary Medicinal Products
Article 16
1 . In order to facilitate the adoption of a common position by the Member States with regard to decisions on the issue of authorizations to place products on the market and to promote thereby the free movement of veterinary medicinal products , a Committee for Veterinary Medicinal Products , hereinafter referred to as " the Committee " and composed of representatives of the Member States and of the Commission , is hereby set up .
2 . The Committee's task shall be to examine , at the request of a Member State or the Commission and in accordance with Articles 17 to 22 , questions concerning the application of Articles 11 , 36 and 49 .
3 . The Committee shall draw up its own rules of procedure , which shall be published by the Commission .
The rules of procedure shall provide for , in particular :
- the publication of the names and qualifications of the members of the Committee ;
- appropriate safeguards to ensure that the members of the Committee discharge their responsabilities with complete impartiality .
The Commission shall maintain available for public inspection at its offices a register of all interests relating to the pharmaceutical industry held by members of the Committee and persons taking part in its discussions .
Article 17
1 . In order to make it easier to obtain an authorization to place a product on the market in at least two other Member States taking into due consideration an authorization issued in one Member State in accordance with Article 4 , the holder of the latter authorization may submit an application to the competent authorities of the Member States concerned together with the information and documents referred to in Articles 5 , 5a and 5b .
He shall testify to its identity with the dossier accepted by the first Member State , specifying any additions it may contain , and shall certify that all the dossiers filed as part of this procedure are identical .
2 . The holder of the authorization to place a product on the market shall notify the Committee of the application , inform it of the Member States concerned and send it a copy of the authorization . He shall also inform the Member State which granted him the initial authorization and notify it of any additions to the original dossier ; that State may require the applicant to provide it with all the particulars and documents necessary to enable it to check the identity of the dossiers filed with the dossier on which it took its decision .
3 . The holder of the authorization to place a product on the market shall notify the dates on which the dossiers were sent to the Member States concerned ; the latter shall immediately send an acknowledgement of receipt of the dossier to the Committee and to the person responsible for placing the product on the market . As soon as the Committee has noted that all the Member States concerned are in possession of the dossier , it shall forthwith inform all the Member States and the applicant of the date on which the last Member State concerned received the dossier . The Member States concerned shall either grant the authorization valid for their markets within a period of 120 days of the aforementioned date , taking into due consideration the authorization issued in accordance with paragraph 1 , or put forward a reasoned objection .
Article 18
1 . Where a Member State considers that it is unable to grant an authorization to place a product on the market , it shall forward to the Committee and to the person responsible for placing the veterinary medicinal product on the market its reasoned objection in accordance with Article 11 , within the time limits stipulated in Article 17 ( 3 ) .
2 . Upon the expiry of this period , the matter shall be referred to the Committee and the procedure referred to in Articles 21 and 22 shall be applied .
3 . On receipt of the reasoned objection referred to in paragraph 1 , the person responsible for placing the product on the market shall immediately send the Committee a copy of the particulars and documents referred to in Article 17 ( 1 ) .
Article 19
Where several applications submitted in accordance with Articles 5 and 5a have been made for authorization to place a particular veterinary medicinal product on the market , and one or more Member States have granted an authorization while one or more of the other Member States have refused it , one of the Member States concerned or the Commission or the person responsible for placing the product on the market may refer the matter to the Committee for application of the procedure provided for in Articles 21 and 22 . The Member States will be informed each time this procedure is invoked .
The same shall apply where one or more Member States have suspended or revoked an authorization to place a product on the market while one or more Member States have not done so .
In both cases , the person responsible for placing the veterinary medicinal product on the market shall be informed of any decision of the Committee to apply the procedure provided for in Article 22 .
Article 20
The competent authorities of Member States may , in specific cases where the interests of the Community are involved , refer the matter to the Committee before reaching a decision on a request for authorization to place a product on the market or on the suspension or revocation of an authorization .
Article 21
1 . The competent authorities shall draw up an assessment report and comments on the dossiers as regards the result of the analytical and toxico-pharmacological tests on , and clinical trials of , any veterinary medicinal products containing a new active substance which are the subject of a request for authorization to place the products on the market in the Member States concerned for the first time .
2 . As soon as the notification referred to in Article 17 is received , the competent authorities shall immediately communicate to the Member States concerned an assessment report , accompanied by a summary of the dossier relating to an particular veterinary medicinal product . This report shall also be communicated to the Committee where a matter is referred to the Committee pursuant to Article 18 .
The assessment report shall also be forwarded to the other Member States concerned and to the Committee as soon as a matter is referred to the Committee under the procedure laid down in Article 19 . Any assessment report so forwarded shall remain confidential .
The competent authorities shall bring the assessment report up to date as soon as it is in possession of information which is of importance for the evaluation of the balance between effectiveness and risk .
Article 22
1 . Where reference is made to the procedure described in this Article , the Committee shall consider the matter concerned and issue a reasoned opinion within 60 days of the date on which the matter was referred to it .
In the case referred to in Article 18 , the person responsible for placing the product on the market may , at his request , provide an oral or written explanation and provide additional information before the Committee issues its opinion . The Committee may extend the time limit referred to in the preceding paragraph to give the applicant time to provide an oral or written explanation .
In the case referred to in Article 19 , the person responible for placing the product on the market may be asked to provide an oral or written explanation .
2 . The Committee's opinion shall concern the grounds for the objection provided for in Article 18 ( 1 ) and the grounds on which the authorization to place the product on the market has been refused , suspended or withdrawn in the cases described in Article 19 .
The Committee shall immediately inform the Member States concerned and the person responsible for placing the product on the market of its opinion or of the opinions of its members where the latter differ .
3 . The Member State or States concerned shall decide on the action to be taken further to the Committee's opinion within 60 days of the notification referred to in paragraph 2 . They shall immediately inform the Committee of their decision .
Article 23
The Commission shall report to the Council every two years on the operation of the procedure laid down in this Chapter . "
14 . Article 24 ( 1 ) is replaced by the following :
" 1 . Member States shall take all appropriate measures to ensure that the manufacture of veterinary medicinal products is subject to the holding of an authorization . This manufacturing authorization shall likewise be required for veterinary medicinal products intended for export . "
15 . The following is added to Article 24 ( 3 ) :
" Member States shall take all appropriate measures to ensure that veterinary medicinal products brought into their territory form a third country and destined for another Member State are accompanied by a copy of the authorization referred to in paragraph 1 . "
16 . The following Article is inserted :
" Article 24a
At the request of the manufacturer of veterinary medicinal products , the exporter thereof or the authorities of an importing third country . Member States shall certify that such manufacturer is in possession of the authorization referred to in Article 24 . When issuing such certificates . Member States shall comply with the following conditions :
1 . Member States shall have regard to the prevailing administrative arrangements of the World Health Organization ;
2 . for veterinary medicinal products intended for export which are already authorized in their territory , they shall supply the summary of the product characteristics as approved in accordance with Article 5b or , in the absence thereof , an equivalent document .
Where the manufacturer is not in possession of an authorization to place the product on the market , he shall provide the authorities responsible for establishing the certificate referred to in the first paragraph with a declaration explaining why such authorization is not available . "
17 . In Article 27 , the following is added :
" ( f ) comply with the principles and the guidelines of good manufacturing practice for medicinal products laid down by Community law ;
( g ) keep detailed records of all veterinary medicinal products supplied by him , including samples , in accordance with the laws of the countries of destination . The following information at least shall be recorded in respect of each transaction , whether or not it is made for payment :
- date ,
- name of the veterinary medicinal product ,
- quantity supplied ,
- name and address of the recipient ,
- batch number .
These records shall be available for inspection by the competent authorities for a period of at least three years . "
18 . The following Article is inserted :
" Article 27a
The principles and guidelines of good manufacturing practice for veterinar , medicinal products referred to in Article 27 ( f ) shall be adopted in the form of a Directive addressed to the Member States in accordance with the procedure laid down in Article 2c of Directive 81/852/EEC , taking account of the specific nature of the veterinary medicinal product . Detailed guidelines shall be published by the Commission and revised as appropriate to take account of scientific and technical progress . "
19 . Article 34 is hereby amended as follows :
( a ) The first paragraph is replaced by the following :
" The competent authority of the Member State concerned shall ensure by means of repeated inspection that the legal requirements relating to veterinary medicinal products are complied with . "
( b ) The following paragraph is added :
" The officials representing the competent authority shall report after each of the inspections mentioned in the first paragraph on whether the manufacturer complies with the principles and guidelines of good manufacturing practice referred to in Article 27a . The inspected manufacturer shall be informed of the content of such reports . "
20 . The following Article is added :
" Article 38a
Member States shall take appropriate measures to encourage veterinarians and other professionals concerned to report to the competent authorities any undesirable effect of veterinary medicinal products . "
21 . Article 39 is replaced by the following :
" Article 39
Member States shall take all measures necessary to ensure that the competent authorities concerned communicate the appropriate information to each other , in particular regarding compliance with the requirements adopted for authorization as referred to in Article 24 ( 1 ) , or for authorization to place products on the market , for the purpose of verifying compliance with the provisions of Chapter VIII .
Upon reasoned request , Member States shall forthwith communicate the reports referred to in the third paragraph of Article 34 to the competent authorities of another Member State . If , after considering the reports , the Member State receiving the reports considers that it cannot accept the conclusions reached by the competent authority of the Member State in which the report was established , it shall inform the competent authorities concerned of its reasons and may request further information . The Member States concerned shall attempt to reach agreement . If necessary , in the event of serious differences of opinion , one of the Member States concerned shall inform the Commission . "
22 . Article 42 is replaced by the following :
" Article 42
1 . Each Member State shall take all appropriate measures to ensure that the Committee is informed immediately of decisions granting marketing authorization and of all decisions refusing or withdrawing marketing authorization , cancelling a decision refusing or withdrawing marketing authorization , prohibiting supply or withdrawing a product from the market , together with the reasons on which such decisions are based .
2 . The person responsible for placing a veterinary medicinal product on the market shall be obliged to notify the Member States forthwith of any action taken by him to suspend the marketing of a product or to withdraw a product from the market , together with the reasons for such action if it concerns the effectiveness of the veterinary medicinal product or the protection of public health . Member States shall ensure that this information is brought to the attention of the Committee .
3 . Member States shall ensure that appropriate information about actions taken pursuant to paragraphs 1 and 2 which may affect the protection of health in third countries is forthwith brought to the attention of the relevant international organizations , with a copy to the Committee . "
23 . The first paragraph to Article 43 is hereby amended as follows :
( a ) Points 1 and 2 are replaced by the following :
" 1 . Name of the veterinary medicinal product , which may be a brand name or a non-proprietary name accompanied by a trade mark or the name of the manufacturer , or a scientific name or formula , with or without a trade mark , or the name of the manufacturer .
Where the special name of a medicinal product containing only one active ingredient is a brand name , this name must be accompanied in legible characters by the international non-propriety name recommended by the World Health Organization , where such names exist or , where no such name exists , by the usual non-proprietary name .
2 . A statement of the active ingredients expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a particular volume or weight , using the international non-proprietary names recommended by the World Health Organization , where such names exist or , where no such names exist , the usual non-proprietary names . "
( b ) Points 7 and 8 are replaced by the following :
" 7 . The withdrawal period , even if nil , in the case of veterinary medicinal products administered to food-producing animals .
8 . Expiry date , in plain language . "
( c ) The following point is inserted :
" 9a . Special precautions for disposal of unused product or waste material , if any . "
24 . In Article 48 , the first paragraph is replaced by the following :
" The inclusion of a package insert in the packaging of veterinary medicinal products shall be obligatory unless all the information required by this Article can be conveyed on the container and the external packaging . Member States shall take all appropriate measures to ensure that the insert relates solely to the veterinary medicinal product with which it is included . The insert shall be in the official language or languages of the Member State in which the medicinal product is marketed . "
25 . The second paragraph of Article 48 is hereby amended as follows :
( a ) Point ( e ) is replaced by the following :
" ( e ) the withdrawal period , even if this is nil , in the case of veterinary medicinal products administered to food-producing animals ; "
( b ) The following point is added :
" ( h ) special precautions for the disposal of unused product or waste materials , if any . "
26 . The final paragraph of Article 48 is deleted .
27 . The following Chapter VIII is inserted :
" CHAPTER VIIIa
Distribution of veterinary medicinal products
Article 50a
1 . Member States shall take all appropriate measures to ensure that wholesale dealing in veterinary medicinal products is subject to the holding of an authorization and to ensure that the time taken for the procedure for granting this authorisation does not exceed 90 days from the date on which the competent authority receives the application .
For the purposes of this Directive , wholesale dealing shall include the purchase , sale , import , export , or any other commercial transaction in veterinary medicinal products , whether or not for profit , except for :
- the supply by a manufacturer of veterinary medicinal products manufactured by himself ,
- retail supples of veterinary medicinal products by persons permitted to carry out such supplies in accordance with Article 50b .
Member States may also exclude supples of small quantities of veterinary medicinal products from one retailer to another .
2 . In order to obtain the authorization referred to in paragraph 1 , the applicant shall have at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down in the Member State concerned as regards the storage and handling of products .
3 . The holder of the authorization referred to in paragraph 1 shall be required to keep detailed records . The following minimum information shall be recorded in respect of each incoming or outgoing transaction :
( a ) date ;
( b ) precise identity of the veterinary medicinal product ;
( c ) manufacturer's batch number , expiry date ;
( d ) quantity received or supplied ;
( e ) name and address of the supplier or recipient .
At least once a year a detailed audit shall be carried out to compare incoming and outgoing supplies with supplies currently held in stock , any discrepancies being recorded .
These records shall be available for inspection by the competent authorities for a period of at least three years .
4 . Member States shall take all appropriate measures to ensure that wholesalers supply veterinary medicinal products only to persons permitted to carry out retail activities in accordance with Article 50b , or to other persons who are lawfully permitted to receive veterinary medicinal products from wholesalers .
Article 50b
1 . Member States shall take all appropriate measures to ensure that the retail supply of veterinary medicinal products is conducted only by persons who are permitted to carry out such operations by the legislation of the Member State concerned .
2 . Any person permitted under the preceding paragraph to sell veterinay medicinal products shall be required to keep detailed records . The following information shall be recorded in respect of each incoming or outgoing transaction :
( a ) date ;
( b ) precise identity of the veterinary medicinal product ;
( c ) manufacturer's batch number ;
( d ) quantity received or supplied ;
( e ) name and address of the supplier or recipient ;
( f ) where relevant , name and address of the prescribing veterinarian and a copy of the prescription .
At least once a year a detailed audit shall be carried out , and incoming and outgoing products shall be reconciled with products currently held in stock , any discrepancies being recorded .
These records shall be available for inspection by the competent authorities for a period of three years .
3 . Member States may limit the scope of the record-keeping requirements referred to in paragraph 2 . However , these requirements shall always be applied in case of veterinary medicinal products intended for administration to animals whose flesh or products are intended for human consumption and which are available only on veterinary prescription or in respect of which a withdrawal period must be observed .
4 . Not later that 1 January 1992 , Member States shall communicate to the Commission a list of the veterinary medicinal products which are available without prescription . After having taken note of the communication from the Member States , the Commission shall examine whether suitable measures should be proposed for drawing up a Community list of such products .
Article 50c
Member States shall ensure that the owners or keepers of food-producing animals can provide proof of purchase , possession and administration of veterinary medicinal products containing the substances set out in Article 1 ( 5 ) ; Member States may extend the scope of this obligation to other medicinal veterinary products .
In particular , Member States may require the maintenance of a record giving at least the following information :
( a ) date ;
( b ) identity of the veterinary medicinal product ;
( c ) quantity ;
( d ) name and address of the supplier of the medicinal product ;
( e ) identification of the animals treated . "
Article 2
1 . Member States shall take the necessary measures to comply with this Directive not later than 1 January 1992 . They shall forthwith inform the Commission thereof .
2 . By way of derogation from paragraph 1 , Member States shall take the necessary measures to comply with Article 27 ( f ) and the third paragraph of Article 34 not later than two years after notification of the Directive referred to in Article 27a .
3 . Where Member States adopt the provisions referred to in paragrahs 1 and 2 , such provisions shall contain a referece to this Directive or shall be accompanied by such reference on the occasion of their official publication . The methods of making such a reference shall be laid down by the Member States .
4 . Request for authorization to place products on the market lodged from the date set out in paragraph 1 must comply with the provisions of this Directive .
5 . Within four years of the date set out in paragraph 1 , Article 1 shall , where relevant , be progressively extended to existing veterinary medicinal products .
Article 3
This Directive is addressed to the Member States . | [
"UKSI19931227"
] |
31991L0027 | 1990 | Tenth Commission Directive 91/27/EEC of 19 December 1990 amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), as last amended by Commission Directive 90/506/EEC (2), and in particular Article 13, second paragraph, indents three and four thereof,
Whereas Directive 77/93/EEC laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas the harmful organisms concerned are listed in Annex II to that Directive; whereas a list of commodities which are subject to an import ban under some conditions is also given in Annex III; whereas this Directive also specified special requirements, which are to be met in order to have better guarantees of freedom from the abovementioned harmful organisms;
Whereas the scope of the Directive should be clarified in respect of intergeneric hybrids resulting from crosses between the genera Citrus L., Fortunella Swingle and Poncirus Raf.;
Whereas therefore the relevant Annexes of Directive 77/93/EEC should be amended accordingly;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
Directive 77/93/EEC is hereby amended in accordance with the Annex hereto. Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive by 1 April 1991 at the latest. These shall make express reference to this Directive.
Member States shall immediately inform the Commission of all laws, regulations and administrative provisions adopted in implementation of this Directive.
The Commission shall inform the other Member States thereof. Article 3
This Directive is addressed to the Member States. | [
"UKSI19911777",
"UKSI19871758"
] |
31991L0071 | 1991 | Commission Directive 91/71/EEC of 16 January 1991 completing Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (1), and in particular Article 6 (4) thereof,
Whereas difference between the laws, regulations and administrative provisions of Member States on the labelling of flavourings intended for sale to the final consumer may impede the free circulation of these products and lead to unequal conditions of competition;
Whereas the main objective of any provisions on the labelling of flavourings should be the need to inform and protect the consumer;
Whereas in accordance with the procedure laid down in Article 10 of Council Directive 88/388/EEC, a draft of the measures to be taken was submitted to the Standing Committee for Foodstuffs which was unable to express an opinion; whereas under the same procedure, the Commission consequently submitted to the Council a proposal relating to the measures to be taken;
Whereas since the Council had not adopted any measures by the end of the three months it was given, the Commission must adopt the proposed measure,
Article 1
The following Article shall be added:
'Article 9a
1. Flavourings intended for sale to the final consumer may not be marketed unless their labels indicate the following obligatory information, which should be easily visible, clearly legible and indelible:
(a) either the word "flavouring" or a more specific name or description of the flavouring;
(b) either the words "for foodstuffs" or a more specific reference to the foodstuff for which the flavouring is intended;
(c) the date of minimum durability in conformity with Article 3 (1) No 4 and Article 9 of Council Directive 79/112/EEC (*);
(d) where necessary, the special conditions for storage and use;
(e) the instructions for use if omission thereof would prevent appropriate use of the flavouring;
(f) the net quantity expressed in units of mass or volume;
(g) the name or business name and address of the manufacturer or packer, or of a seller established within the Community;
(h) an indication or mark indentifying the batch in conformity with Council Directive 89/396/EEC (**);
(i) in the case of a mixture of flavouring(s) with other substances a list in descending order of weight in the mixture of:
- the flavouring or flavourings in question, in conformity with (a) above;
- the names of each of the other substances or materials or, where appropriate, their E numbers.
2. the word 'natural', or any other word having substantially the same meaning, may be used only for flavourings in which the flavouring component contains exclusively flavouring substances as defined in Article 1 (2) (b) (i) and/or flavouring preparations as defined in Article 1 (2) (c). If the sales description of the flavourings contains a reference to a foodstuff or a flavouring source, the word 'natural' or any other word having substantially the same meaning, may not be used unless the flavouring component has been isolated by appropriate physical processes, enzymatic or microbiological processes or traditional food-preparation processes solely or almost solely from the foodstuff or the flavouring source concerned.
3. The particulars required in this Article shall be given in a language easily understood by the purchaser unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such particulars from being indicated in various languages.
(*) OJ No L 33, 8. 2. 1979, p. 1.
(**) OJ No L 186, 30. 6. 1989, p. 21.' Article 2 1. Member States shall, where necessary, amend their laws, regulations and administrative provisions in such a way as to:
- permit trade in products complying with this Directive at the latest by 30 June 1992;
- prohibit trade in products not complying with this Directive with effect from1 January 1994.
They shall forthwith inform the Commission thereof.
2. All such provisions adopted by the Member States shall contain a reference to this Directive or shall be accompanied by such a reference at the time of official publication. The detailed rules on this reference shall be adopted by the Member States. Article 3
This Directive is addressed to the Member States. | [
"UKSI19921971",
"UKSI19941486"
] |
31991L0072 | 1991 | Commission Directive 91/72/EEC of 16 January 1991 amending Council Directive 79/112/EEC in respect of the designation of flavourings in the list of ingredients on the labels of foodstuffs
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer, (1) as last amended by Directive 89/395/EEC (2), and in particular the third indent of Article 6 (5) (b) thereof,
Whereas differences in national laws on the manner of designating flavourings among the ingredients listed on the labels of foodstuffs may impede free trade in these products and create unequal conditions of competition;
Whereas any provisions on the labelling of foodstuffs must be geared to the requirements of consumer information and protection;
Whereas the term 'natural' or any other word having substantially the same meaning should therefore be protected;
Whereas these terms have been defined in Article 9 (2) of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (3);
Whereas it has become necessary to extend this definition to the labelling of foodstuffs;
Whereas in accordance with the procedure laid down in Article 17 of Council Directive 79/112/EEC a draft of the measures to be taken was submitted to the Standing Committee for Foodstuffs which was unable to express an opinion; whereas under the same procedure, the Commission consequently submitted to the Council a proposal relating to the measures to be taken;
Whereas since the Council had not adopted any measures by the end of the three months it was given, the Commission must adopt the proposed measures,
Article 1
Directive 79/112/EEC shall be amended as follows:
1. The third indent of Article 6 (5) (b) shall be replaced by the following:
- 'flavourings shall be designated in accordance with Annex III to this Directive.'
2. The following Annex III shall be added:
'ANNEX III
Designation of flavourings in the list of ingredients
1. Flavourings shall be designated either by the word "flavouring(s)" or by a more specific name or description of the flavouring.
2. The word "natural" or any other word having substantially the same meaning may be used only for flavourings in which the flavouring component contains exclusively flavouring substances as defined in Article 1 (2) (b) (i) and/or flavouring preparations as defined in Article 1 (2) (c) of Directive 88/388/EEC on flavourings.
3. If the name of the flavouring contains a reference to the vegetable or animal nature or origin of the incorporated substances, the word "natural" or any other word having substantially the same meaning may not be used unless the flavouring component has been isolated by appropriate physical processes, enzymatic or microbiological processes or traditional food-preparation processes solely or almost solely from the foodstuff or the flavouring source concerned.' Article 2 1. Member States shall, where necessary, amend their laws, regulations and administrative provisions in such a way as to:
- permit trade in products complying with this Directive at the latest by 30 June 1992;
- prohibit trade in products not complying with this Directive with effect from 1 January 1994.
They shall forthwith inform the Commission thereof.
2. All such provisions adopted by the Member States shall contain a reference to this Directive or shall be accompanied by such a reference at the time of official publication. The detailed rules on this reference shall be adopted by the Member States. Article 3
This Directive is addressed to the Member States. | [
"UKSI19941486"
] |
31991L0068 | 1991 | Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the harmonious operation of the common organization of the market in ovine and caprine animals will not have the results expected of it as long as disparities between Member States as regards health conditions act as a restraint on intra-Community trade;
Whereas in order to encourage such trade it is advisable to remove those disparities and introduce Community-wide rules on the marketing of ovine and caprine animals in such trade; whereas that objective will also contribute to the completion of the single market;
Whereas in order to be eligible for intra-Community trade, ovine and caprine animals should meet certain animal health requirements designed to avoid the spread of infectious or contagious diseases;
Whereas the animal health requirements applicable should vary depending on the purpose for which the animals are traded;
Whereas the health situation for ovine and caprine animals is not the same throughout the territory of the Community; whereas reference should therefore be made to 'regions` as defined in Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (4), as last amended by Directive 90/425/EEC (5), when dealing with parts of that territory;
Whereas there must be no barriers to trade between regions in which the animal health conditions are equivalent;
Whereas provision should be made for allowing the Commission to approve certain additional requirements
in the light of the progress made by a Member State
in eradicating certain diseases, provided that those requirements in no case exceed those applied nationally by the Member State concerned;
Whereas in order to avoid the spread of infectious or contagious diseases, conditions should be laid down as regards the transportation of the animals to their place of destination;
Whereas in order to ensure that the requirements applicable are complied with, provision should be made for introducing a health certificate which would be issued by an official veterinarian and which would accompany ovine and caprine animals until they reach their place of destination;
Whereas reference should be made, as regards the organization and follow up of the checks to be carried out by the Member States and as regards the protective measures to be introduced, to the general rules laid down in Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view of the completion of the internal market;
Whereas provision should be made for allowing the Commission to conduct its own checks;
Whereas a procedure should be introduced which provides for close and efficient cooperation between the Member States and the Commission within the Standing Veterinary Committee,
Article 1
This Directive defines the animal health conditions governing intra-Community trade in ovine and caprine animals.
Article 2
For the purposes of this Directive, the definitions laid down in Article 2 of Directive 64/432/EEC shall apply, with the addition of the following:
1. ovine or caprine animals for slaughter means animals of the ovine or caprine species intended to be taken either
directly or via an approved market or assembly centre to a slaughterhouse in order to be slaughtered there under the conditions laid down in Article 6 of Directive 64/432/EEC;
2. ovine or caprine animals for breeding and fattening: ovine and caprine animals other than those mentioned in point 1 intended to be transported to the place of destination, either directly or via an approved market or assembly centre;
3. holding: a holding as defined in Article 2 (4) of Directive 90/425/EEC;
4. officially brucellosis-free ovine or caprine holding means a holding which satisfies the conditions laid down in heading I, Chapter 1 of Annex A;
5. brucellosis-free ovine or caprine holding means a holding which satisfies the conditions laid down in Chapter 2 of Annex A;
6. trade means trade between Member States within the meaning of Article 9 (2) of the Treaty;
7. compulsorily notifiable disease means a disease as listed under Sections I and II of Annex B, the suspicion or appearance of which must be notified to the competent authorities of the Member State;
8. official veterinarian means a veterinarian designated
by the competent central authority of the Member State;
9. approved market or assembly centre means any place, other than the holding, where ovine or caprine animals are sold, bought and/or assembled or loaded, and which complies with Article 3 (7) of Directive 64/432/EEC and Article 5 (1) (b) (i) of Directive 90/425/EEC for approved markets or assembly centres;
10. region means a part of the territory of the Community as defined in Article 2 (o) of Directive 64/432/EEC.
Article 3
1. Ovine and caprine animals for slaughter may be the subject of trade only if they fulfil the conditions laid down in Article 4.
2. Ovine and caprine animals for breeding and fattening may be the subject of trade only if they fulfil the conditions laid down in Articles 4, 5 and 6, without prejudice to any additional guarantees which may be required pursuant to Articles 7 and 8.
However, the competent authorities of Member States of destination may grant general or limited derogations in respect of movement of ovine and caprine animals for breeding and fattening, intended solely for temporary pasturing near internal borders of the Community. Member States making use of such derogation shall inform the Commission of the content of the derogations granted.
Article 4
1. Ovine and caprine animals:
(a) must be identified and registered in accordance
with the requirements of Article 3 (1) (c) of Directive 90/425/EEC; the time limit for notifying the national systems for identifying and registering ovine and caprine animals begins running from the date of adoption of this Directive;
(b) must show no clinical sign of disease when inspected by an official veterinarian, such inspection must take place during the 48 hours preceding the loading of the ovine and caprine animals;
(c) must not come from a holding which is the subject of a prohibition on health grounds and must not have been in contact with animals from such a holding, it being understood that:
i(i) such prohibition shall be linked to an outbreak of any of the following diseases to which the animals are susceptible:
- brucellosis,
- rabies,
- anthrax,
(ii) after slaughter of the last animal suffering from or susceptible to one of the above diseases, the period of prohibition must be at least:
- 42 days in a case of brucellosis,
- 30 days in a case of rabies,
- 15 days in a case of anthrax,
and must not come from a holding or have been in contact with animals from a holding situated in an established protection zone and from which animals are forbidden to leave pursuant to Article 3 (2) (b) (ii) of Directive 64/432/EEC;
(d) must not be the subject of animal health restrictions applied pursuant to Council Directive 85/511/EEC of 18 November 1985 introducing Community measures for the control of foot-and-mouth disease (1), as amended by Directive 90/423/EEC (2).
Furthermore, the provisions of Article 4a of Directive 64/432/EEC shall apply.
2. Member States shall also ensure that the following are not the subject of trade:
- ovine and caprine animals which might have to be slaughtered under a national programme for the eradication of diseases not referred to in Annex C to Directive 90/425/EEC or in Chapter I of Annex B to this Directive,
- ovine and caprine animals which cannot be marketed on their own territory for health or animal health reasons justified by Article 36 of the Treaty.
3. Ovine and caprine animals must also:
- either have been born and reared since birth in the territory of the Community,
- or, if they have been imported, come from a third country included on the list drawn up in accordance with Article 3 of Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat and meat products from third countries (1), as last amended by Directive 90/425/EEC, and
i(i) either meet the animal health conditions laid
down in accordance with Article 8 of Directive 72/462/EEC,
(ii) or, in the absence of such conditions, be subject
to compliance with the conditions laid down in
Article 7 (2) second, third and fourth subparagraphs of Directive 90/425/EEC.
Article 5
Without prejudice to the additional guarantees that may be required in accordance with Articles 7 and 8, ovine and caprine animals for breeding and fattening must, in addition to the conditions laid down in Article 4, meet - in order
to be introduced onto an officially brucellosis-free or brucellosis-free ovine or caprine holding - respectively the requirements of Chapter I.D or Chapter 2.D of Annex A.
Article 6
Without prejudice to the additional guarantees that may
be required in accordance with Articles 7 and 8, animals
for breeding must furthermore meet the following requirements:
(a) They must have been obtained from a holding and must only have been in contact with animals from such a holding:
ii(i) in which the following diseases have not been clinically diagnosed:
- in the previous six months, contagious agalactia of sheep (Mycoplasma agalactiae) or contagious agalactia of goats (Mycoplasma agalactiae, M. capricolum, M. Mycoïdes var. mycoïdes 'large colony`,
- in the previous 12 months, paratuberculosis or caseous lymphadenitis,
- in the previous three years, pulmonary adenomatosis, Maedi Visna or caprine viral arthritis/encephalitis. However, this period
shall be reduced to 12 months if the animals infected with Maedi Visna or caprine
viral arthritis/encephalitis have been
slaughtered and the remaining animals have reacted negatively to two tests recognized under the procedure set out in Article 15,
or which, without prejudice to compliance with the requirements for other diseases, provides, for one or more of the abovementioned diseases, within the framework of a programme approved in accordance with Articles 7 and 8, health guarantees which are equivalent for the said disease or diseases;
i(ii) where no facts suggesting that the requirements of point (i) have not been met, have been brought
to the attention of the official veterinarian responsible for issuing the health certificate;
(iii) whose owner states that he has no knowledge of any such facts and, moreover, states in writing
that the animal or animals intended for intra-Community trade comply with the criteria laid down in point (i);
(b) in addition, with regard to scrapie, they must:
ii(i) come from a holding satisfying the following requirements:
- the holding is subject to official checks in accordance with Article 3 (1) (b) of Directive 90/425/EEC,
- the animals must be marked,
- no case of scrapie has been confirmed for at least two years,
- checking by sampling must be carried out at slaughter on old ewes, intended for culling coming from that holding, except where that holding is situated in a region or a Member State benefiting from conditions to be adopted in accordance with Article 8,
- female animals may only be introduced into that holding if they come from a holding which complies with the same requirements;
i(ii) have been continuously kept on a holding or holdings complying with the requirements laid down in (i) since birth or for the last two years;
(iii) when they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in Articles 7 or 8, satisfy the guarantees furnished pursuant to those Articles;
(c) whith regard to contagious epidydimitis (B. ovis), non castrated rams, for breeding, must:
- come from a holding where no case of contagious epidydimitis (B. ovis) has been diagnosed in the preceding 12 months,
- have been continuously kept on that holding for 60 days prior to dispatch,
- in the 30 days prior to dispatch have undergone, with negative results, a serological test carried out in accordance with Annex D or satisfy equivalent health guarantees to be recognized under the procedure laid down in Article 15;
(d) the certificate corresponding to Model III of Annex E states that these requirements have been met.
Article 7
1. A Member State which has a compulsory or voluntary national control programme or a national monitoring programme for one of the infectious or contagious diseases referred to in Annex B, Sections II and III for all or part of
its territory may submit the said programme to the Commission, outlining in particular:
- the distribution of the disease in the Member State,
- the reasons for the programme, taking into consideration the importance of the disease and the programme's likely benefit in relation to its cost,
- the geographical area in which the programme will be implemented,
- the various status categories to be applied to the holdings, the standards which must be attained in each category, and the test procedures to be used,
- the programme monitoring procedures,
- the action to be taken if, for any reason, a holding loses its status,
- the measures to be taken if the results of the tests carried out in accordance with the provisions of the programme are positive.
2. The Commission shall examine the programmes presented by the Member States. Programmes as referred to in paragraph 1 may be approved, in compliance with the criteria laid down in paragraph 1, in accordance with the procedure provided for in Article 15. According to the same procedure, the additional guarantees, general or limited, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months
after approval of the programmes. Such guarantees must not exceed those which the Member State implements nationally.
3. Programmes submitted by Member States may be amended or supplemented in accordance with the procedure laid down in Article 15. Amendments or additions to programmes which have already been approved or to guarantees which have been defined in accordance with paragraph 2 may be approved under the same procedure.
4. Programmes approved in accordance with this Article shall benefit from the Community funding provided for in
Article 24 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (1) for the diseases and under the conditions laid down therein.
Article 8
1. Where a Member State considers that its territory or part of its territory is free from one of the diseases listed in Annex B, Sections II and III to which ovine and caprine animals are susceptible, it shall present to the Commission appropriate supporting documentation, setting out in particular:
- the nature of the disease and the history of its occurrence in its territory,
- the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation and on the fact that the disease must by law be notified to the competent authorities,
- the period over which the surveillance was carried out,
- where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by such prohibition,
- the arrangements for verifying the absence of the disease.
2. The Commission shall examine supporting documentation submitted by Member States. The additional guarantees, general or limited, which may be required in intra-Community trade shall be defined in accordance with the procedure laid down in Article 15. Such guarantees must not exceed those which the Member State implements nationally. Where supporting documentation is submitted before 1 January 1992, decisions on additional guarantees shall be taken before 1 July 1992.
3. The Member State concerned shall notify the Commission of any change in the supporting documentation specified in paragraph 1 which relate to the disease. The guarantees defined as laid down in paragraph 2 may, in the light of such notification, be amended or withdrawn in accordance with the procedure laid down in Article 15.
Article 9
In trade between Member States, ovine and caprine animals must, during transportation to the place of destination, be accompanied by a health certificate, signed by an official veterinarian, which conforms to Annex E (Models I, II and III), and which must be drawn up, on the day of the inspection provided for in Article 4 (1) (b), in at least one of the official languages of the Member State of destination, and be valid for 10 days. The certificate shall consist of a single sheet.
Article 10
1. The rules laid down in Directive 90/425/EEC shall apply, in particular to checks at origin, to the organization
of, and follow-up to, the checks to be carried out by the Member State of destination, and to the protective measures to be implemented.
2. In Annex A, heading I of Directive 90/425/EEC the following reference is added:
'Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals,
OJ N° L 46, 19. 2. 1991, p. 19.`
3. In Annex B point A of Directive 90/425/EEC, the first indent is deleted.
Article 11
1. Veterinary experts from the Commission may, to the extent necessary to ensure uniform application of this Directive and in cooperation with the competent national authorities, carry out on-the-spot inspections. The Member State on whose territory inspections are carried out shall afford all necessary aid to the experts in the accomplishment of their task. The Commission shall inform the Member States of the outcome of such inspections.
2. General arrangements for the application of this Article shall be adopted in accordance with the procedure laid down in Article 15.
The rules applicable in respect of the inspections referred to in this Article shall be laid down in accordance with the same procedure.
Article 12
Member States which implement an alternative control system providing guarantees equivalent to those laid down in Article 5 and Article 6 (a) and (c) as regards movements within their territory of ovine and caprine animals may grant one another derogations from the inspection provided for under Article 4 (1) (b) and the obligation to produce a certificate provided for under Article 9 on a reciprocal basis. They shall notify the Commission thereof.
Article 13
The provisions of this Directive shall be re-examined before 1 January 1993 in the framework of the proposals relating to the completion of the internal market, on which the Council will decide by a qualified majority.
Article 14
Annex A shall be amended by the Council, acting by a qualified majority on a proposal from the Commission.
Annexes B, C and D shall be amended in accordance with the procedure laid down in Article 15.
Article 15
1. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter without delay to the Standing Veterinary Committee set up by Decision 68/361/EEC (1) hereinafter referred to as the 'Committee`, either on his own initiative or at the request of the representative of a Member State.
2. (a) The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
(b) If the measures envisaged are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority.
Article 16
The Commission may, in accordance with the procedure laid down in Article 15, adopt - for a period of three years - the transitional measures necessary to facilitate the changeover to the new arrangements provided for in this Directive.
Article 17
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with:
i(i) Articles 7 and 8 of this Directive two months after the notification date thereof, it being understood that the
corresponding national provisions shall continue to apply until the approval of the programmes and in the absence of programmes until the date referred to in (ii);
(ii) the other provisions of this Directive not later than 31 December 1992.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 18
This Directive is addressed to the Member States. | [
"UKSI19911155",
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"UKSI19923159"
] |
31991L0069 | 1991 | Council Directive 91/69/EEC of 28 January 1991 amending Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine animals and swine, fresh meat or meat products from third countries, in order to include ovine and caprine animals
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43
thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Directive 91/68/EEC (4) lays down the veterinary inspection conditions governing intra-Community trade in ovine and caprine animals; whereas in order to enable that trade to develop harmoniously, common rules should be laid down as regards imports from third countries;
Whereas Directive 72/462/EEC (5), as last amended by Directive 90/425/EEC (6), lays down health and veterinary inspection requirements for the importation of bovine animals and swine, fresh meat or meat products from third countries;
Whereas ovine and caprine animals belong, together with bovine animals, to the Bovidae family and are susceptible to the same diseases; whereas the Community's livestock is thus exposed to a similar risk in respect of imports from third countries; whereas reference should therefore generally be made to the rules laid down in Directive 72/462/EEC, subject to any changes which may be required in the light of the special characteristics of ovine and caprine animals,
Article 1 Directive 72/462/EEC is hereby amended as follows:
1. The title is replaced by the following:
'Council Directive of 12 December 1972 on health and veterinary inspection problems upon importation of
bovine, ovine and caprine animals and swine, fresh meat or meat products from third countries'.
2. In Article 1 (1), the following is added as a second indent:
'- domestic ovine or caprine animals for breeding, rearing, fattening or slaughter.'
3.
In Article 2, the first paragraph is replaced by the following:
'For the purposes of this Directive, the definitions given in Articles 2 of Directives 64/432/EEC, 64/433/EEC and in Council Directive 72/461/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries (7), all these Directives, as last amended by Directive 89/662/EEC (8), by Council Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-Community trade in meat products (9) as last amended by Directive 89/662/EEC, and by Directive 91/68/EEC (10), shall apply as necessary.(11)
OJ No L 302, 31. 12. 1972, p. 24.
(12) OJ No L 395, 30. 12. 1989, p. 13.
(13) OJ No L 26, 31. 1. 1977, p. 85.
(14) OJ No L 46, 19. 2. 1991, p. 19.'
4.
In the third paragraph of Article 2, point (c) is replaced by the following:
'(c) "third country" means a country in which Directives 64/432/EEC, 64/433/EEC, 77/99/EEC and 91/68/EEC do not apply;'.
5.
In the third paragraph of Article 2, point (e) is replaced by the following:
'(e)
"holding" means an officially supervised agricultural, industrial or commercial undertaking situated in the territory of a third country, on which bovine animals or swine, for breeding, production or slaughter, or ovine or caprine animals for breeding, rearing, fattening or slaughter are regularly kept or bred;'.
6.
In Article 3 (1) and the first subparagraph of Article 3 (2), 'bovine animals and swine' is replaced by 'bovine, ovine and caprine animals and swine'.
7.
The title of Chapter II is replaced by the following:
'CHAPTER II:
Importation of bovine, ovine and caprine animals and swine'.
8.
The first indent of Article 6 (a) is supplemented by the following:
'Peste des petits ruminants, Epizootic Haemorrhagic Disease, sheep pox, goat pox and Rift Valley Fever'.
9.
Article 8
(2) is replaced by the following:
'2. It may be decided, in accordance with the procedure laid down in Article 29, that authorizations are to be confined to particular species, to bovine animals or swine for slaughter, breeding or production, to ovine or caprine animals for breeding, rearing, fattening or slaughter or to animals intended for particular purposes, or that all necessary animal health measures are to be applied after importation.
In the case of animals for breeding, rearing, production or fattening, requirements imposed pursuant to this paragraph may vary from one Member State to another in order to take account of the special provisions for the benefit of Member States in the framework of intra-Community trade.'
10. Article 8 (3) is replaced by the following:
'3. With regard to fixing animal health conditions in accordance with paragraph 1:
- the standards laid down in Annex A of Directive 64/432/EEC shall apply as the reference basis for bovine tuberculosis, bovine and swine brucellosis,
- the standards laid down in Articles 4, 5 and 6, or pursuant to Article 7 or 8, and those contained in Annex A of Directive 91/68/EEC, shall apply as the reference basis for the disease to which ovine and caprine animals are susceptible.
It may be decided, in accordance with the procedure laid down in Article 29, on a case-by-case basis to derogate from those standards where the third country concerned provides similar animal health guarantees; in that case, animal health conditions at least equivalent to those in the said Articles or Annex shall be laid down in accordance with the same procedure in order to permit the entry of such animals into Community herds or flocks.'
11. In Article 9, 'bovine animals and swine' is replaced by 'bovine, ovine and caprine animals and swine'.
12. In Article 10, in the introductory part of the first paragraph, 'bovine animals and swine' is replaced by 'bovine, ovine and caprine animals and swine'.
13. In the first paragraph of Article 10, point (a) is replaced by the following:
'(a) six months in the case of bovine animals or swine, for breeding or production and of ovine or caprine animals for rearing, breeding or fattening;'
14. The first subparagraph of Article 11 (1) is replaced by the following:
'1. Member States shall not authorize the importation of bovine, ovine or caprine animals or swine unless a certificate drawn up by an official veterinarian of the exporting third country is produced.'
15. Article 11 (1) (d) is replaced by the following:
'(d)
attest that the bovine, ovine or caprine animals or swine meet the requirements of this Directive and those laid down pursuant to this Directive with regard to importation from third countries;'
16. Article 12 (1) is replaced by the following:
'1. Member States shall ensure that domestic bovine, ovine and caprine animals and domestic swine are subjected immediately upon arrival in the territory of the Community to an animal health inspection carried out by an official veterinarian, whatever the customs procedure under which they were declared.'
17. The introductory sentence of Article 12 (2) is replaced by the following:
'2. Member States shall ensure that bovine, ovine and caprine animals and swine are prohibited from movement within the Community if, during the inspection prescribed in paragraph 1, it is found that:'
18. The third indent of Article 12 (2) is replaced by the following:
'- the conditions laid down in this Directive and contained in Annexes A to D to Directive 64/432/EEC and those laid down in Article 4, 5 or 6, or fixed pursuant to Article 7 or 8, and those contained in Annex A to Directive 91/68/EEC have not been complied with by the exporting third country;'
19. Article 12 (4) is replaced by the following:
'4. The certificate accompanying bovine, ovine or caprine animals and swine on importation must, following the animal health inspection (import inspection), include a statement clearly indicating whether the animals have been admitted or refused entry.'
20. Article 27 (1) (a) is replaced by the following:
'(a)
the frontier inspection posts for the importation of bovine, ovine or caprine animals and swine;' Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1992. They shall notify the Commission thereof forthwith.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 3
This Directive is addressed to the Member States. | [
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"UKSI19923159"
] |
31991L0067 | 1991 | Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas aquaculture animals and products are included in the list in Annex II to the Treaty;
Whereas the breeding and rearing of aquaculture animals, and the placing on the market of aquaculture animals and products constitutes a source of income for persons working in the fisheries sector;
Whereas, in order to ensure the rational development of this sector and to increase productivity, health rules for this sector must be laid down at Community level;
Whereas in this context it is necessary to contribute to the completion of the internal market, avoiding the spread of infectious or contagious diseases;
Whereas the animal health situation for aquaculture animals is not the same throughout the territory of the Community; whereas reference must therefore be made to the concept of zones when dealing with parts of the territory concerned;
Whereas criteria and procedures should be laid down for the grant, maintenance, suspension, restoration and withdrawal of approval of such zones;
Whereas reference should also be made to the concept of farms enjoying a specific animal health status;
Whereas criteria and procedures should be laid down for the grant, maintenance, suspension, restoration and withdrawal of approval of such farms;
Whereas it is necessary to set Community requirements applicable to imports of aquaculture animals and products from third countries; whereas these requirements must provide for adequate protective measures;
Whereas a Community inspection system should be established in order to verify compliance with this Directive;
Whereas scientific studies should be undertaken so as to be able to supplement in the future the rules laid down by this Directive;
Whereas provision should be made for a procedure establishing close and efficient cooperation between the Commission and the Member States within the Standing Veterinary Committee,
CHAPTER 1 General provisions
Article 1
This Directive defines the animal health conditions governing the placing on the market of aquaculture animals and products.
This Directive shall apply without prejudice to Community or national provisions on the conservation of species.
Article 2
For the purposes of this Directive:
1. 'aquaculture animals` means live fish, crustaceans or molluscs coming from a farm, including those from the wild intended for a farm;
2. 'aquaculture products` means products derived from aquaculture animals, whether intended for farming, such as eggs and gametes, or for human consumption;
3. 'fish, crustaceans or molluscs` means any fish, crustacean or mollusc at any stage of development;
4. 'farm` means any establishment or, in general,
any geographically defined installation in which aquaculture animals are reared or kept with a view to their being placed on the market;
5. 'approved farm` means a farm complying, as the case may be, with the requirements of Annex C I, II or III, and approved as such in accordance with Article 6;
6. 'approved zone` means a zone complying, as the case may be, with the provisions of Annex B I, II or III, and approved as such in accordance with Article 5;
7. 'approved laboratory` means a laboratory located in
the territory of a Member State, designated by the competent authority, under its responsibility, to carry out the diagnostic tests provided for in this Directive;
8. 'official service` means the veterinary service or any other service of equivalent level designated by the competent authority of the Member State or third country and responsible for carrying out the controls provided for in this Directive;
9. 'health inspection` means a visit by an official service or services for the purpose of conducting health checks on a farm or zone;
10. 'placing on the market` means holding or displaying for sale, offering for sale, selling, delivering, transferring or any other form of placing on the market in the Community, with the exception of retail sale.
CHAPTER 2 Placing on the market of Community aquaculture animals and products
Article 3
1. The placing on the market of aquaculture animals shall be subject to the following general requirements:
(a) they must show no clinical signs of disease on the day of loading;
(b) they must not be intended for destruction or slaughter under a scheme for the eradication of a disease listed in Annex A;
(c) they must not come from a farm which is subject to a prohibition for animal health reasons and must not have been in contact with animals from such a farm.
2. Aquaculture products being placed on the market for breeding purposes (eggs and gametes) must originate from animals which satisfy the requirements laid down in paragraph 1.
3. Aquaculture products being placed on the market for human consumption must originate from animals which satisfy the requirements laid down in paragraph 1 (a).
Article 4
Aquaculture animals must be dispatched in the shortest possible period to the place of destination, using means
of transport that have been cleaned and, if necessary, disinfected in advance with a disinfectant that is officially authorized in the Member State of dispatch.
If water is used in overland transport, the vehicles shall be designed in such a way that water cannot escape from the vehicle during transport. Transport shall be carried out in such a way as to safeguard effectively the health of the animals, in particular by changing the water. Changes of water must be carried out in places complying with the requirements of Annex D. A list of these places and any subsequent amendments thereto must be notified by each Member State to the Commission, which shall forward that information to the other Member States.
Article 5
1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, of lists I and II, the status of approved zone, Member States shall submit to the Commission:
- all appropriate justifications concerning the conditions laid down, as the case may be, in Annex B under I B, II B or III B,
- the national rules ensuring compliance with the conditions laid down, as the case may be, in Annex B under I C, II C or III C.
2. The Commission shall scrutinize the information referred to in paragraph 1. The Commission may, in accordance with the procedure laid down in Article 26, approve or restore approval of zones, having regard to that information.
If, in accordance with Annex B under I D 5, II D or III D 5, the approval of a zone is withdrawn by the official service, the Commission shall revoke the decision concerning its approval.
3. The Commission shall draw up the list of approved zones. It shall amend this list in order to take account of new approvals or withdrawal of approvals. The Commission shall forward the list and any amendments thereto to the Member States.
Article 6
1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, of lists I and II, the status of approved farm situated in a non-approved zone, Member States shall submit to the Commission:
- all appropriate justifications concerning the conditions set out, as the case may be, in Annex C under I A, II A or III A,
- the national rules ensuring compliance with the conditions set out in Annex C under I B, II B or III B.
2. On receipt of the file relating to the request for approval or re-approval of a farm in a non-approved zone, the Commission shall have a month within which to examine that file. That examination shall be carried out in the light
of the information mentioned in paragraph 1 and, where appropriate, of on-site inspections undertaken in accordance with the provisions set out in Article 17.
Should that examination lead to favorable conclusions, the Commission shall forward such conclusions to the Member States. The Member States shall have a period of two weeks within which to make known their remarks.
After expiry of that period, if no remarks have been made or if the Member States' remarks are not contrary to the Commission's conclusions, the Commission shall approve or re-approve the farm.
Should there exist major differences between the Commission's conclusions and the Member States' remarks, or should the Commission, after examining the file, consider that the approval or re-approval ought not be granted, the Commission shall have two months within which to refer the matter to the Standing Veterinary Committee and obtain its opinion. In that case, the approval or re-approval shall be granted in accordance with the procedure laid down in Article 26.
If in accordance with Annex C under I C, II C or III C, the approval of a farm is withdrawn by the official service, the Commission shall revoke the approval decision.
3. The Commission shall draw up the list of approved farms. It shall amend that list in order to take account of new approvals or withdrawal of approvals. The Commission shall forward the list and any amendments thereto to the Member States.
Article 7
1. The placing on the market of live fish belonging to the susceptible species referred to in Annex A, column 2 of lists I and II, their eggs or gametes, shall be subject to the following additional guarantees:
(a) where they are to be introduced into an approved zone, they must, in accordance with Article 11, be accompanied by a movement document corresponding to the model set out in Annex E, Chapter 1 or 2, certifying that they come from an approved zone or
an approved farm. Pending the outcome of the review provided for in Article 28, additional guarantees to be met for the introduction into an approved zone of
fish coming from an approved farm situated in a non-approved zone shall be fixed in accordance with the procedure laid down in Article 26. Pending that decision, national rules shall continue to apply subject to compliance with the general provisions of the Treaty;
(b) where they are to be introduced into a farm which, although not situated in an approved zone, fulfils the conditions set out in Annex C I, they must in accordance with Article 11, be accompanied by a movement document corresponding to the model set out in Annex E, Chapter 1 or 2, certifying that they come respectively from an approved zone or from a farm of the same health status as the farm of destination.
2. The Commission may, in accordance with the procedure laid down in Article 26, adapt or delete the additional guarantees referred to in paragraph 1, depending on the evolution of the animal health situation in the Community, in particular in order to take account of the results of the eradication measures for the disease referred to in Annex A, column 1 of list I.
Article 8
1. The placing on the market of live molluscs referred to in Annex A, column 2 of lists I and II, shall be subject to the following additional guarantees:
(a) if they are to be relaid in an approved coastal zone, they must, in accordance with Article 11, be accompanied by a movement document corresponding to the model set out in Annex E, Chapter 3 or 4, certifying that they come from an approved coastal zone or from an approved farm in a non-approved coastal zone, as the case may be;
(b) if they are to be relaid in a farm which although not situated in an approved coastal zone fulfils the conditions set out in Annex C III, they must, in
accordance with Article 11, be accompanied by a movement document corresponding to the model set out in Annex E, Chapter 3 or 4, certifying that they come from an approved coastal zone or from a farm of the same health status as the farm of destination.
2. The Commission may, in accordance with the procedure laid down in Article 26, adapt or delete the additional guarantees referred to in paragraph 1, on the basis of the animal health situation existing in the Community.
Article 9
The placing on the market in an approved zone of aquaculture animals and products for human consumption originating in a non-approved zone shall be subject to the following requirements:
1. Fish susceptible to the diseases referred to in Annex A, column 1 of lists I and II, must be slaughtered and eviscerated prior to dispatch.
However, pending the outcome of the review provided for in Article 28, the obligation to eviscerate shall not be required, if the fish come from an approved farm in a non-approved zone. Derogations from this principle may be adopted under the procedure provided for in Article 26.
Pending that decision, national rules shall continue to apply subject to compliance with the general provisions of the Treaty.
2. Live molluscs susceptible to the diseases referred to in Annex A, column 1 of lists I and II must be delivered either for direct human consumption or to the preserving industry and shall not be relaid unless:
- they originate in an approved farm in a non-approved coastal zone, or
- they are temporarily immersed in storage ponds or purification centres which are specially equipped and approved for that purpose by the competent authority and include in particular a system for the treatment and disinfection of residual water. The conditions for such approval will be determined by the Commission in accordance with the procedure laid down in Article 26.
3. The Commission shall, in accordance with the procedure provided for in Article 26, take, if necessary, appropriate measures to ensure uniform compliance with this Article.
Article 10
1. Where a Member State draws up or has drawn up a programme designed to enable it subsequently to initiate the procedures provided for in Article 5 (1) and Article 6 (1), it shall submit its programme to the Commission specifying in particular:
- the geographical zone and farm or farms concerned,
- the measures to be taken by the official services to ensure that the programme is properly carried out,
- the procedures followed by the approved laboratories, their number and location,
- the prevalence of the disease or diseases listed in Annex A, column 1 of lists I and II,
- the measures laid down to combat these diseases where detected.
2. The Commission shall scrutinize the programmes submitted by the Member States. The programmes shall be approved in accordance with the procedure laid down in Article 26. After the adoption of the programmes, the introduction of aquaculture animals and products into zones or farms covered by the programmes shall be subject to the rules set out in Articles 7 and 8.
3. Programmes submitted by Member States may be amended or supplemented in accordance with the procedure laid down in Article 26. Under the same procedure the Commission may approve an amendment or addition to a programme which has been approved or to guarantees provided for by the rules referred to in paragraph 2.
Article 11
1. The movement documents referred to in Articles 7 and 8 must be drawn up by the official service at the place of origin within 48 hours before loading, in the official language or languages of the place of destination. They must be drawn up on a single sheet of paper, be made out for a single consignee. They shall be valid for 10 days.
2. Each consignment of aquaculture animals and products must be clearly identified in order to be able to trace back to the farm of origin, and to verify where appropriate the correlation of the animals or products with the information contained in the accompanying movement document. This information may figure directly on the container or on a label fixed to it or on the movement document.
Article 12
1. Where a Member State draws up or has drawn up a voluntary or compulsory control programme for one of the diseases referred to in Annex A, column 1 of list III, it shall submit the programme to the Commission, outlining in particular:
- the distribution of the disease in the Member States,
- the justification of the programme, taking into account, the importance of the disease and the programme's likely benefit in relation to its cost,
- the geographical area in which the programme will be implemented,
- the status of farms to be established, and the standards which must be achieved by the farms in each category, including test procedures,
- the rules applicable for entry of animals of a lower health status into the farm,
- the action to be taken if, for any reason, a farm loses its status,
- the procedures under which the programme is to be monitored.
2. The Commission shall scrutinize the programme presented by the Member States. These programmes may be approved in accordance with the procedure laid down in Article 26. The additional guarantees, general or specific, which may be required for the introduction of aquaculture animals and products into officially checked zones or farms shall be defined in accordance with the same procedure.
3. Programmes submitted by Member States may be amended or supplemented in accordance with the procedure laid down in Article 26. Under the same procedure, the Commission may approve an amendment or addition to a programme which has been approved or to guarantees which have been defined in accordance with paragraph 2.
Article 13
1. Where a Member State considers that its territory or part of its territory is free from one of the diseases listed in Annex A, column 1 of list III, it shall submit to the Commission appropriate justifications, setting out in particular:
- the name of the disease and the previous history of its ocurrence in that Member State,
- the results of surveillance testing based on serological, virological, microbiological or pathological findings, as appropriate, and on the fact that the disease is compulsorily notifiable to the competent authorities,
- the period over which the surveillance was carried out,
- the control arrangements for verifying that the area concerned remains free from the disease.
2. The Commission shall examine such justifications. The additional guarantees, general or specific, which may be required for the introduction of aquaculture animals and products into certain areas or farms shall be defined in accordance with the procedure provided for in Article 26.
3. The Member State concerned shall notify the Commission of any change in the particulars specified in
paragraph 1 which relate to the disease. The guarantees defined as laid down in paragraph 2 may, in the light of such notification, be amended or withdrawn in accordance with the procedure provided for in Article 27.
Article 14
1. Without prejudice to the requirements for diseases referred to in Annex A, column 1 of list III, established in accordance with the procedure laid down in Articles 12 and 13, the placing on the market of live farmed fish (molluscs or crustaceans) not belonging to the susceptible species referred to in Annex A, column 2 of lists I and II as well as their eggs and gametes shall be subject to the following additional requirements:
(a) where they are to be introduced into an approved zone, they must be accompanied in accordance with Article 11 by a movement document corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from a zone of the same health status, from an approved farm
in a non-approved zone or from a farm which may be situated in a non-approved zone on condition that such a farm contains no fish, molluscs or crustaceans belonging to the susceptible species referred to in Annex A, column 2 of lists I and II and is not connected with a watercourse or with coastal or estuarial waters.
However, pending the outcome of the review provided for in Article 28, Member States may, under the procedure laid down in Article 26, request a derogation from the preceding subparagraph, in particular so as to prohibit the introduction into an approved zone of fish, molluscs or crustaceans referred to in this paragraph, originating from an approved farm in a non-approved zone or from a farm which may be situated in a non-approved zone on condition that such a farm contains no fish, molluscs or crustaceans belonging to the susceptible species referred to in Annex A, column 2 of lists I and II and is not connected with a watercourse or with coastal or estuarial waters. In order to ensure uniform compliance with that provision, appropriate conditions and measures shall be fixed under the same procedure. Pending those decisions, national rules shall continue to apply subject to compliance with the general provisions of the Treaty;
(b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must be accompanied in accordance with Article 11 by a movement document corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone, from a farm of the same health status or from a farm which may be situated in a non-approved zone, on condition that such a farm contains no fish, molluscs or crustaceans belonging to the susceptible species referred to in Annex A, column 2 of lists I and II and is not connected with a watercourse or with coastal or estuarial waters.
2. Without prejudice to the requirements for diseases referred to in Annex A, column 1 of list III established in accordance with the procedure laid down in Articles 12 and 13, the placing on the market of wild fish, molluscs or crustaceans, their eggs or gametes, shall be subject to the following additional requirements:
(a) where they are to be introduced into an approved zone, they must be accompanied in accordance with Article 11 by a movement document corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from a zone of the same health status;
(b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must be accompanied in accordance with Article 11 by a movement document corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone.
Article 15
Sampling plans and diagnostic methods to be applied for the detection and confirmation of the presence of the diseases referred to in Annex A, column 1, shall be established in accordance with the procedure laid down in Article 26. These sampling plans must take account of the presence of wild fish, crustaceans and molluscs in the aquatic environment.
Article 16
1. The rules laid down in Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (1) as regards aquaculture products for human consumption and Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (2) as regards aquaculture animals and products placed on the market shall apply, in particular as regards the organization of and the action to be taken following
the inspections to be carried out by the Member State of destination, and the protective measures to be implemented.
2. Directive 89/662/EEC is amended as follows:
(a) in Annex A, the following indent is added:
'- Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products (OJ N° L 46, 19. 2. 1991, p. 1)`;
'- aquaculture products intended for human consumption.`
3. In Annex A, point I, of Directive 90/425/EEC the following reference is added:
'Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products (OJ N° L 46, 19. 2. 1991, p. 1)`.
Article 17
1. Commission veterinary experts may, where it is necessary for the uniform application of this Directive, carry out on-site inspections in conjunction with the competent authorities. The Member State in whose territory an inspection is carried out shall provide the experts with all the assistance necessary to complete their task. The Commission shall notify the Member States of the outcome of such inspections.
2. General provisions for the application of this Article shall be adopted in accordance with the procedure laid down in Article 26.
The rules to be followed during the inspection provided for in this Article shall be drawn up in accordance with the same procedure.
CHAPTER 3 Rules governing imports from third countries
Article 18
Aquaculture animals and products imported into the Community shall satisfy the conditions laid down in Articles 19, 20 and 21.
Article 19
1. Aquaculture animals and products must come from third countries or parts thereof appearing on a list drawn up by the Commission in accordance with the procedure laid down in Article 26. That list may be supplemented or amended in accordance with the same procedure.
2. In deciding whether a third country or part thereof may appear on the list referred to in paragraph 1, particular account shall be taken of:
(a) the state of health of the aquaculture animals, particular attention being paid to exotic diseases and the environmental health situation in the third country which might endanger the health of livestock in the Member States;
(b) the regularity and rapidity of the information supplied by the country relating to the existence of infectious or contagious diseases of aquaculture animals in its territory, in particular those diseases mentioned in list B of the International Office of Epizootics;
(c) the rules of the third country on the prevention and control of diseases of aquaculture animals;
(d) the structure of the official services in the third country and their powers;
(e) the organization and implementation of measures to prevent and control infectious or contagious diseases of aquaculture animals;
(f) assurances which the third country may provide concerning the rules laid down in this Directive.
3. The list referred to in paragraph 1 and all amendments thereto shall be published in the Official Journal of the European Communities.
Article 20
1. For each third country, aquaculture animals and products shall satisfy the health conditions adopted in accordance with the procedure laid down in Article 26.
2. Depending on the animal health situation in the third country concerned, the conditions referred to in paragraph 1 may include in particular:
- restriction to imports from a part of the third country,
- restriction to certain species at any stage of development,
- the prescription of a treatment to be applied to the products, such as the disinfection of eggs,
- prescription of the use to which these animals or products are to be put,
- the measures to apply following importation, such as quarantine or the disinfection of eggs.
Article 21
1. Aquaculture animals and products shall be accompanied by a certificate drawn up by the official services of the exporting third country. This certificate must:
(a) be issued on the day of loading of the consignment for dispatch to the Member State of destination;
(b) accompany the consignment in the original;
(c) attest that the aquaculture animals and certain fishery products meet the requirements of this Directive and those laid down pursuant thereto with regard to importation from the third country;
(d) be valid for 10 days;
(e) consist of a single sheet of paper;
(f) be made out for a single consignee.
2. The certificate referred to in paragraph 1 must comply with a model established in accordance with the procedure laid down in Article 26.
Article 22
Inspections shall be carried out on the spot by veterinary experts of the Member States and the Commission to verify whether the provisions of this Directive, and in particular Articles 19 and 20 thereof, are being applied in practice.
The experts from the Member States who are to be entrusted with the task of carrying out these inspections shall be appointed by the Commission, acting on proposals from the Member States.
Those inspections shall be made on behalf of the Community, which shall bear the expenditure incurred in this connection.
The frequency of and the procedures for these inspections shall be determined in accordance with the procedure laid down in Article 26.
Article 23
1. The general rules and principles applicable during inspections of aquaculture products imported from third countries shall be those laid down in Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (1).
2. The general rules and principles applicable during inspections of live aquaculture animals imported from third countries shall be those laid down by Article 7 of Directive 90/425/EEC.
Article 24
If an infectious or contagious disease of aquaculture animals, likely to endanger the health of livestock in a Member State, breaks out or spreads in a third country or if any other animal health reason so justifies, the rules, procedures and measures laid down in Article 17 of Directive 90/425/EEC shall apply.
CHAPTER 4 Final provisions
Article 25
Annexes C and E may be amended in accordance with the procedure laid down in Article 26.
(;) OJ N° L 373, 31. 12. 1990, p. 1.
Annexes A, B and C shall be amended only by the Council acting by a qualified majority on a proposal from the Commission, with a view in particular to adapting them to technological progress.
Article 26
1. Where the procedure laid down in this Article is to be followed, the Chairman shall refer the matter without delay to the Standing Veterinary Committee set up by Decision 68/361/EEC (1), hereinafter referred to as 'the Committee`, either on his own initiative or at the request of the representative of a Member State.
2. (a) The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of
decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority.
Article 27
1. Where the procedure laid down in this Article is to be followed, the Chairman shall without delay, refer the matter to the Committee, either on his own initiative or at the request of the representative of a Member State.
2. (a) The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within two days. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the
Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of 15 days from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority.
Article 28
Before 1 July 1992, in respect of the list of diseases set out in Annex A, and before 1 January 1997, in respect of the health status of approved farms in a non-approved zone, the Council shall, on the basis of a report from the Commission on the experience gained, prepared following an opinion from the Scientific Veterinary Committee and accompanied by any proposals, on which it will decide by a qualified majority, review the provisions of this Directive and in particular those concerning the marketing of live fish coming from approved farms in non-approved zones.
Article 29
1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 30
This Directive is addressed to the Member States. | [
"UKSI19932255",
"UKSI19923300"
] |
31991L0126 | 1991 | Commission Directive 91/126/EEC of 13 February 1991 amending the Annexes to Council Directive 74/63/EEC on undesirable substances and products in animal nutrition
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (1), as last amended by Directive 87/519/EEC (2), and in particular Article 7 thereof,
Whereas Directive 74/63/EEC provides for a regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge;
Whereas there are grounds to reduce the level of aflatoxin in certain straight feedingstuffs and complementary feedingstuffs for dairy cattle, with the aim of limiting as far as possible the transfer of this mycotoxin in milk;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,
Article 1
The Annex I to Directive 74/63/EEC is hereby amended as set out in the Annex hereto.
Article 2
Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with Article 1 by 30 November 1991. They shall immediately inform the Commission thereof.
When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19912840"
] |
31991L0103 | 1991 | Commission Directive 91/103/EEC of 18 February 1991 amending Directive 86/547/EEC amending Annex III B to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), as last amended by Directive 91/27/EEC (2), and in particular the first indent of Article 13 (2) thereof,
Having regard to the requests made by Greece, Spain, France, Ireland, Italy, Portugal and the United Kingdom,
Whereas Directive 77/93/EEC laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas those measures include measures to be taken by Member States in respect of plants, plant products and other objects coming from third countries;
Whereas certain Member States have stricter measures in respect of those plants and plant products;
Whereas those stricter measures include, in the requesting Member States, certain restrictions applicable to certain products originating in a third country;
Whereas, by Commission Directive 86/547/EEC (3), Annex III B to Directive 77/93/EEC was amended so that the Member States concerned could also impose the relevant prohibitions where the products concerned, originating in a third country, come from other Member States; whereas these amendments were only interim protective measures lasting for a period of three years;
Whereas that period was allotted for the Commission to study these protective measures in relation to the plant health situation existing in the various third countries concerned, in order to arrive, at the end of the period, at more permanent provisions;
Whereas it appeared impossible to finalize this study within the period originally alloted by Directive 86/547/EEC;
Whereas Commission 90/80/EEC (4) extended the said period for one year;
Whereas it appears impossible to finalize this study despite the one year extension to the original period; whereas this period should be further extended accordingly;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
In Article 3 of Directive 86/547/EEC, '31 December 1990' is hereby replaced by '31 December 1991'. Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 3
This Directive is addressed to the Member States. | [
"UKSI19911777"
] |
31991L0102 | 1991 | Commission Directive 91/102/EEC of 18 February 1991 amending Directive 88/272/EEC amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (1), as last amended by Directive 91/27/EEC (2), and in particular the second indent of Article 13 (2) thereof,
Having regard to the requests made by Greece, Spain, France, Ireland, Italy, Portugal and the United Kingdom,
Whereas Directive 77/93/EEC laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas those measures include measures to be taken by Member States in respect of plants, plant products and other objects coming from third countries;
Whereas certain Member States have stricter measures in respect of those plants and plant products;
Whereas those stricter measures include, in the requesting Member States, certain restrictions applicable to certain products originating in a third country;
Whereas, by Commission Directive 88/272/EEC (3), the Annexes to Directive 77/93/EEC were amended so that the Member States concerned could also impose the relevant restrictions where the products concerned, originating in a third country, come from other Member States; whereas these amendments were only interim protective measures for a limited period to enable the Commission to study the phytosanitary basis of the restrictions case by case;
Whereas it appeared impossible to finalize this study within the limited period originally allowed by Directive 88/272/EEC;
Whereas Commission Directive 90/113/EEC (4) extended the originally limited period for one year;
Whereas it appears impossible to finalize this study despite the one year extension on the original period; whereas this period should be further extended accordingly;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
In Article 4 of Directive 88/272/EEC, '31 December 1990', is replaced by '31 December 1991'. Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 3
This Directive is addressed to the Member States. | [
"UKSI19911777"
] |
31991L0325 | 1991 | Commission Directive 91/325/EEC of 1 March 1991 adapting to technical progress for the twelfth time Council Directive 67/548/EEC on the approximation of the laws, Regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Directive 79/831/EEC (2), and in particular Articles 19, 20 and 21 thereof,
Whereas Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (3) stipulates, in
Article 16
(3), that on the date that that Directive enters into force, Council Directive 73/173/EEC of 4 June 1973 on the approximation of Member States' laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations (solvents) (4) and Council Directive 77/728/EEC of 7 November 1977 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of paints, varnishes, printing inks, adhesives and similar products (5) shall cease to apply; whereas it is necessary to introduce into Annex I to Directive 67/548/EEC the concentration limits for the substances previously determined in Directives 73/173/EEC and 77/728/EEC;
Whereas it is necessary to alter the format of Annex I to Directive 67/548/EEC in order to include concentration limits set on the basis of the toxicological properties of dangerous substances;
Whereas Germany and Denmark have requested a change in the labelling of a number of substances and notified the Commission accordingly under Article 23 of Directive 67/548/EEC;
Whereas examination of the list of dangerous substances in the said Annex I has shown that this list needs to be adapted in the light of present scientific and technical knowledge;
Whereas it is necessary for certain substances already classified as either 'very toxic' or 'extremely flammable' to change the symbol in accordance with the classification; whereas the gases hydrogen, methane and ethane should be classified as 'extremely flammable' with the appropriate label and risk phrase;
Whereas the Spanish and Portuguese languages have not yet been included in all cases in the text of Annexes I, II, III, IV and VI;
Whereas Annex III to Directive 67/548/EEC contains a list of phrases indicating the nature of the special risks attributed to dangerous substances; whereas it is necessary to introduce new combined phrases indicating danger to health after long term exposure and for the risk of cancer following inhalation; whereas substances and preparations assigned the risk-phrase R49 'may cause cancer by inhalation' constitute a sub-group of those substances and preparations assigned R45 'may cause cancer'; whereas it is also necessary to introduce new risk phrases indicating the danger for the environment;
Whereas Annex IV to Directive 67/548/EEC contains a list of the phrases indicating the safety advice concerning dangerous substances; whereas it is necessary to introduce new safety advice phrases related to the dangers for the environment;
Whereas Annex VI to Directive 67/548/EEC contains a guide to classification and labelling of dangerous substances and preparations; whereas it is necessary to amend this guide to include criteria for substances dangerous for the environment, new criteria for long-term health effects and changes resulting from Directive 88/379/EEC;
Whereas Directive 67/548/EEC has been adapted to technical progress more than 10 times and to a substantial extent; whereas for the sake of clarity the various amendments to Annexes I, II, III, IV and VI should be assembled in a single text;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations,
Article 1
Directive 67/548/EEC is hereby amended as follows:
1. Annex I is replaced by Annex I to this Directive.
2. Annex II is replaced by Annex II to this Directive.
3. Annex III is replaced by Annex III to this Directive.
4. Annex IV is replaced by Annex IV to this Directive.
5. Parts II B, C and D of Annex VI are replaced by Annex V to this Directive.
Article 2
1. Not later than 8 June 1991, the Member States shall implement the laws, regulations and administrative provisions necessary to comply with Annexes I, II, III and IV, and Chapters 1, 2, 3, 4, 6.1, 7, 8, and 9 of Annex V to this Directive.
2. Not later than 1 July 1992, the Member States shall implement the laws, regulations and administrative provisions necessary to comply with Chapters 5 and 6.2 of Annex V to this Directive.
3. Member States shall immediately inform the Commission thereof.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19931746",
"UKSI19933050"
] |
31991L0155 | 1991 | Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (1), as last amended by Commission Directive 90/492/EEC (2), and in particular Article 10 (2) thereof,
Whereas the labelling required by Directive 88/379/EEC constitutes a basic source of information for users of dangerous preparations by giving them a clear, concise indication of the potential dangers; whereas that labelling needs to be supplemented by a more detailed information system for industrial users;
Whereas Article 10 of Directive 88/379/EEC provides for the setting up of an information system in the form of safety data sheets relating to dangerous preparations; whereas, moreover, this Article specifies that such information is principally intended for industrial users and must enable them to take the measures necessary to ensure the protection of health and safety at the workplace;
Whereas there are close links between Directive 88/379/EEC and Council Directive 67/548/EEC of 27 June 1967, on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (3), as last amended by Directive 79/831/EEC (4); whereas it is therefore desirable to establish a system of safety data sheets which is applicable to both dangerous substances and dangerous preparations; whereas the implementing provisions for dangerous substances will be laid down in due course;
Whereas the advisory committee on safety, hygiene and health protection at the workplace set up by Council Decision 74/325/EEC (5), as last amended by the Act of Accession of Spain and Portugal, has been consulted;
Whereas the provisions of this Directive are in accordance with the opinion of the committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations,
Article 1
1. Any person established within the Community who is responsible for placing a dangerous substance or preparation on the market, whether the manufacturer, importer or distributor, shall supply the recipient who is an industrial user of the substance or preparation with a safety date sheet containing the information set out in Article 3.
2. The information shall be provided free of charge at the latest when the substance or preparation is first supplied and thereafter following any revision due to any significant new information regarding safety and protection of health and the environment.
The new dated version, identified as 'Revision: . . . (date)' shall be provided free of charge to all former recipients who received the substance or preparation within the preceding 12 months.
3. The safety data sheet need not be supplied where dangerous substances or preparations offered or sold to the general public are furnished with sufficient information to enable users to take the necessary measures as regards the protection of health and safety. However, a safety data sheet must be supplied at the request of an industrial user.
Article 2
Member States may make the placing of dangerous substances or preparations on the market in their territory subject to the use of their official language or languages for the compilation of the safety data sheet referred to in Article 1.
Article 3
The safety data sheet referred to in Article 1 shall contain the following obligatory headings:
1. identification of the substance/preparation and of the company/undertaking;
2. composition/information on ingredients;
3. hazards identification;
4. first-aid measures;
5. fire-fighting measures;
6. accidental release measures;
7. handling and storage;
8. exposure controls/personal protection;
9. physical and chemical properties;
10. stability and reactivity;
11. toxicological information;
12. ecological information;
13. disposal considerations;
14. transport information;
15. regulatory information;
16. other information.
It shall be incumbent on the person responsible for placing the substance or preparation on the market to supply the information specified under these headings. This information shall be compiled in accordance with the Explanatory Notes in the Annex. The safety data sheet shall be dated.
Article 4
The implementing provisions for dangerous substances will be laid down later.
Article 5
1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 30 May 1991 at the latest and shall forthwith inform the Commission thereof.
2. These provisions shall take effect from 8 June 1991.
However, existing information systems of the safety data sheet type in use in some Member States may continue to be used until 30 June 1993.
3. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 6
This Directive is addressed to the Member States. | [
"UKSI19933050"
] |
31991L0326 | 1991 | Commission Directive 91/326/EEC of 5 March 1991 adapting to technical progress for the thirteenth time Council Directive 67/548/EEC on the approximation of laws, Regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Directive 79/631/EEC (2), and in particular Article 19 thereof,
Whereas Annex I to Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling procedures in respect of each substance; whereas it is necessary to add to this list a number of substances notified to the Commission in accordance with the Directive;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directive for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations,
Article 1
Directive 67/548/EEC is hereby amended as follows:
1. The following paragraph is added at the end of the section 'Numbering of entries in Annex I' of the foreword to Annex I:
'For dangerous substances notified under Article 6 of Directive 67/548/EEC, the EEC number used in Annex I is the same number as in the European list of notified substances (Elincs). This numbering is a seven-digit system of the type ×××.×××.× which starts at 400.010.9.'
2. The substances listed in the Annex are added to Annex I.
Article 2
Not later than 1 July 1992, the Member States shall implement the laws, regulations and administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19931746",
"UKSI19933050"
] |
31991L0244 | 1991 | Commission Directive 91/244/EEC of 6 March 1991 amending Council Directive 79/409/EEC on the conservation of wild birds
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds (1), as last amended by Directive 86/122/EEC (2), and in particular Articles 6, 15, 16 and 17 thereof,
Whereas Annex I to Directive 79/409/EEC should be amended to take account of the latest information on the situation of bird species;
Whereas, in order to prevent commercial interests from exerting possible harmful pressure on exploitation levels, the marketing of the subspecies Anser albifrons flavirostris and Tetrao tetrix tetrix should be banned;
Whereas the marketing of the species and subspecies Anser albifrons albifrons, Aythya marila, Melanitta nigra, Anas clypeata, Tetrao tetrix britannicus, Pluvialis apricaria, Lymnocryptes minimus, Gallinago gallinago and Scolopax rusticola should be brought within the scope of Article 6 (3) of Directive 79/409/EEC;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the adaptation of Directive 79/409/EEC to technical and scientific progress,
Article 1
Annexes I and III to Directive 79/409/EEC are hereby replaced by the Annexes to this Directive. Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive at the latest by 31 July 1992. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3
This Directive is addressed to the Member States. | [
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31991L0156 | 1991 | Council Directive 91/156/EEC of 18 March 1991 amending Directive 75/442/EEC on waste
Having regard to the Treaty establishing the European Economic Community, and in particular Article 103s thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Par- liament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Directive 75/442/EEC (4) established a set of Community rules on waste disposal; whereas these must be amended to take account of experience gained in the implementation of this Directive by the Member States; whereas the amendments take as a base a high level of environmental protection;
Whereas the Council undertook to amend Directive 75/442/EEC in its resolution of 7 May 1990 on waste policy (5);
Whereas common terminology and a definition of waste are needed in order to improve the efficiency of waste management in the Community;
Whereas, in order to achieve a high level of environmental protection, the Memeber States must, in addition to taking action to ensure the responsible removal and recovery of waste, take measures to restrict the production of waste particularly by promoting clean technologies and products which can be recycled and re-used, taking into consideration existing or potential market opportunities for recovered waste;
Whereas, moreover, any disparity between Member States' laws on waste disposal and recovery can affect the quality of the environment and interfere which the functioning of the internal market;
Whereas it is desirable to encourage the recycling of waste and re-use of waste as raw materials; whereas it may be necessary to adopt specific rules for re-usable waste;
Whereas it is important for the Community as a whole to become self-sufficient in waste disposal and it is desirable for Member States individually to aim at such self-sufficiency;
Whereas, in order to achieve the abovementioned objectives, waste management plans should be drawn up in the Member States;
Whereas movements of waste should be reduced and whereas Member States may take the necessary measures to that end in their management plans;
Whereas, to ensure a high level of protection and effective control, it is necessary to provide for authorization and inspection of undertakings which carry out waste disposal and recovery;
Whereas, subject to certain conditions, and provided that they comply with environmental protection requirements, some establishments which process their waste themselves or carry out waste recovery may be exempted from permit requirements; whereas such establishments should be subject to registration;
Whereas, in order that waste can be monitored from its production to its final disposal, other undertakings involved with waste, such as waste collectors, carriers and brokers should also be subject to authorization or registration and appropriate inspection;
Whereas a committee should be set up to assist the Commission in implementing this Directive and adapting it to scientific and technical progress,
Article 1
Directive 75/442/EEC is hereby amended as follows:
1. Articles 1 to 12 are replaced by the following:
'Article 1
For the purposes of this Directive:
(a) "waste" shall mean any substance or object in the categories set out in Annex I which the holder discards or intends or is required to discard.
The Commission, acting in accordance with the procedure laid down in Article 18, will draw up, not later than 1 April 1993, a list of wastes belonging to the categories listed in Annex I. This list will be periodically reviewed and, if necessary, revised by the same procedure;
(b) "producer" shall mean anyone whose activities produce waste ("original producer") and/or anyone who carries out pre-processing, mixing or other operations resulting in a change in the nature or composition of this waste;
(c) "holder" shall mean the producer of the waste or the natural or legal person who is in possession of it;
(d) "management" shall mean the collection, transport, recovery and disposal of waste, including the supervision of such operations and after-care of disposal sites;
(e) "disposal" shall mean any of the operations provided for in Annex II, A;
(f) "recovery" shall mean any of the operations provided for in Annex II, B;
(g) "collection" shall mean the gathering, sorting and/or mixing of waste for the purpose of transport.
Article 2
1. The following shall be excluded from the scope of this Directive:
(a) gaseous effluents emitted into the atmosphere;
(b) where they are already covered by other legislation:
(i) radioactive waste;
(ii) waste resulting from prospecting, extraction, treatment and storage of mineral resources and the working of quarries;
(iii) animal carcases and the following agricultural waste: faecal matter and other natural, non-dangerous substances used in farming;
(iv) waste waters, with the exception of waste in liquid form;
(v) decommissioned explosives.
2. Specific rules for particular instances or supplementing those of this Directive on the management of particular categories of waste may be laid down by means of individual Directives.
Article 3
1. Member States shall take appropriate measures to encourage:
(a) firstly, the prevention or reduction of waste production and its harmfulness, in particular by:
- the development of clean technologies more sparing in their use of natural resources,
- the technical development and marketing of products designed so as to make no contribution or to make the smallest possible contribution, by the nature of their manufacture, use or final disposal, to increasing the amount or harmfulness of waste and pollution hazards,
- the development of appropriate techniques for the final disposal of dangerous substances contained in waste destined for recovery;
(b) secondly:
(i) the recovery of waste by means of recycling, re-use or reclamation or any other process with a view to extracting secondary raw materials, or
(ii) the use of waste as a source of energy.
2. Except where Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (*) applies, Member States shall inform the Commission of any measures they intend to take to achieve the aims set out in paragraph 1. The Commission shall inform the other Member States and the committee referred to in Article 18 of such measures.
(*) OJ No L 109, 26. 4. 1983, p. 8.
Article 4
Member States shall take the necessary measures to ensure that waste is recovered or disposed of without endangering human health and without using processes or methods which could harm the environment, and in particular:
- without risk to water, air, soil and plants and animals,
- without causing a nuisance through noise or odours,
- without adversely affecting the countryside or places of special interest.
Member States shall also take the necessary measures to prohibit the abandonment, dumping or uncontrolled disposal of waste.
Article 5
1. Member States shall take appropriate measures, in cooperation with other Member States where this is necessary or advisable, to establish an integrated and adequate network of disposal installations, taking account of the best available technology not involving excessive costs. The network must enable the Community as a whole to become self-sufficient in waste disposal and the Member States to move towards that aim individually, taking into account geographical circumstances or the need for specialized installations for certain types of waste.
2. The network must also enable waste to be disposed of in one of the nearest appropriate installations, by means of the most appropriate methods and technologies in order to ensure a high level of protection for the environment and public health.
Article 6
Member States shall establish or designate the competent authority or authorities to be responsible for the implementation of this Directive.
Article 7
1. In order to attain the objectives referred to in Article 3, 4 and 5, the competent authority or authorities referred to in Article 6 shall be required to draw up as soon as possible one or more waste management plans. Such plans shall relate in particular to:
- the type, quantity and origin of waste to be recovered or disposed of,
- general technical requirements,
- any special arrangements for particular wastes,
- suitable disposal sites or installations.
Such plans may, for example, cover:
- the natural or legal persons empowered to carry out the managment of waste,
- the estimated costs of the recovery and disposal operations,
- appropriate measures to encourage rationalization of the collection, sorting and treatment of waste.
2. Member States shall collaborate as appropriate with the other Member States concerned and the Commission to draw up such plans. They shall notify the Commission thereof.
3. Member States may take the measures necessary to prevent movements of waste which are not in accordance ance with their waste management plans. They shall inform the Commission and the Member States of any such measures.
Article 8
Member States shall take the necessary measures to ensure that any holder of waste:
- has it handled by a private or public waste collector or by an undertaking which carries out the operations listed in Annex II A or B, or
- recovers or disposes of it himself in accordance with the provisions of this Directive.
Article 9
1. For the purposes of implementing Articles 4, 5 and 7, any establishment or undertaking which carries out the operations specified in Annex II A must obtain a permit from the competent authority referred to in Article 6.
Such permit shall cover:
- the types and quantities of waste,
- the technical requirements,
- the security precautions to be taken,
- the disposal site,
- the treatment method.
2. Permits may be granted for a specified period, they may be renewable, they may be subject to conditions and obligations, or, notably, if the intended method of disposal is unacceptable from the point of view of environmental protection, they may be refused.
Article 10
For the purposes of implementing Article 4, any establishment or undertaking which carries out the operations referred to in Annex II B must obtain a permit.
Article 11
1. Without prejudice to Council Directive 78/319/EEC of 20 March 1978 on toxic and dangerous waste (*), as last amended by the Act of Accession of Spain and Portugal, the following may be exempted from the permit requirement imposed in Article 9 or
Article 10:
(a) establishments or undertakings carrying out their own waste disposal at the place of production;
and
(b) establishments or undertakings that carry out waste recovery.
This exemption may apply only:
- if the competent authorities have adopted general rules for each type of activity laying down the types and quantities of waste and the conditions under which the activity in question may be exempted from the permit requirements,
and
- if the types or quantities of waste and methods of disposal or recovery are such that the conditions imposed in Article 4 are complied with.
2. The establishments or undertakings referred to in paragraph 1 shall be registered with the competent authorities.
3. Member States shall inform the Commission of the general rules adopted pursuant to paragraph 1.
(*) OJ No L 84, 31. 3. 1978, p. 43.
Article 12
Establishments or undertakings which collect or transport waste on a professional basis or which arrange for the disposal or recovery of waste on behalf of others (dealers or brokers), where not subject to authorization, shall be registered with the competent authorities.
Article 13
Establishments or undertakings which carry out the operations referred to in Articles 9 to 12 shall be subject to appropriate periodic inspections by the competent authorities.
Article 14
All establishments or undertakings referred to in Articles 9 and 10 shall:
- keep a record of the quantity, nature, origin, and, where relevant, the destination, frequency of collection, mode of transport and treatment method in respect of the waste referred to in Annex I and the operations referred to in Annex II A or B,
- make this information available, on request, to the competent authorities referred to in Article 6.
Member States may also require producers to comply with the provisions of this Article.
Article 15
In accordance with the "polluter pays" principle, the cost of disposing of waste must be borne by:
- the holder who has waste handled by a waste collector or by an undertaking as referred to in Article 9,
and/or
- the previous holders or the producer of the product from which the waste came.
Article 16
1. Every three years, and for the first time on 1 April 1995, Member States shall send the Commission a report on the measures taken to implement this Directive. This report shall be based on a questionnaire, drawn up in accordance with the procedure referred to in Article 18, which the Commission shall send to the Member States six months before the above date.
2. On the basis of the reports referred to in paragraph 1, the Commission shall publish a consolidated report every three years, and for the first time on 1 April 1996.
Article 17
The amendments necessary for adapting the Annexes to this Directive to scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 18.
Article 18
The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission.
The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the EEC Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.'
2. Articles 13, 14 and 15 become Articles 19, 20 and 21.
3. The following Annexes are added:
'ANNEX I
CATEGORIES OF WASTE
Q1 Production or consumption residues not otherwise specified below
Q2 Off-specification products
Q3 Products whose date for appropriate use has expired
Q4 Materials spilled, lost or having undergone other mishap, including any materials, equipment, etc., contaminated as a result of the mishap
Q5 Materials contaminated or soiled as a result of planned actions (e.g. residues from cleaning operations, packing materials, containers, etc.)
Q6 Unusable parts (e.g. reject batteries, exhausted catalysts, etc.)
Q7 Substances which no longer perform satisfactorily (e.g. contaminated acids, contaminated solvents, exhausted tempering salts, etc.)
Q8 Residues of industrial processes (e.g. slags, still bottoms, etc.)
Q9 Residues from pollution abatement processes (e.g. scrubber sludges, baghouse dusts, spent filters, etc.)
Q10 Machining/finishing residues (e.g. lathe turnings, mill scales, etc.)
Q11 Residues from raw materials extraction and processing (e.g. mining residues, oil field slops, etc.)
Q12 Adulterated materials (e.g. oils contaminated with PCBs, etc.)
Q13 Any materials, substances or products whose use has been banned by law
Q14 Products for which the holder has no further use (e.g. agricultural, household, office, commercial and shop discards, etc.)
Q15 Contaminated materials, substances or products resulting from remedial action with respect to land
Q16 Any materials, substances or products which are not contained in the above categories.
ANNEX IIA
DISPOSAL OPERATIONS
NB: This Annex is intended to list disposal operations such as they occur in practice. In accordance with Article 4, waste must be disposed of without endangering human health and without the use of processes or methods likely to harm the environment.
D1 Tipping above or underground (e.g. landfill, etc.)
D2 Land treatment (e.g. biodegradation of liquid or sludge discards in soils, etc.)
D3 Deep injection (e.g. injection of pumpable discards into wells, salt domes or naturally occuring repositories, etc.)
D4 Surface impoundment (e.g. placement of liquid or sludge discards into pits, ponds or lagoons, etc.)
D5 Specially engineered landfill (e.g. placement into lined discrete cells which are capped and isolated from one another and the environment, etc.)
D6 Release of solid waste into a water body except seas/oceans
D7 Release into seas/oceans including seabed insertion
D8 Biological treatment not specified elsewhere in this Annex which results in final compounds or mixtures which are disposed of by means of any of the operations in this Annex
D9 Physico-chemical treatment not specified elsewhere in this Annex which results in final compounds or mixtures which are disposed of by means of any of the operations in this Annex (e.g. evaporation, drying, calcination, etc.)
D10 Incineration on land
D11 Incineration at sea
D12 Permanent storage (e.g. emplacement of containers in a mine, etc.)
D13 Blending or mixture prior to submission to any of the operations in this Annex
D14 Repackaging prior to submission to any of the operations in this Annex
D15 Storage pending any of the operations in this Annex, excluding temporary storage, pending collection, on the site where it is produced.
ANNEX II B
OPERATIONS WHICH MAY LEAD TO RECOVERY
NB: This Annex is intended to list recovery operations as they are carried out in practice. In accordance with Article 4, waste must be recovered without endangering human health and without the use of processes or methods likely to harm the environment.
R1 Solvent reclamation/regeneration
R2 Recycling/reclamation of organic substances which are not used as solvents
R3 Recycling/reclamation of metals and metal compounds
R4 Recycling/reclamation of other inorganic materials
R5 Regeneration of acids or bases
R6 Recovery of components used for pollution abatement
R7 Recovery of components from catalysts
R8 Oil re-refining or other re-uses of oil
R9 Use principally as a fuel or other means to generate energy
R10 Spreading on land resulting in benefit to agriculture or ecological improvement, including composting and other biological transformation processes, except in the case of waste excluded under Article 2 (1) (b) (iii)
R11 Use of wastes obtained from any of the operations numbered R1 - R10
R12 Exchange of wastes for submission to any of the operations numbered R1 - R11
R13 Storage of materials intended for submission to any operation in this Annex, excluding temporary storage, pending collection, on the site where it is produced.'
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 April 1993. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, the measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
Article 3
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31991L0157 | 1991 | Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas any disparity between the laws or administrative measures adopted by the Member States on the disposal of batteries and accumulators could create barriers to trade and distort competition in the Community and may thereby have a direct impact on the establishment and functioning of the internal market; whereas it therefore appears necessary to approximate the laws in the field;
Whereas Article 2 (2) of Council Directive 75/442/EEC of 15 July 1975 on waste (4), as amended by Directive 91/156/EEC (5), provides that specific rules for particular instances or supplementing those of the said Directive in order to regulate the management of particular categories of waste shall be laid down by means of individual Directives;
Whereas the objectives and principles of the Community's environment policy, as set out in the European Community action programmes on the environment on the basis of the principles enshrined in Article 130r (1) and (2) of the EEC Treaty, aim in particular at preventing, reducing and as far as possible eliminating pollution and ensuring sound management of raw materials resources, on the basis also of the 'polluter pays' principle;
Whereas, in order to achieve these objectives, the marketing of certain batteries and accumulators should be prohibited, in view of the amount of dangerous substances they contain;
Whereas, to ensure that spent batteries and accumulators are recovered and disposed of in a controlled manner, Member States must take measures to ensure that they are marked and collected separately;
Whereas collection and recycling of spent batteries and accumulators can help avoid unnecessary use of raw materials;
Whereas appliances containing non-removable batteries or accumulators may represent an environmental hazard when they are disposed of; whereas Member States should therefore take appropriate measures;
Whereas programmes should be set up in the Member States to achieve the various objectives set out above; whereas the Commission should be informed of these programmes and of the specific measures taken;
Whereas recourse to economic instruments such as the setting up of a deposit system may encourage the separate collection and recycling of spent batteries and accumulators;
Whereas provision should be made for consumer information in this field;
Whereas provision should be made for appropriate procedures to implement the provisions of this Directive, particularly the making system, and to ensure that the Directive can be easily adapted to scientific and technical progress; whereas the committee referred to in Article 18 of Directive 75/442/EEC should be instructed to assist the Commission in these tasks,
Article 1
The aim of this Directive is to approximate the laws of the Member States on the recovery and controlled disposal of those spent batteries and accumulators containing dangerous substances in accordance with Annex I.
Article 2
For the purposes of this Directive:
(a) 'battery or accumulator' means a source of electrical energy generated by direct conversion of chemical energy and consisting of one or more primary (non-rechargeable) batteries or secondary (rechargeable) cells, as listed in Annex I;
(b) 'spent battery or accumulator' means a battery or accumulator which is not re-usable and is intended for recovery or disposal;
(c) 'disposal' means any operation, provided that it is applicable to batteries and accumulators, included in Annex II A to Directive 75/442/EEC;
(d) 'recovery' means any operation, provided that it is applicable to batteries and accumulators, included in Annex II B to Directive 75/442/EEC;
(e) 'collection' means the gathering, sorting and/or grouping together of spent batteries and accumulators;
(f) 'deposit system' means a system under which the buyer, upon purchase of batteries or accumulators, pays the seller a sum of money which is refunded when the spent batteries or accumulators are returned.
Article 3
1. Member States shall prohibit, as from 1 January 1993, the marketing of:
- alkaline manganese batteries for prolonged use in extreme conditions (e.g. temperatures below 0° C or above 50° C, exposed to shocks) containing more than 0,05 % of mercury by weight,
- all other alkaline manganese batteries containing more than 0,025 % of mercury by weight.
Alkaline manganese button cells and batteries composed of button cells shall be exempted from this prohibition.
2. Paragraph 1 shall be inserted in Annex I to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (6), as last amended by Directive 85/610/EEC (7).
Article 4
1. In the context of the programmes referred to in Article 6, Member States shall take appropriate steps to ensure that spent batteries and accumulators are collected separately with a view to their recovery or disposal.
2. To this end, Member States shall ensure that batteries and accumulators and, where appropriate, appliances into which they are incorporated are marked in the appropriate manner.
The marking must include indications as to the following points:
- separate collection,
- where appropriate, recycling,
- the heavy-metal content.
3. The Commission shall draw up, in accordance with the procedure referred to in Article 10, the detailed arrangements for the marking system. These arrangements shall be published in the Official Journal of the European Communities.
Article 5
Member States shall take measures to ensure that batteries and accumulators cannot be incorporated into appliances unless they can be readily removed, when spent, by the consumer.
These measures shall enter into force on 1 January 1994.
This Article shall not apply to the categories of appliance included in Annex II.
Article 6
Member States shall draw up programmes in order to achieve the following objectives:
- reduction of the heavy-metal content of batteries and accumulators,
- promotion of marketing of batteries and accumulators containing smaller quantities of dangerous substances and/or less polluting substances,
- gradual reduction, in household waste, of spent batteries and accumulators covered by Annex I,
- promotion of research aimed at reducing the dangerous-substance content and favouring the use of less polluting substitute substances in batteries and accumulators, and research into methods of recycling,
- separate disposal of spent batteries and accumulators covered by Annex I.
The first programmes shall cover a four-year period starting on 18 March 1993. They shall be communicated to the Commission by 17 September 1992 at the latest.
The programmes shall be reviewed and updated regularly, at least every four years, in the light in particular of technical progress and of the economic and environmental situation. Amended programmes shall be communicated to the Commission in good time.
Article 7
1. Member States shall ensure the efficient organization of separate collection and, where appropriate, the setting up of a deposit system. Furthermore, Member States may introduce measures such as economic instruments in order to encourage recycling. These measures must be introduced after consultation with the parties concerned, be based on valid ecological and economic criteria and avoid distortions of competition.
2. When notifying the programmes to which Article 6 refers, Member States shall inform the Commission of the measures they have taken pursuant to paragraph 1.
Article 8
In the context of the programmes referred to in Article 6, Member States shall take the necessary steps to ensure that consumers are fully informed of:
(a) the dangers of uncontrolled disposal of spent batteries and accumulators;
(b) the marking of batteries, accumulators and appliances with permanently incorporated batteries and accumulators;
(c) the method of removing batteries and accumulators which are permanently incorporated into appliances.
Article 9
Member States may not impede, prohibit or restrict the marketing of batteries and accumulators covered by this Directive and conforming to the provisions laid down herein.
Article 10
The Commission shall adapt Articles 3, 4 and 5 and Annexes I and II to technical progress in accordance with the procedure laid down in Article 18 of Directive 75/442/EEC.
Article 11
1. Member States shall take the measures necessary to comply with this Directive before 18 September 1992. They shall forthwith inform the Commission thereof.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 12
This Directive is addressed to the Member States. | [
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31991L0188 | 1991 | Commission Directive 91/188/EEC of 19 March 1991 amending for the fifth time the Annex to Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (1), as last amended by Directive 90/533/EEC (2), and in particular Article 6 thereof,
Whereas the development of scientific and technical knowledge makes necessary certain amendments to the Annex to Directive 79/117/EEC;
Whereas it seems desirable to delete the remaining temporary derogations from the prohibitions laid down in the Directive since less hazardous treatments are now available;
Whereas all Member States have informed the Commission that they do not intend or no longer intend to avail themselves of these derogations;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
In Part A of the Annex to Directive 79/117/EEC, 'Mercury compounds', the text in column 2 is hereby deleted. Article 2
Member States shall, not later than 31 March 1992, bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof.
When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be laid down by Member States. Article 3
This Directive is addressed to the Member States. | [
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31991L0173 | 1991 | Council Directive 91/173/EEC of 21 March 1991 amending for the ninth time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas measures should be adopted with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers on which the free movement of goods, persons, services and capital is ensured;
Whereas both pentachlorophenol (CAS No 87-86-5) and its compounds are substances that are dangerous to man and the environment, and in particular the aquatic environment; whereas the use of those substances should be regulated;
Whereas restrictions which have already been imposed by certain Member States on the use of marketing of the abovementioned substances or of preparations containing those substances directly affect the establishment and operation of the internal market; whereas it is therefore necessary to approximate the laws of the Member States in this field and, consequently, to amend Annex I to Directive 76/769/EEC (4), as last amended by Directive 89/678/EEC (5);
Whereas the Commission will be developing a coordinated Community strategy regarding the placing on the market and use of chemical products used for the preservation of wood; whereas this strategy will be based on information supplied to it by the Member States and in particular on the assessment of the risks for man and the environment while taking into account the various problems posed by wood preservation in the Member States;
Whereas currently Community legislation concerning the possible adoption by Member States of more stringent restrictions on the use of the substances and preparations in question at the workplace remains unaffected by this Directive,
Article 1
The following point is hereby added to Annex I to Directive 76/769/EEC:
'23. Pentachlorophenol
(CAS No 87-86-5)
and its salts and esters shall not be used in a concentration equal to or greater than 0,1 % by mass in substances or preparations placed on the market. By way of exception, this provision shall not apply to substances and preparations intended for use in industrial installations not permitting the emission and/or discharge of pentachlorophenol (PCP) in quantities greater than those prescribed by existing legislation: (a) in the treatment of wood. However, treated wood may not be used: - inside buildings whether for decorative purposes or not whatever their purpose (residence, employment, leisure); - for the manufacture of containers intended for growing purposes and any re-treatment and the manufacture of packaging which may come into contact with or other materials which may contaminate raw, intermediate and/or finished products intended for human and/or animal consumption and any re-treatment; (b) in the impregnation of fibres and heavy-duty textiles not intended in any case for clothing or for decorative furnishings; (c) as a synthesizing and/or processing agent in industrial processes; (d) by way of special exception, Member States may on a case-by-case basis, authorize on their territory specialized professionals to carry out in situ and for buildings of cultural, artistic and historical interest, or in emergencies, a remedial treatment of timber and masonry infected by dry rot fungus (Serpula lacrymans) and cubic rot fungi. These exceptions shall be re-examined in the light of developments in knowledge and techniques not more than three years after the implementation of the Directive. In any case: (a) Pentachlorophenol used alone or as a component of preparations employed within the framework of the above exceptions must have a total hexachlorodibenzoparadioxin (H6CDD) content below four parts per million (ppm); (b) these substances and preparations may not: - be placed on the market except in packages of 20 litres or more; - be sold to the general public. Without prejudice to the implementation of other Community provisions concerning the classification, packaging and labelling of dangerous substances and preparations, the packaging of such preparations should be marked clearly and indelibly: "Reserved for industrial and professional use". In addition, this provision shall not apply to waste covered by Directives 75/442/EEC and 78/319/EEC.'
Article 2
1. Member States shall communicate to the Commission before 31 December 1991 the text of the main provisions of national law which they adopt in the field covered by this Directive.
2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1992. They shall inform the Commission thereof. Article 3
This Directive is addressed to the Member States. | [
"UKSI19930001"
] |
31991L0174 | 1991 | Council Directive 91/174/EEC of 25 March 1991 laying down zootechnical and pedigree requirements for the marketing of pure-bred animals and amending Directives 77/504/EEC and 90/425/EEC
Having regard to the Treaty establishing the European Economic Community, in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas pure-bred animals, being 'live animals', are included in the list in Annex II to the Treaty;
Whereas pure-bred animals are generally reared in the context of farming activities; whereas the rearing of such animals constitutes a source of income for part of the farming population and should therefore be encouraged;
Whereas specific rules for the harmonization of zootechnical legislation have been laid down at Community level for cattle, swine, sheep, goats and equidae;
Whereas, to ensure the rational development of the rearing of pure-bred animals and thus increase productivity in that sector, rules for the marketing of such animals should be laid down at Community level;
Whereas, in principle, intra-Community trade must not be prohibited, restricted or impeded;
Whereas it is appropriate that the provisions applicable to pure-bred breeding cattle should be extended to pure-bred breeding buffalo and that Directive 77/504/EEC (4) should be amended as a result;
Whereas it should be stipulated that the provisions of Directive 90/425/EEC (5) apply to this sector;
Whereas provisions should be introduced preventing pure-bred animals from being imported from third countries on terms which are more favourable than those applied within the Community,
Article 1
For the purposes of this Directive 'pure-bred animal' shall mean any animal for breeding covered by Annex II to the Treaty the trade in which has not yet been the subject of more specific Community zootechnical legislation and which is entered or registered in a register or pedigree record kept by a recognized breeders' organization or association. Article 2
Member States shall ensure that:
- the marketing of pure-bred animals and of the semen, ova and embryos thereof is not prohibited, restricted or impeded on zootechnical or pedigree grounds,
- in order to ensure that the requirement provided for in the first indent is satisfied, the criteria for approval and recognition of breeders' organizations or associations, the criteria for entry or registration in pedigree records or registers, the criteria for approval for reproduction of pure-bred animals and for the use of their semen, ova and embryos, and the certificate to be required for their marketing should be established in a non-discriminatory manner, with due regard for the principles laid down by the organization or association which maintains the register or pedigree record of the breed in question.
Pending the implementation of detailed rules for application as provided for in Article 6, national laws shall remain applicable with due regard for the general provisions of the Treaty. Article 3
In Article 1 (a) of Directive 77/504/EEC the words, 'including buffalo' shall be inserted after the term 'bovine species'. Article 4
The following text shall be added in Section II of Annex A to Directive 90/425/EEC:
'Council Directive 91/174/EEC of 25 March 1991 laying down zootechnical and pedigree requirements for the marketing of pure-bred animals
OJ No L 85, 9. 4. 1991, p. 37.' Article 5 Until Community rules on the subject are implemented, the conditions applicable to imports of pure-bred animals and to the semen, ova and embryos thereof from third countries shall not be more favourable than those governing intra-Community trade. Article 6
The detailed rules for the application of this Directive shall be adopted in accordance with the procedure laid down in Article 11 of Directive 88/661/EEC (6). Article 7
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1992. They shall forthwith inform the Commission thereof.
When the said measures are adopted by the Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 8
This Directive is addressed to the Member States. | [
"UKSI19922370"
] |
31991L0226 | 1991 | Council Directive 91/226/EEC of 27 March 1991 on the approximation of the laws of the Member States relating to the spray-suppression systems of certain categories of motor vehicles and their trailers
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
Whereas the technical requirements which certain categories of motor vehicles and their trailers must satisfy pursuant to national laws relate, inter alia, to the spray-suppression systems of such motor vehicles;
Whereas these requirements differ from one Member State to another; whereas it is therefore necessary that all Member States adopt the same requirements in order, in particular, to allow the implementation for each type of vehicle of the EEC type-approval procedure which was the subject of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4), as last amended by Directive 87/403/EEC (5);
Whereas, with a view to improving road safety, it is important that all commercial vehicles in higher weight categories and with a certain minimum design speed should be equipped with efficient spray-suppression systems in order to retain water;
Whereas it is desirable to establish a single performance test for systems of this type on fitting to the various types of vehicles as a means of markedly improving the situation;
whereas for the EEC component type-approval of devices of this type account has been taken of the two types of devices currently on the marked, i.e. the energy-absorption type and the air/water separator type; whereas it has been necessary to provide for two different tests depending on the type of device to be approved;
Whereas, in the light of the studies, research and tests currently in progress, a performance test on the types of vehicles fitted with these devices will be established as soon as possible;
Whereas Member States should pay attention to the fact that the formation of spray depends also on the characteristics of the road surface, the tyre-tread configuration and the speed and aerodynamic characteristics of the vehicle;
Whereas the approximation of national laws relating to motor vehicles entails the mutual recognition by Member States of the inspections carried out by each of them on the basis of common requirements,
Article 1 1. Member States shall grant EEC component type-approval for any type of device, hereinafter referred
to as 'spray-suppression device', intended to reduce the projection of spray from tyres of moving vehicles, if it satisfies the requirements regarding design and testing set out in Annex II and taking into account the definitions given in Annex I.
2. A Member State which has granted EEC component type-approval shall take the measures required to verify, in so far as is necessary and, if need be, in cooperation with the competent authorities of the other Member States, that production models conform to the approved type. For this purpose the Member State shall apply the requirements of Annex IV. Article 2 Member States shall, for each spray-suppression device which they approve pursuant to Article 1, issue to the
manufacturer or to his authorized representative an EEC component type-approval mark conforming to the model in Annex II, Appendix 3.
Member States shall take all appropriate measures to prevent the use of marks liable to create confusion between spray-suppression devices which have been approved pursuant to Article 1 and other devices. Article 3 No Member State may prohibit the placing on the market
of spray-suppression devices on grounds relating to their construction and performance if they bear the EEC component type-approval mark.
Nevertheless, this provision shall not prevent a Member State from taking such measures with regard to spray-suppression devices bearing the EEC component type-approval mark which consistently fail to conform to the approved type.
The Member State concerned shall forthwith inform the other Member States and the Commission of the measures taken, specifying the reason for its decision. The provisions of Article 5 shall also apply.
Devices shall be deemed not to conform to the approved
type, within the meaning of the second paragraph, if the requirements of Annex II have not been respected. Article 4 The competent authorities of each Member State shall, within one month, send the competent authorities of the other Member States copies of the EEC component type-approval certificates issued for each type of spray-suppression device which they approve or refuse to approve. Article 5 1. If the competent authorities of a Member State which has granted EEC component type-approval find that spray-suppression devices accompanied by certificates of conformity to a single type do not conform to the type approved by that Member State, they shall take the necessary measures to ensure that the conformity of production models to the approved type is restored. They shall advise the competent authorities of the other Member States of the measures taken, which may extend to withdrawal of EEC component type-approval.
The said authorities shall take the same measures if they are informed by the competent authorities of another Member State of such failure to conform.
2. The competent authorities of the Member State shall, within one month, inform each other of a withdrawal of EEC component type-approval, by forwarding a copy of the component type-approval certificate, signed and dated and bearing in large letters the words 'EEC TYPE-APPROVAL WITHDRAWN', and adducing reasons for any such measure.
3. If the Member State which has granted the EEC component type-approval challenges the alleged lack of conformity, the Member States concerned shall endeavour to settle the disagreement. The Commission shall be kept informed. Where necessary, it shall arrange for appropriate discussions with a view of arriving at a solution. Article 6 Any decision taken pursuant to the provisions adopted in implementation of this Directive to refuse or withdraw EEC component type-approval for spray-suppression devices or prohibit their placing on the market or use shall set out in detail the reason on which it is based. Such decision shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member States and of the time limits laid down for availing himself of such remedies. Article 7 For the purposes of this Directive, 'vehicle' means any motor vehicle in category N and any trailer in category O as defined in Annex I to Directive 70/156/EEC. Article 8 No Member State may refuse to grant EEC type-approval or national type-approval for vehicles, or refuse or prohibit their sale, registration, placing in service or use on grounds relating to their spray-suppression system if these are fitted
in accordance with the requirements of Annex III and if
the spray-suppression devices with which the vehicles are equipped bear the EEC component type-approval mark. Article 9 Any amendments necessary in order to adapt the requirements of the Annexes to this Directive to take account of technical progress shall be adopted in accordance with
the procedure laid down in Article 13 of Directive 70/156/EEC. Article 10 1. Member States shall bring into force the provisions necessary in order to comply with this Directive by 10 April 1992. They shall forthwith inform the Commission thereof.
2. Member States shall communicate the main provisions of national law which they adopt in the field covered by this Directive to the Commission.
3. When Member States adopt the provisions referred
to in paragraph 1, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 11
This Directive is addressed to the Member States. | [
"UKSI19912830",
"UKSI19912681",
"UKSI19920646"
] |
31991L0191 | 1991 | Council Directive 91/191/EEC of 27 March 1991 amending Directive 69/169/EEC on tax-paid allowances in intra- Community travel and as regards a derogation granted to the Kingdom of Denmark and to Ireland relating to the rules governing travellers' allowances on imports
Having regard to the Treaty establishing the European Economic Community, and in particular Article 99 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Article 8a of the Treaty defines the internal market as an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured and states that this market should be progressively established over a period expiring on 31 December 1992;
Whereas the system of travellers' allowances applies to goods which move about tax paid and in this respect anticipates the mode of movement of goods which will apply in the internal market;
Whereas, taking into account the progressive nature of the creation of the internal market as stated in Article 8a of the Treaty, an increase is necessary, as a first step, for the value allowance both for this market and for achieving the aim of Council Directive 69/169/EEC of 28 May 1969 on the harmonization of provisions laid down by law, regulation or administrative action relating to exemption from turnover tax and excise duty on imports in international travel (4), as last amended by Directive 89/194/EEC (5), as set out in the second recital thereto; whereas establishing the market means that goods bought tax paid will be able to be taken across internal frontiers without any liability to pay further tax and that the existing allowances for travellers will cease to exist because they will have no meaning;
Whereas it is necessary in the same way to phase out all differences in the treatment of travellers entering various Member States;
Whereas it is necessary, for a limited period, to provide derogations for Ireland and the Kingdom of Denmark in view of the economic difficulties caused by the application of the general levels of allowances,
Article 1
Directive 69/169/EEC is hereby amended as follows:
1. In Article 2, as from 1 July 1991:
- in paragraph 1, 'ECU 390' is replaced by 'ECU 600',
- in paragraph 2, 'ECU 100' is replaced by 'ECU 150'.
2. In Article 5, the following paragraph is inserted and paragraphs 5, 6 and 7 are renumbered 6, 7 and 8:
'5. In the case of Ireland and the Kingdom of Denmark, in no case shall the restrictions in paragraph 1 be such that those to whom the restrictions apply are able to enjoy a more favourable treatment than that accorded by the limits set out in Articles 7c and 7d. The restrictions set out in paragraph 1 shall be calculated by reference to Articles 2 and 4 (1) column II of the table.'
3. In Article 7b, as from 1 July 1991:
(a) In paragraph 1:
- subparagraph (a) is replaced by the following:
'(a) the Kingdom of Denmark and the Hellenic Republic shall be authorized to exclude, from the exemption, goods the unit value of which exceeds ECU 340.'
- in subparagraph (b), 'ECU 85' is replaced by 'ECU 95'.
(b) In paragraph 2, 'ECU 85' is replaced by 'ECU 95'.
4. Article 7c shall be replaced by the following:
'Article 7c
Notwithstanding Articles 2 (1) and 4 (1), the Kingdom of Denmark shall be authorized to apply the following quantitative limits until 31 December 1991 for the importation of the goods in question by travellers resident in Denmark after a stay of less than 36 hours outside Denmark:
Products - Cigarettes 100 - Distilled beverages and spirits of an alcoholic strength by volume more than 22 % vol. nil - Beer 12 litres'
5. The following Article 7d is added:
'Article 7d
Notwithstanding Article 2 (1) and within the limit set out therein, Ireland shall be authorized to apply a quantitative limit of 25 litres of beer for all travellers to Ireland until 31 December 1991.
Notwithstanding Articles 2 (1) and 4 (1), Ireland shall be authorized to apply the following limits until 31 December 1991 for the importation of the goods in question by travellers from Ireland after a stay of less than 24 hours outside Ireland:
(a) for travellers from the Community, ECU 110,
(b)
Products - Cigarettes or 150 - Smoking tobacco 200 g - Distilled beverages and spirits of an alcoholic strength by volume of more than 22 %; or 3/4 litre or - Distilled beverages and spirits, and aperitifs with a wine or alcohol base, sake or similar beverages of an alcoholic strength by volume of 22 % or less; sparking wines, fortified wines and 1,5 litres - Still wines (*), 2,5 litres - Beer 12 litres
(*) For travellers from third countries, the limit for still wines provided for in Article 4(1) shall apply.' Article 2
1. Member States shall bring into force the measures necessary to comply with this Directive:
- as regards Article 1, points 1, 2 and 3, with effect from 1 July 1991,
- as regards Article 1, points 4 and 5, on the day of notification (6) of this Directive to the Member States.
2. When the Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Member States shall inform the Commission of the main provisions of domestic law which they adopt in order to comply with this Directive. Article 3
This Directive is addressed to the Member States. | [
"UKSI19911286"
] |
31991L0184 | 1991 | Thirteenth Commission Directive 91/184/EEC of 12 March 1991 adapting to technical progress Annexes II, III, IV, V, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 90/121/EEC (2), and in particular Article 8 (2) thereof,
Whereas, on the basis of the available information, certain provisionally permitted colouring agents, substances and preservatives may be definitively permitted, while others must be definitively prohibited or be permitted for a further specified period;
Whereas, in order to protect public health, it is necessary to prohibit the use of lidocaine and thiomersal;
Whereas, on the basis of the latest scientific and technical research, the use of magnesium fluoride may be permitted subject to certain restrictions and obligatory inclusion on the label of health warnings;
Whereas, on the basis of the latest scientific and technical research, 7-ethyl bicyclo-oxazolidine may be used as a preservative up to 31 December 1992 and 3,3-(1.4-phenylene dimethylidyne) bis (7,7-dimethyl-2-oxo-bicyclo-(2,2,1) heptane-1-methane sulphonic acid) and its salts may be used as an ultraviolet filter in cosmetic products subject to certain restrictions and conditions;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the removal of technical barriers to trade in the cosmetic products sector,
Article 1
Directive 76/768/EEC is hereby amended as follows:
1. Annex II
(a) No 221, 'in Annexes V and VI, Part 1' is replaced by 'in Annex VI, Part 1';
(b) the following numbers are added:
'395. hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III, Part 1 396. dithio-2,2-bispyridine-dioxide 1,1 (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate) 397. Colouring agent CI 12075 and its lakes, pigments and salts 398. Colouring agent CI 45170 and CI 45170:1 399. Lidocaine'
2. In Annex III, Part 1, reference No 56 is added:
a b c d e f '56 Magnesium fluoride Dental hygiene
products 0,15 % calculated as F when mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % Contains magnesium
fluoride'
3. Annex III, Part 2
(a) reference Nos 1 and 4 are deleted;
(b) '31 December 1990' in the column 'Allowed until' is replaced by '31 December 1991' for the following number: 2. 1,1,1-Trichloroethane (methyl chloroform);
4. In Annex IV, Part 1, Nos 12075, 15585, 45170 and 45170:1 are deleted;
5. In Annex IV, Part 2:
(a) '31 December 1990' in the column 'Allowed until' is replaced by '31 December 1991' for Nos 26 100 and 73 900;
(b) the following colouring agent is added:
'Colour index No or denomination Colour Field of application Other limitations and requirements Allowed until 1 2 3 4 15 585 (3) Red × Maximum 3 % in the products intended to come into contact with mucous membranes 31. 12. 1991 (3) Lakes, pigments or salts of barium, strontium and zirconium insoluble in these colouring agents are also allowed. They must satisfy the insolubility test, which will be determined in accordance with the procedure provided for in Article 8';
6. In Annex V, reference Nos 7 and 8 are deleted;
7. In Annex VI, Part 1, the following reference numbers are added:
a b c d e '44 Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*) 0,1 % 45 4,4-dimethyl-1,3-oxazolidine 0,1 % The pH of the finished product must not be lower than 6.' 46 N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-
imidazolidinyl-4)-N-(hydroxymethyl) urea 0,5 %
8. Annex VI, Part 2:
(a) '31. 12. 1990' in column (f) is replaced by '31. 12. 1991' for the following substances:
2. Ether p-chlorophenyl glycerol (Chlorphenesin)
15. Diisobutyl-phenoxy-ethoxy-ethyl dimethyl benzyl ammonium, chloride (+) (benzethonium chloride)
16. Alkyl (C8-C18) dimethylbenzyl ammonium chloride, bromide and saccharinate (+) (benzalkonium chloride, bromide and saccharinate)
20. 1,6-di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethioniate and p-hydroxybenzoate (+))
21. Benzylmiformal
27. Decyloxy-3-hydroxy-2amino-1 propane hydrochlorate (Decominol (DCI));
(b) reference Nos 4, 6 and 17 are deleted;
(c) the following reference number is added:
a b c d e f '28 7-Ethylbicyclooxa-
zolidine 0,3 % Prohibited in dental hygiene products and in products intended to come into contact with mucous membranes 31 12. 1992'
9. In Annex VII, Part 1, the following reference number is added:
a b c d e '7 3,3-(1,4-Phenylenedimethylidyne) bis
(7,7-dimethyl-2-oxo-bicyclo-(2,2,1) heptane-1-methane-sulphonic acid) and its salts 10 %
(expressed
in acid) Prohibited in aerosols (sprays)'
Article 2 1. Regardless of the dates of admission mentioned in Article 1 (3) (b), (5) and (8) (a) and (c), Member States shall take all the necessary measures to ensure that as from 1 January 1992, for the substances mentioned in Article 1 (1), and as from 1 January 1993, for the substances mentioned in Article 1 (2) to (9), neither manufacturers nor importers established in the Community shall place on the market products which do not comply with the requirements of this Directive.
2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances mentioned in Article 1 (1) shall no longer be sold or otherwise surrendered to the final consumer after 31 December 1992 and that the products containing the substances mentioned in Article 1 (2) to (9) shall no longer be sold or surrendered to the final consumer after 31 December 1994, if they do not comply with the requirements of this Directive. Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive no later than 31 December 1991. They shall forthwith inform the Commission thereof.
2. When the Member States adopt these provisions these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
3. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. Article 4
This Directive is addressed to the Member States. | [
"UKSI19921525"
] |
31991L0249 | 1991 | Commission Directive 91/249/EEC of 19 April 1991 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 91/248/EEC (2), and in particular Article 7 thereof,
Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge;
Whereas a new use of the trace element 'ferrous sulphate, monohydrate' has been successfully tested in certain Member States; whereas, on the basis of experience gained it appears that this new use can be authorized throughout the Community;
Whereas too high an addition of vitamin A in feedingstuffs can have undesirable effects on quality of production animals; whereas, given this fact, it appears necessary, while waiting for the results of certain studies, to introduce maximum levels to ensure upkeep and productivity of animals during the finishing period;
Whereas the use of various additives belonging to the groups of antibiotics and binders has been successfully tested in certain Member States; whereas it is appropriate to allow provisionally these new uses at national level until their authorization on a Community level;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs,
Article 1
The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex hereto.
Article 2
Member States shall, by 30 November 1991 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19912840"
] |
31991L0238 | 1991 | Council Directive 91/238/EEC of 22 April 1991 amending Directive 89/396/EEC on indications or marks identifying the lot to which a foodstuff belongs
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas it is necessary to take account of the fact that the immediate consumption on purchase of certain foodstuffs such as ice cream in individual portions means that indicating the lot directly on the individual packaging would serve no useful purpose; whereas Directive 89/396/EEC (4) should therefore be amended;
Whereas, however, it must be compulsory in the case of these products to indicate the lot on the combined package,
Article 1
The following is hereby added to Article 2 (2) of Directive 89/396/EEC:
'(d) to individual portions of ice cream. The indication enabling the lot to be identified must appear on the combined package.' Article 2 This Directive is addressed to the Member States. | [
"UKSI19921357",
"UKSI19961502"
] |
31991L0263 | 1991 | Council Directive 91/263/EEC of 29 April 1991 on the approximation of the laws of the Member States concerning telecommunications terminal equipment, including the mutual recognition of their conformity
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission(1),
In cooperation with the European Parliament(2),
Having regard to the opinion of the Economic and Social Comittee(3),
Whereas Directive 86/361/EEC(4) introduced the initial stage of the mutual recognition of type approval for telecommunications terminal equipment and in particular in its Article 9 envisaged a further stage for full mutual recognition of type approval for terminal equipment;
Whereas Decision 87/95/EEC(5) sets out the measures to be implemented for the promotion of standardization in
Europe and the preparation and implementation of standards in the field of information technology and telecommunications;
Whereas the Commission has issued a Green Paper on the development of the common market for telecommunications services and equipment proposing to acclerate the introduction of the full mutual recognition of type approval as the measure vital for the development of a competitive Community-wide terminal market;
Whereas the Council, in its resolution of 30 June 1988 on the development of the common market for telecommunications services and equipment up to 1992(6), considers as a major goal in the telecommunications policy the full mutual recognition of type approval for terminal equipment on the basis of the rapid development of common European conformity specifications;
Whereas the terminal equipment sector is a vital part of the telecommunications industry, which is one of the industrial mainstays of the economy in the Community;
Whereas harmonizing conditions for the placing on the market of telecommunications terminal equipment will create the conditions for an open and unified market;
Whereas real, comparable access to third country markets for European manufacturers should preferably the achieved through multilateral negotiations within GATT, although bilateral talks between the Community and third countries may also contribute to this process;
Whereas the Council resulution of 7 May 1985 provides for a new approach to technical harmonization and standards(7);
Whereas the scope of the Directive must be based on a general definition of the term 'terminal equipment' so as to allow the technical development of products;
Whereas Community law in its present form provides - notwithstanding one of the fundamental rules of the Community, namely the free movement of goods - that obstacles to movement within the Community, resulting from disparities in national legislation relating to the marketing of products, must be accepted in so far as such requirements can be recognized as being necessary to satisfy imperative requirements; whereas, therefore, the harmonization of laws in this case must be limited only to those requirements necessary to satisfy the essential requirements relating to terminal equipment; whereas these requirements must replace the relevant national requirements because they are essential;
Whereas the essential requirements must be satisfied in order to safeguard the general interest; whereas these requirements must be applied with discernment to take account of the state of the art at the time of manufacture and economic requirements;
Whereas Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits(8) and Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations(9), as amended by Directive 88/182/EEC(10), are applicable, inter alia, to the fields of telecommunications and information technology;
Whereas Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of Member States
relating to electromagnetic compatibility(11) is applicable, inter alia, to the fields of telecommunications and information technology; whereas it is, however, appropriate to delete the provisions of Directive 89/336/EEC in so far as they refer to the definition of telecommunications terminal equipment and to the conformity assessment procedures to be applied for such equipment;
Whereas in respect of the essential requirements and in order to help manufacturers to prove conformity to those requirements, it is desirable to have standards harmonized at European level to safeguard the general interest in the design and manufacture of terminal equipment and in order to allow checks of conformity to those requirements; whereas these standards harmonized at European level are
drawn up by private-law bodies and must retain their nonbinding status; whereas for this purpose the Europen Committee for Standardization (CEN), the European Commttee for Electrotechnical Standardization (Cenelec) and the European Telecommunications Standards Institute (ETSI), are the bodies recognized as competent to adopt harmonized standards; whereas, within the meaning of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by one of these bodies, on the basis of a remit from the Commission in accordance with the provision of Directive 83/189/EEC, and in accordance with the general guidelines referred to above;
Whereas in respect of the essential requirements related to interworking with public telecommunications networks, and in cases where it is justified, through such networks, it is in general not possible to comply with such requirements other than by the application of unique technical solutions; whereas such solutions shall therefore be mandatory;
Whereas the proposals for common technical regulations are, as a general rule, drawn up on the basis of harmonized standards, and, in order to ensure an appropriate technical coordination on a broad European basis, of additional consultations, in particular with the Telecommunications Regulations Application Committee (TRAC) set up by members of the European Conference of Postal and Telecommunications Administrations (CEPT) in a memorandum of understanding signed in 1991;
Whereas it is essential to ensure that notified bodies are of a high standard throughout the Community and meet minimum criteria of competence, impartiality and financial and other independence from clients;
Whereas it is appropriate to set up a committee bringing together parties directly concerned with the implementation
of this Directive, in particular the national bodies designated for certifying conformity, to assist the Commission in executing the tasks entrusted to it by this Directive; whereas representatives from the telecommunication organizations, users, consumers, manufacturers, service providers and the trade unions should have the right to be consulted;
Whereas the Member States' responsibility for safety, health and the other aspects covered by the essential requirements on their territory must be recognized in a safeguard clause providing for adequate Community protection procedures;
Whereas the addressees of any decision taken under this Directive must be informed of the reasons for such a decision and the means of appeal open to them;
Whereas measures must be adopted with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured,
CHAPTER 1 Scope, placing on the market and free circulation Article 1
1. This Directive shall apply to terminal equipment.
2. For the purpose of this Directive:
-'public telecommunications network' means the public telecommunications infrastructure which permits the conveyance of signals between defined network termination points by wire, by microwave, by optical means or by other electromagnetic means,
-'terminal equipment' means equipment intended to be connected to the public telecommunications network, i.e.:
(a)to be connected directly to the termination of a public telecommunications network;
or
(b)to interwork with a public telecommunications network being connected directly or indirectly to the termination of a public telecommunications network
in order to send, process or receive information.
The system of connection may be wire, radio, optical or other electromagnetic system,
-'technical specification' means a specification contained in a document which lays down the characteristics required of a product such as levels of quality, performance, safety or dimensions, including the requirements applicable to the product as regards terminology, symbols, testing and test methods, packaging, marking and labelling,
-'standard' means a technical specification adopted by a recognized standards body for repeated or continuous application, compliance with which is not compulsory.
3. The intended purpose of the equipment, shall be declared by the manufacturer or supplier of the equipment. However, terminal equipment within the meaning of paragraph 2 which makes use of a system of communication employing the radio frequency spectrum is presumed to be intended for connection to the public telecommunications network.
Article 2 1. Notwithstanding Article 1, equipment which is capable of being connected to the public telecommunications network, but is not intended for such a purpose, shall be accompanied by a manufacturer's or supplier's declaration, the model of which is to be found in Annex VIII and by the operating manual. At the time of placing the equipment on the market for the first time, a copy of such documentation shall be transmitted to the notified body referred to in Article 10 (1) in the Member State where this first placing on the market takes place. In addition, such equipment shall be subject to the provisions of Article 11 (4).
2. The manufacturer or supplier shall be prepared to justify once, at the request of any notified body referred to in Article 10 (1), the intended purpose of such equipment on the basis of its relevant technical characteristics, its functions and indications of the market segment it is intended for.
Article 3 1. Member States shall take all appropriate measures to ensure that terminal equipment may be placed on the market and put into service only if it complies with the requirements laid down in this Directive when it is properly installed and maintained and used for its intended purpose.
2. Member States shall also take all appropriate measures to ensure that equipment referred to in Article 2 may be placed and allowed to remain on the market only if it complies with the requirements laid down by this Directive for this equipment and may not be connected to the public telecommunications network within the meaning of
Article 1
(2).
3. Member States shall also take all appropriate measures to ensure that terminal equipment or equipment referred to in Article 2 is disconnected from the public telecommunications network if it is not used for its intended purpose. Member States may moreover take all appropriate measures, according to their national laws, to prevent connection to the public telecommunications network of terminal equipment that is not used in conformity with its intended purpose.
Article 4 Terminal equipment shall satisfy the following essential requirements:
(a)user safety, in so far as this requirement is not covered by Directive 73/23/EEC;
(b)safety of employees of public telecommunications networks operators, in so far as this requirement is not covered by Directive 73/23/EEC;
(c)electromagnetic compatibility requirements in so far as they are specific to terminal equipment;
(d)protection of the public telecommunications network from harm;
(e)effective use of the radio frequency spectrum, where appropriate;
(f)interworking of terminal equipment with public telecommunications network equipment for the purpose of establishing, modifying, charging for, holding and clearing real or virtual connection;
(g)interworking of terminal equipment via the public telecommunications network, in justified cases.
The cases where terminal equipment supports:
(i)reserved service according to Community law;
or
(ii)a service which the Council has decided that there should be Community-wide availability,
are considered as justified cases and the requirements concerning this interworking are determined in accordance with the procedure provided for in Article 14.
In addition, after consultation of representatives of the bodies referred to in Article 13 (3) and taking due account of the result of these consultations, the Commission may propose that this essential requirement is recognized as being justified for other terminal equipment in accordance with the procedure provided for in Article 14.
Article 5 Member States shall not impede the placing on the market and the free circulation and use on their territory of terminal equipment which complies with the provisions of this Directive.
Article 6 1. Member States shall presume compliance with the essential requirements referred to in Article 4 (a) and (b) in respect of terminal equipment which is in conformity with the national standards implementing the relevant harmonized standards, the references of which have been published in the Official Journal of the European Communities. Member States shall publish the references of such national standards.
2. The Commission shall, in accordance with the procedure laid down in Article 14, adopt:
-as a first step, the measure identifying the type of terminal equipment for which a common technical regulation is required, as well as the associated scope statement for that regulation, with a view to its transmission to the relevant standardization bodies,
-as a second step, once they have been prepared by the relevant standardization bodies, the corresponding harmonized standards, or parts thereof, implementing the essential requirements referred to in Article 4 (c) to (g) which shall be transformed into common technical regulations, compliance with which shall be mandatory and the reference of which shall be published in the Official Journal of the European Communities.
Article 7 Where a Member State or the Commission considers that the harmonized standards referred to in Article 6 exceed or
do not entirely meet the essential requirements referred to in Article 4, the Commission or the Member State concerned shall bring the matter before the Committee referred to in Article 13, hereinafter referred to as 'the Committee', giving the reasons therefor. The Committee shall deliver an opinion as soon as possible.
In the light of the Committee's opinion and after consultation of the standing Committee set up by Directive 83/189/EEC, the Commission shall inform the Member States whether or not it is necessary to withdraw reference to those standards and any related technical regulations from the Official Journal of the European Communities and shall take the necessary steps to correct the shortcomings noted in the standards.
Article 8 1. Where a Member State finds that terminal equipment bearing the markings under the provision laid down in Chapter III does not comply with the relevant essential requirements when properly used in accordance with the purpose intended by the manufacturer, it shall take all appropriate measures to withdraw such products from the market or to prohibit or restrict their being placed on the market.
The Member State concerned shall immediately inform the Commission of any such measure indicating the reasons for its decision, and in particular whether non-compliance is due to:
(a)incorrect application of the harmonized standards or common technical regulations referred to in Article 6;
(b)shortcomings in the harmonized standards or common technical regulations referred to in Article 6 themselves.
2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that any measure as referred to in paragraph 1 is justified it shall immediately so inform the Member State that took the action and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the harmonized standards or common technical regulations, the Commission, after consulting the parties concerned, shall bring the matter before the Committee within two months if the Member State which has taken the measure intends to maintain them, and shall initiate the procedure referred to in Article 7.
3. Where terminal equipment which does not comply with the relevant essential requirements bears the CE mark the competent Member State shall take appropriate action
against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.
4. The Commission shall keep the Member State informed of the progress and outcome of this procedure
CHAPTER II Conformity assessment Article 9
1. According to the choice of the manufacturer or his authorized representative established within the Community, terminal equipment shall be subject to either the EC type-examination, as described in Annex I, or to the EC delcaration of conformity, as described in Annex IV.
2. An EC type-examination as described in Annex I shall be accompanied by a declaration issued according to the EC declaration of conformity to type procedure as described in Annex II or Annex III.
3. The records and correspondence relating to the procedure referred to in this Article shall be in an official language of the Member State where the said procedure will be carried out, or in a language acceptable to the notified body involved
4. Article 10 (4) of Directive 89/336/EEC is hereby deleted.
Article 10 1. Member States shall notify to the Commission the bodies established in the Community and their identifying symbols, which they have designated for carrying out the certification, product checks, and associated surveillance tasks pertaining to the procedures referred to in Article 9. Member States shall apply the minimum criteria, set out in Annex V, for the designation of such bodies. Bodies that satisfy the criteria fixed by the relevant harmonized standards shall be presumed to satisfy the criteria set out in Annex V.
2. Member States shall inform the Commission of test laboratories established in the Community which they have designated for carrying out tests pertaining to the procedures referred to in Article 9. Notified bodies shall apply the criteria fixed by the appropriate parts of the
relevant harmonized standards for the designation of such laboratories.
3. The Commission shall publish the list of notified bodies and the list of test laboratories together with the tasks for which they have been designated in the Official Journal of the European Communities and shall ensure that this list is kept up to date.
4. A Member State has designated a notified body or a test laboratory under paragraph 1 or 2 shall annul the designation if the notified body or the test laboratory no longer meets the relevant cirteria for designation. It shall immediately inform the other Member States and the Commission accordingly and withdraw the notification. Where a Member State or the Commission considers that a notified body or a test laboratory designated by a Member State does not meet the relevant criteria the matter shall be brought before the Committee referred to in Article 13, which shall give its opinion within three months; in the light of the Committee's opinion the Commission shall inform the Member State concerned of any changes needed if that notified body or test laboratory is to retain its recognized status.
5. In order to facilitate the determination of conformity of terminal equipment with technical regulations and standards, the notified bodies shall recognize documentation issued by third country relevant bodies, when agreements between the Community and the third country concerned have been concluded on the basis of a mutually satisfactory understanding.
6. The notified bodies referred to in Article 10 (1), when issuing an EC type-examination certificate as referred to in Annex I, followed by the appropriate document referred to in Annex II or III, or a decision on quality assurance assessment as referred to in Annex IV, issue at the same time an administrative approval for the connection of the concerned terminal equipment to the public telecommunications network.
CHAPTER III CE mark of conformity and inscriptions Article 11
1. The marking of terminal equipment complying with this Directive shall consist of the CE mark consisting of the symbol 'CE', followed by the identifying symbol of the notified body responsible and a symbol indicating that the
equipment is intended and is suitable to be connected to the public telecommunications network. The CE mark and these two symbols are shown in Annex VI.
2. The affixing of marks which are likely to be confused with the marks of conformity specified in Annex VI shall be prohibited.
3. Terminal equipment shall be identified by the manufacturer by means of type, batch and/or serial numbers and by the name of the manufacturer and/or supplier responsible for placing it on the market.
4. Equipment manufacturers or suppliers who place on the market equipment as referred to in Article 2 shall affix the symbol specified in Annex VII in such a way that it follows the CE mark and visually forms an integral part of the total marking.
Article 12 Where it is established that the marking referred to in Article 11 (1) has been affixed to terminal equipment which:
-does not conform to an approved type,
-conforms to an approved type which does not meet the essential requirements applicable to it,
or, where the manufacturer has failed to fulfil his obligations under the relevant EC declaration of conformity,
the notified body shall withdraw the EC type-examination certificate referred to in Annex I, the EC quality system approval decision referred to in Annex III or the EC quality system approval decision as referred to in Annex IV, notwithstanding any decisions taken under Article 8.
CHAPTER IV Committee Article 13
1. The Commission shall be assisted by a Committee of an advisory nature composed of the representatives of the Member States and chaired by the representative of the Commission. The Committee shall be called the Approvals Committee for Terminal Equipment (ACTE).
2. The representative of the Commission shall submit to the Committee a draft of the measure to be taken. The Committee shall deliver its opinion on the draft, within a
time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account.
3. The Commission will periodically consult the representative of the telecommunications organizations, the consumers, the manufacturers, the service providers and trade unions and will inform the Committee on the outcome of such consultations, with a view to taking due account of the outcome.
Article 14 1. Notwithstanding Article 13 (1) and (2), the following procedure shall apply for matters covered by Articles 4 (g) and 6 (2).
2. The representative of the Commission shall submit to the Committee established in Article 13 a draft of the measures to be taken as referred to in Articles 4 (g) and 6 (2). The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
4. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measure to be taken. The Council shall act by qualified majority. If, within three months from the date of referral to it, the Council has not acted, the proposed measure shall be adopted by the Commission.
CHAPTER V Final and transitional provisions Article 15
The Commission shall draw up every second year a report on the implementation of this Directive, including progress on drawing up the relevant harmonized standards and on transforming them into technical regulations, as well as any problems that have arisen in the course of implementation. The report will also outline the activities of the Committee, and assess progress in achieving an open competitive market for termimal equipment at Community level consistent with the essential requirements referred to in Article 4.
Article 16 1. Directive 86/361/EEC is hereby repealed, with effect from 6 November 1992. References made to the repealed Directive shall be construed as being made to this Directive.
2. Notwithstanding paragraph 1 and Article 10 (2), Member States may designate as test laboratories such bodies which have been notified under Directive 86/361/EEC, without applying the criteria of Article 10 (2) for a period of 18 months after the effective date of repeal of Directive 86/361/EEC, it being understood that these laboratories will continue to observe the criteria for which they were notified.
3. Notwithstanding paragraph 1, any type approval granted by Member States in accordance with Directive 86/361/EEC may remain valid under the legislation of the Member States within the criteria of validity appropriate to the original approval.
4. Notwithstanding paragraph 1, measures adopted under Directive 86/361/EEC shall be submitted to the Committee under the procedure of Article 14 for possible transposition into common technical regulations.
Article 17 1. Member States shall take the measure necessary to comply with this Directive not later than 6 November 1992. They shall fortwith inform the Commission thereof.
When Member States adopt these measure, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall inform the Commission of the main provisions of domestic law which they adopt in the field governed by this Directive.
Article 18 This Directive is addressed to the Member States. | [
"UKSI19943129",
"UKSI19922423"
] |
31991L0269 | 1991 | Commission Directive 91/269/EEC of 30 April 1991 adapting to technical progress Council Directive 82/130/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to firedamp
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 82/130/EEC of 15 February 1982 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to firedamp (1) as last amended by Directive 88/35/EEC (2), and in particular Article 7 thereof,
Whereas in view of the present state of technical progress, it is now necessary to adapt the contents of the harmonized standards referred to in Annex A of Directive 82/130/EEC;
Whereas in view of experience gained since Directive 82/130/EEC was adopted, it seems appropriate to amend Annex C thereto;
Whereas in view of the nature of equipment mentioned above, it is necessary to provide for a transition period in order to allow for the industry to adapt to the amendments of standards;
Whereas the measures provided for in this Directive are in accordance with the opinion delivered by the Restricted Committee of the Safety and Health Commission for the Mining and other Extractive industries,
Article 1
Directive 82/130/EEC is hereby amended as follows:
1. Annexes A and C are replaced by Annexes A and C in the Annex to this Directive.
2. Annex B is amended in accordance with Annex B in the Annex to this Directive. Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1992 and shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Member States shall communicate to the Commission the text of the national measures which they adopt pursuant to this Directive.
2. However, until 31 December 2009, Member States shall continue to apply the measures provided for in Article 4 of Directive 82/130/EEC as regards the equipment for which conformity to the harmonized standards is attested by the certificate of conformity referred to in Article 8 of Directive 82/130/EEC, provided that this certificate was issued before 1 January 1993. Article 3
This Directive is addressed to the Member States. | [
"UKSI19912826"
] |
31991L0321 | 1991 | Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (1), and in particular Article 4 thereof,
Whereas the essential composition of the products in question must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data;
Whereas on the basis of these data the essential composition of infant formulae and follow-on formulae manufactured from cows' milk proteins and soya proteins alone or in a mixture can already be defined; whereas the same is not true for preparations based wholly or partly on other sources of protein; whereas for this reason specific rules for such products, if necessary, will therefore have to be adopted at a later date;
Whereas this Directive reflects current knowledge about these products; whereas any modification, to allow innovation based on scientific and technical progress, will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC;
Whereas because of the persons for which these products are intended it will be necessary to lay down microbiological criteria and maximum levels for contaminants; whereas given the complexity of the subject these will have to be adopted at a later stage;
Whereas infant formula is the only processed foodstuff which wholly satisfies the nutritional requirements of infants during the first four to six months of life; whereas in order to safeguard the health of such infants it is necessary to ensure that the only products marketed as suitable for such use during the period would be infant formulae;
Whereas pursuant to Article 7 (1) of Directive 89/398/EEC the products covered by this Directive are subject to the general rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (2), as last amended by Directive 89/395/EEC (3); whereas this Directive adopts and expands upon the additions and exceptions to those general rules, where it is appropriate, in order to promote and protect breast-feeding;
Whereas, in particular, the nature and destination of the products covered by this Directive require nutritional labelling for the energy value and principal nutrients they contain; whereas, on the other hand, the method of use must be specified in conformity with Article 3 (1) (8) and Article 10 (2) of Directive 79/112/EEC, in order to prevent inappropriate uses likely to be detrimental to the health of infants;
Whereas, pursuant to Article 2 (2) of Directive 79/112/EEC, and in order to supply objective and scientifically verified information, it is necessary to define the conditions under which claims about the particular composition of an infant formula are authorized;
Whereas, in an effort to provide better protection for the health of infants, the rules of composition, labelling and advertising laid down in this Directive should be in conformity with the principles and the aims of the International Code of Marketing of Breast-Milk Substitutes adopted by the 34th World Health Assembly, bearing in mind the particular legal and factual situations existing in the Community;
Whereas given the important role which information on infant feeding plays in choosing, by pregnant women and mothers of infants, the type of nourishment provided to their children, it is necessary for Member States to take appropriate measures in order that this information ensures an adequate use of the products in question and is not counter to the promotion of breast-feeding;
Whereas this Directive does not concern the conditions of sale of publications specializing in baby care and of scientific publications;
Whereas the Scientific Committee for Food, in accordance with Article 4 of Directive 89/398/EEC, has been consulted on the provisions liable to affect public health;
Whereas issues relating to products intended for export to third countries should be dealt with in a coherent and homogeneous manner in a separate measure;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
Article 1
1. This Directive is a specific Directive within the meaning of Article 4 of Directive 89/398/EEC and lays down compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health in the Community. It also provides for Member States to give effect to principles and aims of the International Code of Marketing of Breast-Milk Substitutes dealing with marketing, information and responsibilities of health authorities.
2. For the purposes of this Directive,
(a) 'infants' means children under the age of 12 months;
(b) 'young children' means children aged between one and three years;
(c) 'infant formulae' means foodstuffs intended for particular nutritional use by infants during the first four to six months of life and satisfying by themselves the nutritional requirements of this category of persons;
(d) 'follow-on formulae' means foodstuffs intended for particular nutritional use by infants aged over four months and constituting the principal liquid element in a progressively diversified diet of this category of persons.
Article 2
Member States shall ensure that the products referred to in Article 1 (2) (c) and (d) may be marketed within the Community only if they conform to the definitions and rules laid down in this Directive. No product other than infant formula may be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life.
Article 3
1. Infant formulae shall be manufactured from protein sources defined in the Annexes and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has been established by generally accepted scientific data.
2. Follow-on formulae shall be manufactured from protein sources defined in the Annexes and other food ingredients as the case may be whose suitability for particular nutritional use by infants aged over four months has been established by generally accepted scientific data.
3. The prohibitions and limitations on the use of food ingredients laid down in Annexes I and II shall be observed.
Article 4
1. Infant formulae must comply with the compositional criteria specified in Annex I.
2. Follow-on formulae must comply with the compositional criteria specified in Annex II.
3. In order to make infant formulae and follow-on formulae ready for use, nothing more shall be required, as the case may be, than the addition of water.
Article 5
1. Only the substances listed in Annex III may be used in the manufacture of infant formulae and follow-on formulae in order to satisfy the requirements on:
- mineral substances,
- vitamins,
- amino acids and other nitrogen compounds,
- other substances having a particular nutritional purpose.
The purity criteria for these substances shall be stipulated at a later stage.
2. The provisions relating to the use of additives in the manufacture of infant formulae and follow-on formulae shall be laid down in a Council directive. Article 6 1. Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants. Where necessary the maximum levels of any such substance shall be stipulated at a later date.
2. Microbiological criteria shall be established at a later date.
Article 7
1. The name under which the products covered by Article 1 (2) are sold shall be, respectively:
- in English:
'infant formula' and 'follow-on formula',
- in Danish:
'Modermaelkserstatning' and 'Tilskudsblanding',
- in German:
'Saeuglingsanfangsnahrung' and 'Folgenahrung',
- in Greek:
'Ðáñáóêaaýáóìá ãéá âñÝoeç » and 'Ðáñáóêaaýáóìá aeaaýôaañçò âñaaoeéêÞò çëéêssáò »,
- in Spanish:
'Preparado para lactentes' and 'Preparado de continuación',
- in French:
'Préparation pour nourrissons' and 'Préparation de suite',
- in Italian:
'Alimento per lattanti' and 'Alimento di proseguimento',
- in Dutch:
'Volledige zuigelingenvoeding' and 'Opvolgzuigelingenvoeding',
- in Portuguese:
'Fórmula para lactentes' and 'Fórmula de transiçao'.
However, the name of products manufactured entirely from cows' milk proteins, shall be respectively:
- in English:
'Infant milk' and 'follow-on milk',
- in Danish:
'Modermaelkserstatning udelukkende baseret paa maelk' and 'Tilskudsblanding udelukkende baseret paa maelk',
- in German:
'Saeuglingsmilchnahrung' and 'Folgemilch',
- in Greek:
'ÃUEëá ãéá âñÝoeç » and 'ÃUEëá aeaaýôaañçò âñaaoeéêÞò çëéêssáò »,
- in Spanish:
'Leche para lactentes' and 'Leche de continuación',
- in French:
'Lait pour nourrissons' and 'Lait de suite',
- in Italian:
'Latte per lattanti' and 'Latte di proseguimento',
- in Dutch:
'Volledige zuigelingenvoeding op basis van melk' or 'Zuigelingenmelk' and 'Opvolgmelk',
- in Portuguese:
'Leite para lactentes' and 'Leite de transiçao'.
2. The labelling shall bear, in addition to those provided for in Article 3 of Directive 79/112/EEC, the following mandatory particulars:
(a) in the case of infant formulae, a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breast-fed;
(b) in the case of infant formulae that do not contain added iron, a statement to the effect that, when the product is given to infants over the age of four months, their total iron requirements must be met from other additional sources;
(c) in the case of follow-on formulae, a statement to the effect that the product is suitable only for particular nutritional use by infants over the age of four months, that it should form only part of a diversified diet and that it is not to be used as a substitute for breast milk during the first four months of life;
(d) in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, lipids and carbohydrates per 100 ml of the product ready for use;
(e) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in Annexes I and II respectively, and where applicable of choline, inositol and carnitine, per 100 ml of the product ready for use;
(f) in the case of infant formulae and follow-on formulae, instructions for appropriate preparation of the product and a warning against the health hazards of inappropriate preparation.
3. The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast-feeding. The use of the terms 'humanized', 'maternalized', or similar terms shall be prohibited. The term 'adapted' may only be used in conformity with paragraph 6 and Annex IV, point 1.
4. The labelling of infant formulae shall in addition bear the following mandatory particulars, preceded by the words 'Important Notice' or their equivalent:
(a) a statement concerning the superiority of breast-feeding;
(b) a statement recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care;
5. The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealize the use of the product. It may, however, have graphic representations for easy identification of the product and for illustrating methods of preparation.
6. The labelling may bear claims concerning the special composition of an infant formula only in the cases listed in Annex IV and in accordance with the conditions laid down therein.
7. The requirements, prohibitions and restrictions referred to in paragraphs 3 to 6 shall also apply to:
(a) the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed;
(b) advertising.
Article 8
1. Advertising of infant formulae shall be restricted to publications specializing in baby care and scientific publications. Member States may further restrict or prohibit such advertising. Such advertisements for infant formulae shall be subject to the conditions laid down in Article 7 (3), (4), (5), (6) and (7) (b) and contain only information of a scientific and factual nature. Such information shall not imply or create a belief that bottle-feeding is equivalent or superior to breast-feeding.
2. There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formula directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales.
3. Manufacturers and distributors of infant formulae shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly via the health care system or health workers.
Article 9
1. Member States shall ensure that objective and consistent information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition covering the planning, provision, design and dissemination of information and their control.
2. Member States shall ensure that informational and educational materials, whether written or audiovisual, dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children, shall include clear information on all the following points:
(a) the benefits and superiority of breast-feeding;
(b) maternal nutrition and the preparation for and maintenance of breast-feeding;
(c) the possible negative effect on breast-feeding of introducing partial bottle-feeding;
(d) the difficulty of reversing the decision not to breast-feed;
(e) where needed, the proper use of infant formulae, whether manufactured industrially or home-prepared.
When such materials contain information about the use of infant formulae, they shall include the social and financial implications of its use; the health hazards of inappropriate foods or feeding methods, and, in particular, the health hazards of improper use of infant formulae. Such material shall not use any pictures which may idealize the use of infant formulae.
3. Member States shall ensure that donations of informational or educational equipment or materials by manufacturers or distributors shall be made only on request and with the written approval of the appropriate national authority or within guidelines given by that authority for this purpose. Such equipment or materials may bear the donating company's name or logo, but shall not refer to a proprietary brand of infant formulae and shall be distributed only through the health care system.
4. Member States shall ensure that donations or low-price sales of supplies of infant formulae to institutions or organizations, whether for use in the institutions or for distribution outside them, shall only be used by or distributed for infants who have to be fed on infant formulae and only for as long as required by such infants.
Article 10
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof. Those provisions shall be applied in such a way as to:
- permit trade in products complying with this Directive, by 1 December 1992,
- prohibit trade in products which do not comply with this Directive, with effect from 1 June 1994.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 11
This Directive is addressed to the Member States. | [
"UKSI19950077"
] |
31991L0250 | 1991 | Council Directive 91/250/EEC of 14 May 1991 on the legal protection of computer programs
Having regard to the Treaty establishing the European Economic Community and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas computer programs are at present not clearly protected in all Member States by existing legislation and such protection, where it exists, has different attributes;
Whereas the development of computer programs requires the investment of considerable human, technical and financial resources while computer programs can be copied at a fraction of the cost needed to develop them independently;
Whereas computer programs are playing an increasingly important role in a broad range of industries and computer program technology can accordingly be considered as being of fundamental importance for the Community's industrial development;
Whereas certain differences in the legal protection of computer programs offered by the laws of the Member States have direct and negative effects on the functioning of the common market as regards computer programs and such differences could well become greater as Member States introduce new legislation on this subject;
Whereas existing differences having such effects need to be removed and new ones prevented from arising, while differences not adversely affecting the functioning of the common market to a substantial degree need not be removed or prevented from arising;
Whereas the Community's legal framework on the protection of computer programs can accordingly in the first instance be limited to establishing that Member States should accord protection to computer programs under copyright law as literary works and, further, to establishing who and what should be protected, the exclusive rights on which protected persons should be able to rely in order to authorize or prohibit certain acts and for how long the protection should apply;
Whereas, for the purpose of this Directive, the term 'computer program` shall include programs in any form, including those which are incorporated into hardware; whereas this term also includes preparatory design work leading to the development of a computer program provided that the nature of the preparatory work is such that a computer program can result from it at a later stage;
Whereas, in respect of the criteria to be applied in determining whether or not a computer program is an original work, no tests as to the qualitative or aesthetic merits of the program should be applied;
Whereas the Community is fully committed to the promotion of international standardization;
Whereas the function of a computer program is to communicate and work together with other components of a computer system and with users and, for this purpose, a logical and, where appropriate, physical interconnection and interaction is required to permit all elements of software and hardware to work with other software and hardware and with users in all the ways in which they are intended to function;
Whereas the parts of the program which provide for such interconnection and interaction between elements of software and hardware are generally known as 'interfaces`;
Whereas this functional interconnection and interaction is generally known as 'interoperability`; whereas such interoperability can be defined as the ability to exchange information and mutually to use the information which has been exchanged;
Whereas, for the avoidance of doubt, it has to be made clear that only the expression of a computer program is protected and that ideas and principles which underlie any element of a program, including those which underlie its interfaces, are not protected by copyright under this Directive;
Whereas, in accordance with this principle of copyright, to the extent that logic, algorithms and programming languages comprise ideas and principles, those ideas and principles are not protected under this Directive;
Whereas, in accordance with the legislation and jurisprudence of the Member States and the international copyright conventions, the expression of those ideas and principles is to be protected by copyright;
Whereas, for the purposes of this Directive, the term 'rental` means the making available for use, for a limited period of time and for profit-making purposes, of a computer program or a copy thereof; whereas this term does not include public lending, which, accordingly, remains outside the scope of this Directive;
Whereas the exclusive rights of the author to prevent the unauthorized reproduction of his work have to be subject to a limited exception in the case of a computer program to allow the reproduction technically necessary for the use of that program by the lawful acquirer;
Whereas this means that the acts of loading and running necessary for the use of a copy of a program which has been lawfully acquired, and the act of correction of its errors, may not be prohibited by contract; whereas, in the absence of specific contractual provisions, including when a copy of the program has been sold, any other act necessary for the use of the copy of a program may be performed in accordance with its intended purpose by a lawful acquirer of that copy;
Whereas a person having a right to use a computer program should not be prevented from performing acts necessary to observe, study or test the functioning of the program, provided that these acts do not infringe the copyright in the program;
Whereas the unauthorized reproduction, translation, adaptation or transformation of the form of the code in which a copy of a computer program has been made available constitutes an infringement of the exclusive rights of the author;
Whereas, nevertheless, circumstances may exist when such a reproduction of the code and translation of its form within the meaning of Article 4 (a) and (b) are indispensable to obtain the necessary information to achieve the interoperability of an independently created program with other programs;
Whereas it has therefore to be considered that in these limited circumstances only, performance of the acts of reproduction and translation by or on behalf of a person having a right to use a copy of the program is legitimate and compatible with fair practice and must therefore be deemed not to require the authorization of the rightholder;
Whereas an objective of this exception is to make it possible to connect all components of a computer system, including those of different manufacturers, so that they can work together;
Whereas such an exception to the author's exclusive rights may not be used in a way which prejudices the legitimate interests of the rightholder or which conflicts with a normal exploitation of the program;
Whereas, in order to remain in accordance with the provisions of the Berne Convention for the Protection of Literary and Artistic Works, the term of protection should be the life of the author and fifty years from the first of January of the year following the year of his death or, in the case of an anonymous or pseudonymous work, 50 years from the first of January of the year following the year in which the work is first published;
Whereas protection of computer programs under copyright laws should be without prejudice to the application, in appropriate cases, of other forms of protection; whereas, however, any contractual provisions contrary to Article 6 or to the exceptions provided for in Article 5 (2) and (3) should be null and void;
Whereas the provisions of this Directive are without prejudice to the application of the competition rules under Articles 85 and 86 of the Treaty if a dominant supplier refuses to make information available which is necessary for interoperability as defined in this Directive;
Whereas the provisions of this Directive should be without prejudice to specific requirements of Community law already enacted in respect of the publication of interfaces in the telecommunications sector or Council Decisions relating to standardization in the field of information technology and telecommunication;
Whereas this Directive does not affect derogations provided for under national legislation in accordance with the Berne Convention on points not covered by this Directive,
Article 1 Object of protection
1. In accordance with the provisions of this Directive, Member States shall protect computer programs, by copyright, as literary works within the meaning of the Berne Convention for the Protection of Literary and Artistic Works. For the purposes of this Directive, the term 'computer programs` shall include their preparatory design material.
2. Protection in accordance with this Directive shall apply to the expression in any form of a computer program. Ideas and principles which underlie any element of a computer program, including those which underlie its interfaces, are not protected by copyright under this Directive.
3. A computer program shall be protected if it is original in the sense that it is the author's own intellectual creation. No other criteria shall be applied to determine its eligibility for protection.
Article 2 Authorship of computer programs
1. The author of a computer program shall be the natural person or group of natural persons who has created the program or, where the legislation of the Member State permits, the legal person designated as the rightholder by that legislation. Where collective works are recognized by the legislation of a Member State, the person considered by the legislation of the Member State to have created the work shall be deemed to be its author.
2. In respect of a computer program created by a group of natural persons jointly, the exclusive rights shall be owned jointly.
3. Where a computer program is created by an employee in the execution of his duties or following the instructions given by his employer, the employer exclusively shall be entitled to exercise all economic rights in the program so created, unless otherwise provided by contract.
Article 3 Beneficiaries of protection
Protection shall be granted to all natural or legal persons eligible under national copyright legislation as applied to literary works.
Article 4 Restricted Acts
Subject to the provisions of Articles 5 and 6, the exclusive rights of the rightholder within the meaning of Article 2, shall include the right to do or to authorize:
(a) the permanent or temporary reproduction of a computer program by any means and in any form, in part or in whole. Insofar as loading, displaying, running, transmision or storage of the computer program necessitate such reproduction, such acts shall be subject to authorization by the rightholder;
(b) the translation, adaptation, arrangement and any other alteration of a computer program and the reproduction of the results thereof, without prejudice to the rights of the person who alters the program;
(c) any form of distribution to the public, including the rental, of the original computer program or of copies thereof. The first sale in the Community of a copy of a program by the rightholder or with his consent shall exhaust the distribution right within the Community of that copy, with the exception of the right to control further rental of the program or a copy thereof.
Article 5 Exceptions to the restricted acts
1. In the absence of specific contractual provisions, the acts referred to in Article 4 (a) and (b) shall not require authorization by the rightholder where they are necessary for the use of the computer program by the lawful acquirer in accordance with its intended purpose, including for error correction.
2. The making of a back-up copy by a person having a right to use the computer program may not be prevented by contract insofar as it is necessary for that use.
3. The person having a right to use a copy of a computer program shall be entitled, without the authorization of the rightholder, to observe, study or test the functioning of the program in order to determine the ideas and principles which underlie any element of the program if he does so while performing any of the acts of loading, displaying, running, transmitting or storing the program which he is entitled to do.
Article 6 Decompilation
1. The authorization of the rightholder shall not be required where reproduction of the code and translation of its form within the meaning of Article 4 (a) and (b) are indispensable to obtain the information necessary to achieve the interoperability of an independently created computer program with other programs, provided that the following conditions are met:
(a) these acts are performed by the licensee or by another person having a right to use a copy of a program, or on their behalf by a person authorized to to so;
(b) the information necessary to achieve interoperability has not previously been readily available to the persons referred to in subparagraph (a); and (c) these acts are confined to the parts of the original program which are necessary to achieve interoperability.
2. The provisions of paragraph 1 shall not permit the information obtained through its application:
(a) to be used for goals other than to achieve the interoperability of the independently created computer program;
(b) to be given to others, except when necessary for the interoperability of the independently created computer program; or (c) to be used for the development, production or marketing of a computer program substantially similar in its expression, or for any other act which infringes copyright.
3. In accordance with the provisions of the Berne Convention for the protection of Literary and Artistic Works, the provisions of this Article may not be interpreted in such a way as to allow its application to be used in a manner which unreasonably prejudices the right holder's legitimate interests or conflicts with a normal exploitation of the computer program.
Article 7 Special measures of protection
1. Without prejudice to the provisions of Articles 4, 5 and 6, Member States shall provide, in accordance with their national legislation, appropriate remedies against a person committing any of the acts listed in subparagraphs (a), (b) and (c) below:
(a) any act of putting into circulation a copy of a computer program knowing, or having reason to believe, that it is an infringing copy;
(b) the possession, for commercial purposes, of a copy of a computer program knowing, or having reason to believe, that it is an infringing copy;
(c) any act of putting into circulation, or the possession for commercial purposes of, any means the sole intended purpose of which is to facilitate the unauthorized removal or circumvention of any technical device which may have been applied to protect a computer program.
2. Any infringing copy of a computer program shall be liable to seizure in accordance with the legislation of the Member State concerned.
3. Member States may provide for the seizure of any means referred to in paragraph 1 (c).
Article 8 Term of protection
1. Protection shall be granted for the life of the author and for fifty years after his death or after the death of the last surviving author; where the computer program is an anonymous or pseudonymous work, or where a legal person is designated as the author by national legislation in accordance with Article 2 (1), the term of protection shall be fifty years from the time that the computer program is first lawfully made available to the public. The term of protection shall be deemed to begin on the first of January of the year following the abovementioned events.
2. Member States which already have a term of protection longer than that provided for in paragraph 1 are allowed to maintain their present term until such time as the term of protection for copyright works is harmonized by Community law in a more general way.
Article 9 Continued application of other legal provisions
1. The provisions of this Directive shall be without prejudice to any other legal provisions such as those concerning patent rights, trade-marks, unfair competition, trade secrets, protection of semi-conductor products or the law of contract. Any contractual provisions contrary to Article 6 or to the exceptions provided for in Article 5 (2) and (3) shall be null and void.
2. The provisions of this Directive shall apply also to programs created before 1 January 1993 without prejudice to any acts concluded and rights acquired before that date.
Article 10 Final provisions
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993.
When Member States adopt these measures, the latter shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.
Article 11
This Directive is addressed to the Member States. | [
"UKSI19923233"
] |
31991L0271 | 1991 | Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment
Having regard to the Treaty establishing the European Economic Community, and in particular 130s thereof,
Having regard to the proposal from the Commission [1],
Having regard to the opinion of the European Parliament [2],
Having regard to the opinion of the Economic and Social Committee [3],
Whereas the Council Resolution of 28 June 1988 on the protection of the North Sea and of other waters in the Community [4] invited the Commission to submit proposals for measures required at Community level for the treatment of urban waste water;
Whereas pollution due to insufficient treatment of waste water in one Member State often influences other Member States' waters; whereas in accordance with Article 130r, action at Community level is necessary;
Whereas to prevent the environment from being adversely affected by the disposal of insufficiently-treated urban waste water, there is a general need for secondary treatment of urban waste water;
Whereas it is necessary in sensitive areas to require more stringent treatment; whereas in some less sensitive areas a primary treatment could be considered appropriate;
Whereas industrial waste water entering collecting systems as well as the discharge of waste water and disposal of sludge from urban waste water treatment plants should be subject to general rules or regulations and/or specific authorizations;
Whereas discharges from certain industrial sectors of biodegradable industrial waste water not entering urban waste water treatment plants before discharge to receiving waters should be subject to appropriate requirements;
Whereas the recycling of sludge arising from waste water treatment should be encouraged; whereas the disposal of sludge to surface waters should be phased out;
Whereas it is necessary to monitor treatment plants, receiving waters and the disposal of sludge to ensure that the environment is protected from the adverse effects of the discharge of waste waters;
Whereas it is important to ensure that information on the disposal of waste water and sludge is made available to the public in the form of periodic reports;
Whereas Member States should establish and present to the Commission national programmes for the implementation of this Directive;
Whereas a Committee should be established to assist the Commission on matters relating to the implementation of this Directive and to its adaptation to technical progress,
Article 1
This Directive concerns the collection, treatment and discharge of urban waste water and the treatment and discharge of waste water from certain industrial sectors.
The objective of the Directive is to protect the environment from the adverse effects of the abovementioned waste water discharges.
Article 2
For the purpose of this Directive:
1. "urban waste water" means domestic waste water or the mixture of domestic waste water with industrial waste water and/or run-off rain water;
2. "domestic waste water" means waste water from residential settlements and services which originates predominantly from the human metabolism and from household activities;
3. "industrial waste water" means any waste water which is discharged from premises used for carrying on any trade or industry, other than domestic waste water and run-off rain water;
4. "agglomeration" means an area where the population and/or economic activities are sufficiently concentrated for urban waste water to be collected and conducted to an urban waste water treatment plant or to a final discharge point;
5. "collecting system" means a system of conduits which collects and conducts urban waste water;
6. "1 p.e. (population equivalent)" means the organic biodegradable load having a five-day biochemical oxygen demand (BOD5) of 60 g of oxygen per day;
7. "primary treatment" means treatment of urban waste water by a physical and/or chemical process involving settlement of suspended solids, or other processes in which the BOD5 of the incoming waste water is reduced by at least 20 % before discharge and the total suspended solids of the incoming waste water are reduced by at least 50 %;
8. "secondary treatment" means treatment of urban waste water by a process generally involving biological treatment with a secondary settlement or other process in which the requirements established in Table 1 of Annex I are respected;
9. "appropriate treatment" means treatment of urban waste water by any process and/or disposal system which after discharge allows the receiving waters to meet the relevant quality objectives and the relevant provisions of this and other Community Directives;
10. "Sludge" means residual sludge, whether treated or untreated, from urban waste water treatment plants;
11. "eutrophication" means the enrichment of water by nutrients, especially compounds of nitrogen and/or phosphorus, causing an accelerated growth of algae and higher forms of plant life to produce an undesirable disturbance to the balance of organisms present in the water and to the quality of the water concerned;
12. "estuary" means the transitional area at the mouth of a river between fresh-water and coastal waters. Member States shall establish the outer (seaward) limits of estuaries for the purposes of this Directive as part of the programme for implementation in accordance with the provisions of Article 17 (1) and (2);
13. "coastal waters" means the waters outside the low-water line or the outer limit of an estuary.
Article 3
1. Member States shall ensure that all agglomerations are provided with collecting systems for urban waste water,
- at the latest by 31 December 2000 for those with a population equivalent (p.e.) of more than 15000, and
- at the latest by 31 December 2005 for those with a p.e. of between 2000 and 15000.
For urban waste water discharging into receiving waters which are considered "sensitive areas" as defined under Article 5, Member States shall ensure that collection systems are provided at the latest by 31 December 1998 for agglomerations of more than 10000 p.e.
Where the establishment of a collecting system is not justified either because it would produce no environmental benefit or because it would involve excessive cost, individual systems or other appropriate systems which achieve the same level of environmental protection shall be used.
2. Collecting systems described in paragraph 1 shall satisfy the requirements of Annex I (A). These requirements may be amended in accordance with the procedure laid down in Article 18.
Article 4
1. Member States shall ensure that urban waste water entering collecting systems shall before discharge be subject to secondary treatment or an equivalent treatment as follows:
- at the latest by 31 December 2000 for all discharges from agglomerations of more than 15000 p.e.,
- at the latest by 31 December 2005 for all discharges from agglomerations ofbetween 10000 and 15000 p.e.,
- at the latest by 31 December 2005 for discharges to fresh-water and estuaries from agglomerations of between 2000 and 10000 p.e.
2. Urban waste water discharges to waters situated in high mountain regions (over 1500 m above sea level) where it is difficult to apply an effective biological treatment due to low temperatures may be subjected to treatment less stringent than that prescribed in paragraph 1, provided that detailed studies indicate that such discharges do not adversely affect the environment.
3. Discharges from urban waste water treatment plants described in paragraphs 1 and 2 shall satisfy the relevant requirements of Annex I.B. These requirements may be amended in accordance with the procedure laid down in Article 18.
4. The load expressed in p.e. shall be calculated on the basis of the maximum average weekly load entering the treatment plant during the year, excluding unusual situations such as those due to heavy rain.
Article 5
1. For the purposes of paragraph 2, Member States shall by 31 December 1993 identify sensitive areas according to the criteria laid down in Annex II.
2. Member States shall ensure that urban waste water entering collecting systems shall before discharge into sensitive areas be subject to more stringent treatment than that described in Article 4, by 31 December 1998 at the latest for all discharges from agglomerations of more than 10000p.e.
3. Discharges from urban waste water treatment plants described in paragraph 2 shall satisfy the relevant requirements of Annex I B. These requirements may be amended in accordance with the procedure laid down in Article 18.
4. Alternatively, requirements for individual plants set out in paragraphs 2 and 3 above need not apply in sensitive areas where it can be shown that the minimum percentage of reduction of the overall load entering all urban waste water treatment plants in that area is at least 75 % for total phosphorus and at least 75 % for total nitrogen.
5. Discharges from urban waste water treatment plants which are situated in the relevant catchment areas of sensitive areas and which contribute to the pollution of these areas shall be subject to paragraphs 2, 3 and 4.
In cases where the above catchment areas are situated wholly or partly in another Member State Article 9 shall apply.
6. Member States shall ensure that the identification of sensitive areas is reviewed at intervals of no more than four years.
7. Member States shall ensure that areas identified as sensitive following review under paragraph 6 shall within seven years meet the above requirements.
8. A Member State does not have to identify sensitive areas for the purpose of this Directive if it implements the treatment established under paragraphs 2, 3 and 4 over all its territory.
Article 6
1. For the purposes of paragraph 2, Member States may by 31 December 1993 identify less sensitive areas according to the criteria laid down in Annex II.
2. Urban waste water discharges from agglomerations of between 10000 and 150000 p.e. to coastal waters and those from agglomaterions of between 2000 and 10000 p.e. to estuaries situated in areas described in paragraph 1 may be subjected to treatment less stringent than that prescribed in Article 4 providing that:
- such discharges receive at least primary treatment as defined in Article 2 (7) in conformity with the control procedures laid down in Annex I D,
- comprehensive studies indicate that such discharges will not adversely affect the environment.
Member States shall provide the Commission with all relevant information concerning the abovementioned studies.
3. If the Commission considers that the conditions set out in paragraph 2 are not met, it shall submit to the Council an appropriate proposal.
4. Member States shall ensure that the identification of less sensitive areas is reviewed at intervals of not more than four years.
5. Member States shall ensure that areas no longer identified as less sensitive shall within seven years meet the requirements of Articles 4 and 5 as appropriate.
Article 7
Member States shall ensure that, by 31 December 2005, urban waste water entering collecting systems shall before discharge be subject to appropriate treatment as defined in Article 2 (9) in the following cases:
- for discharges to fresh-water and estuaries from agglomerations of less than 2000 p.e.,
- for discharges to coastal waters from agglomerations of less than 10000 p.e.
Article 8
1. Member States may, in exceptional cases due to technical problems and for geographically defined population groups, submit a special request to the Commission for a longer period for complying with Article 4.
2. This request, for which grounds msut be duly put forward, shall set out the technical difficulties experienced and must propose an action programme with an appropriate timetable to be undertaken to implement the objective of this Directive. This timetable shall be included in the programme for implementation referred to in Article 17.
3. Only technical reasons can be accepted and the longer period referred to in paragraph 1 may not extend beyond 31 December 2005.
4. The Commission shall examine this request and take appropriate measures in accordance with the procedure laid down in Article 18.
5. In exceptional circumstances, when it can be demonstrated that more advanced treatment will not produce any environmental benefits, discharges into less sensitive areas of waste waters from agglomerations of more than 150000 p.e. may be subject to the treatment provided for in Article 6 for waste water from agglomerations of between 10000 and 150000 p.e.
In such circumstances, Member States shall submit beforehand the relevant documentation to the Commission. The Commission will examine the case and take appropriate measures in accordance with the procedure laid down in Article 18.
Article 9
Where waters within the area of jurisdiction of a Member State are adversely affected by discharges of urban waste water from another Member State, the Member State whose waters are affected may notify the other Member State and the Commission of the relevant facts.
The Member States concerned shall organize, where appropriate with the Commission, the concertation necessary to identify the discharges in question and the measures to be taken at source to protect the waters that are affected in order to ensure conformity with the provisions of this Directive.
Article 10
Member States shall ensure that the urban waste water treatment plants built to comply with the requirements of Articles 4, 5, 6 and 7 are designed, constructed, operated and maintained to ensure sufficient performance under all normal local climatic conditions. When designing the plants, seasonal variations of the load shall be taken into account.
Article 11
1. Member States shall ensure that, before 31 December 1993, the discharge of industrial waste water into collecting systems and urban waste water treatment plants is subject to prior regulations and/or specific authorizations by the competent authority or appropriate body.
2. Regulations and/or specific authorization shall satisfy the requirements of Annex I C. These requirements may be amended in accordance with the procedure laid down in Article 18.
3. Regulations and specific authorization shall be reviewed and if necessary adapted at regular intervals.
Article 12
1. Treated waste water shall be reused whenever appropriate. Disposal routes shall minimize the adverse effects on the environment.
2. Competent authorities or appropriate bodies shall ensure that the disposal of waste water from urban waste water treatment plants is subject to prior regulations and/or specific authorization.
3. Prior regulations and/or specific authorization of discharges from urban waste water treatment plants made pursuant to paragraph 2 within agglomerations of 2000 to 10000 p.e. in the case of discharges to fresh waters and estuaries, and of 10000p.e. or more in respect of all discharges, shall contain conditions to satisfy the relevant requirements of Annex I B. These requirements may be amended in accordance with the procedure laid down in Article 18.
4. Regulations and/or authorization shall be reviewed and if necessary adapted at regular intervals.
Article 13
1. Member States shall ensure that by 31 December 2000 biodegradable industrial waste water from plants belonging to the industrial sectors listed in Annex III which does not enter urban waste water treatment plants before discharge to receiving waters shall before discharge respect conditions established in prior regulations and/or specific authorization by the competent authority or appropriate body, in respect of all discharges from plants representing 4000 p.e. or more.
2. By 31 December 1993 the competent authority or appropriate body in each Member State shall set requirements appropriate to the nature of the industry concerned for the discharge of such waste water.
3. The Commission shall carry out a comparison of the Member States' requirements by 31 December 1994. It shall publish the results in a report and if necessary make an appropriate proposal.
Article 14
1. Sludge arising from waste water treatment shall be re-used whenever appropriate. Disposal routes shall minimize the adverse effects on the environment.
2. Competent authorities or appropriate bodies shall ensure that before 31 December 1998 the disposal of sludge from urban waste water treatment plants is subject to general rules or registration or authorization.
3. Member States shall ensure that by 31 December 1998 the disposal of sludge to surface waters by dumping from ships, by discharge from pipelines or by other means is phased out.
4. Until the elimination of the forms of disposal mentioned in paragraph 3, Member States shall ensure that the total amount of toxic, persistent or bioaccumulable materials in sludge disposed of to surface waters is licensed for disposal and progressively reduced.
Article 15
1. Competent authorities or appropriate bodies shall monitor:
- discharges from urba waste water treatment plants to verify compliance with the requirements of Annex I.B in accordance with the control procedures laid down in Annex I.D,
- amounts and composition of sludges disposed of to surface waters.
2. Competent authorities or appropriate bodies shall monitor waters subject to discharges from urban waste water treatment plants and direct discharges as described in Article 13 in cases where it can be expected that the receiving environment will be significantly affected.
3. In the case of a discharge subject to the provisions of Article 6 and in the case of disposal of sludge to surface waters, Member States shall monitor and carry out any other relevant studies to verify that the discharge or disposal does not adversely affect the environment.
4. Information collected by competent authorities or appropriate bodies in complying with paragraphs 1, 2 and 3 shall be retained in the Member State and made available to the Commission within six months of receipt of a request.
5. Guidelines on the monitoring referred to in paragraphs 1, 2 and 3 may be formulated in accordance with the procedure laid down in Article 18.
Article 16
Without prejudice to the implementation of the provisions of Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment [5], Member States shall ensure that every two years the relevant authorities or bodies publish situation reports on the disposal of urban waste water and sludge in their areas. These reports shall be transmitted to the Commission by the Member States as soon as they are published.
Article 17
1. Member States shall by 31 December 1993 establish a programme for the implementation of this Directive.
2. Member States shall by 30 June 1994 provide the Commission with information on the programme.
3. Member States shall, if necessary, provide the Commission by 30 June every two years with an update of the information described in paragraph 2.
4. The methods and formats to be adopted for reporting on the national programmes shall be determined in accordance with the procedure laid down in Article 18. Any amendments to these methods and formats shall be adopted in accordance with the same procedure.
5. The Commission shall every two years review and assess the information received pursuant to paragraphs 2 and 3 above and publish a report thereon.
Article 18
1. The Commission shall be assisted by a Committee composed of the representatives of the Member States and chaired by the representative of the Commission.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
(b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority.
Article 19
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 June 1993. They shall forthwith inform the Commission thereof.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
Article 20
This Directive is addressed to the Member States. | [
"UKSI19942841"
] |
31991L0322 | 1991 | COMMISSION DIRECTIVE of 29 May 1991 on establishing indicative limit values by implementing Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (91/322/EEC)
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (1), as last amended by Directive 88/642/EEC (2), and in particular the first subparagraph of Article 8 (4) thereof,
Having regard to the opinion of the Advisory Committee on Safety, Hygiene and Health Protection at Work,
Whereas the third subparagraph of Article 8 (4) of Directive 80/1107/EEC states that indicative limit values shall reflect expert evaluations based on scientific data;
Whereas the aim of fixing these values is the harmonization of conditions in this area, while maintaining the improvements made;
Whereas the Directive constitutes a practical step towards the achievement of the social dimension of the internal market;
Whereas occupational exposure limit values should be regarded as an important part of the overall approach to ensuring the protection of the health of workers at the workplace;
Whereas an initial list of occupational exposure limit values can be established for agents for which similar values exist in the Member States, giving priority to agents which are found at places of work and are likely to have an effect on the health of workers; whereas this list can be based on existing scientific data as far as the effects on health are concerned, although for certain agents these data are very limited;
Whereas in addition it may be necessary to establish occupational exposure limit values for shorter periods taking into account the effects arising from short term exposure;
Whereas a reference method covering, inter alia, assessment of exposure and measuring strategy for occupational exposure limit values is contained in Directive 80/1107/EEC;
Whereas, in view of the importance of obtaining reliable measurements of exposure in relation to occupational exposure limit values, it may be necessary in the future to establish appropriate reference methods;
Whereas occupational exposure limit values need to be kept under review and will need to be revised if new scientific data indicate that they are no longer valid;
Whereas, for some agents it will be necessary in the future to consider all absorption pathways, including the possibility of penetration through the skin, in order to ensure the best possible level of protection;
Whereas the measures laid down in this Directive are in conformity with the opinion of the Committee set up pursuant to Article 9 of Directive 80/1107/EEC,
Article 1
Indicative limit values, of which Member States shall take account, inter alia, when establishing the limit values referred to in Article 4 (4) (b) of Directive 80/1107/EEC are listed in the Annex.
Article 2
1. Member States shall bring into force the provisions necessary to comply with this Directive by 31 December 1993. They shall immediately inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19881657"
] |
31991L0296 | 1991 | Council Directive 91/296/EEC of 31 May 1991 on the transit of natural gas through grids
Having regad to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas it is necessary to adopt measures with the aim of progressively establishing the internal market during the period ending 31 December 1992; whereas successive European Councils have recognized the need for a single internal market and, particularly in Rhodes, the need for a single energy market;
Whereas completion of the internal market in energy in general, and more particularly in the natural gas sector, requires the development of a Community energy strategy that will be equal to the challenges of:
- security of supply,
- environmental protection;
Whereas there must be greater integration of the European energy market if the single internal market is to be achieved; whereas natural gas is an essential component of the Community's energy balance;
Whereas greater reliance on natural gas is desirable as part of diversification of energy sources;
Whereas the completion of the internal market for energy, more particularly in the natural gas sector, will take into account the objective of economic and social cohesion;
Whereas the objective of the internal natural gas market is to ensure greater profitability, compatibility with the environment and security of supplies by free trade, without unacceptable restrictions on competition; whereas the specific characteristics of the natural gas sector must be taken into account if the pursuit of this objective is to be successful;
Whereas in completing the internal market in natural gas, consideration should be given not only to comparable features in the Member States but equally to sometimes significant differences;
Whereas trade in natural gas between the high-pressure gas transmission grids of European countries is increasing from year to year and has implications in terms of investment; whereas the Community's security of natural gas supply could be improved and costs reduced by operating the interconnections required for such trade;
Whereas the exchange of natural gas between high-pressure gas transmission grids is being conducted on such a scale that the transactions requested and their consequences should be systematically known to the Commission;
Whereas it is possible and desirable to increase natural gas transfers between grids and also take account of the imperatives of security and quality of natural gas supply; whereas studies show that greater natural gas transfers between grids can minimize the cost of investment;
Whereas in the future additional interconnections between several Member States will need to be made to allow adequate supplies;
Whereas increased natural gas transfers between grids would also encourage cooperation between natural gas transmission companies to find ways of improving natural gas transmission equipment; whereas such improvements will also cut costs;
Whereas there are still obstacles to increased trade in natural gas between grids; whereas, provided that they are not due to the nature of the technology used or of the grids themselves, such obstacles can be reduced by making the transit of natural gas through grids compulsory and introducing an appropriate system for monitoring compliance with this obligation;
Whereas this obligation and monitoring system concern the transit of natural gas involved in trade which is in the Community interest, namely transit through high-pressure grids;
Whereas the financial, technical and legal conditions of such transit must, as a general rule, be worked out directly between the grids concerned;
Whereas the conditions of transit should be fair and should not bring about, directly or indirectly, conditions contrary to Community competition rules;
Whereas, in order to facilitate the conclusion of transit contracts, the Commission is providing for a conciliation procedure to be set up under which submission will be compulsory at the request of one of the parties, without the result of that procedure producing a legally binding effect;
Whereas it is necessary to approximate the provisions adopted by the Member States which affect the transit of natural gas;
Whereas the establishment of an internal natural gas market will stimulate the gradual dynamic integration of national natural gas grids; whereas in this context special infrastructure measures would held to accelerate the linking-up of outlying areas and islands in the Community to the overall interconnected grid;
Whereas the interconnection of European grids extends over a geographical territory which does not coincide with the Community's frontiers: whereas there is an obvious advantage in seeking cooperation with third countries involved in the interconnected European grid,
Article 1
Member States shall take the measures necessary to facilitate transit of natural gas between high-pressure transmission grids in accordance with the conditions laid down in this Directive. Article 2
1. Every transaction for the transport of natural gas under the following conditions shall constitute transit of natural gas between grids, for the purpose of this Directive, without prejudice to any special agreements concluded between the Community and third countries:
(a) transmission is carried out by the entity or entities responsible in each Member State for high-pressure natural gas grids, with the exception of distribution grids, in a Member State's territory which contribute to the efficent operation of European high-pressure interconnections;
(b) the grid of origin or final destination is situated in the Community;
(c) this transport involves the crossing of at least one intra-Community frontier.
2. The high-pressure natural gas transmission grids and the entities responsible for them in the Member States, which are listed in the Annex, shall be covered by this Directive. This list shall be updated by the Commission, after consultation with the Member State concerned, whenever necessary within the context of the objectives of this Directive and in particular taking into account paragraph 1 (a). Article 3
1. Contracts involving transit of natural gas between grids shall be negotiated between the entities responsible for those grids and for the quality of service provided and, where appropriate, with the entities responsible in the Member States for importing and exporting natural gas.
2. The conditions of transit shall, pursuant to the rules of the Treaty, be non-discriminatory and fair for all parties concerned, shall not include unfair clauses or unjustified restrictions and not endanger security of supply nor quality of service, in particular taking full account of the utilization of reserve production and storage capacity and the most efficient operation of existing systems.
3. Member States shall taken the measures necessary to ensure that the entities under their jurisdiction referred to in the Annex act without delay to:
- notify the Commission and the national authorities concerned of any request for transit;
- open negotiations on the conditions of the natural gas transit requested;
- inform the Commission and the national authorities concerned of the conclusion of a transit contract;
- inform the Commission and the national authorities concerned of the reasons for the failure of the negotiations to result in the conclusion of a contract within twelve months following communication of the request.
4. Each of the entities concerned may request that the conditions of transit be subject to conciliation by a body, set up and chaired by the Commission on which the entities responsible for grids in the Community are represented. Article 4
If the reasons for the absence of agreement on a request for transit appear unjustified or insufficient, the Commission, acting on a complaint from the requesting body or on its own initiative, shall implement the procedures provided for by Community law. Article 5
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1992. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 6
This Directive is addressed to the Member States. | [
"UKSI19921190"
] |
31991L0334 | 1991 | Commission Directive 91/334/EEC of 6 June 1991 amending Directive 82/475/EEC laying down the categories of ingredients which may be used for the purposes of labelling compound feedingstuffs for pet animals
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs ( 1 ), as last amended by Directive 90/44/EEC ( 2 ), and in particular Article 10 thereof,
Whereas, as regards labelling, the purpose of Directive 79/373/EEC is to ensure objective and accurate information as to the composition and use of feedingstuffs;
Whereas the declaration of the ingredients in feedingstuffs constitutes, in certain cases, an important item of information;
Whereas it has proved necessary to create categories making it possible to group under a single name several ingredients;
Whereas special provisions are needed for the labelling of feedingstuffs for pets to allow for the special character of this kind of feedingstuff;
Whereas Directive 90/44/EEC has amended the basic provisions relating to the labelling of compound feedingstuffs; whereas it is necessary to adapt Commission Directive 82/475/EEC ( 3 ) accordingly;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs,
Article 1
Article 1 of Directive 82/475/EEC is hereby replaced by the following :
"Article 1
Where, pursuant to Article 5c ( 3 ) of Directive 79/373/EEC, the indication of the specific name of the ingredient can be replaced by the name of the category to which the ingredient belongs, only the categories listed in the Annex hereto may be indicated on the packaging, container or label of compound feedingstuffs for pet animals .'
Article 2
Member States shall bring into force not later than 22 January 1992 the laws, regulations and administrative provisions necessary to comply with this Directive . They shall immediately inform the Commission thereof .
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication . The procedure for such reference shall be adopted by Member States .
Article 3
This Directive is addressed to the Member States . | [
"UKSI19912840"
] |
31991L0336 | 1991 | Commission Directive 91/336/EEC of 10 June 1991 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 91/249/EEC (2), and in particular Article 7 thereof,
Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientifc and technical knowledge;
Whereas the preservative 'Propane-1,2-diol' no longer appears to meet all the requirements necessary for its maintenance in the list of additives authorized throughout the Community as far as it is used as an additive in feedingstuffs for cats;
Whereas, therefore, the use of this substance in feedingstuffs for cats should prohibited;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,
Article 1
Annex I to Directive 70/524/EEC is hereby amended as set out in the Annex hereto.
Article 2
The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of Article 1 by 30 November 1991 at the latest. They shall immediately inform the Commission thereof.
When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of marking such a reference shall be laid down by the Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19912840"
] |
31991L0308 | 1991 | Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering
Having regard to the Treaty establishing the European Economic Community, and in particular Article 57 (2), first and third sentences, and Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas when credit and financial institutions are used to launder proceeds from criminal activities (hereinafter referred to as 'money laundering`), the soundness and stability of the institution concerned and confidence in the financial system as a whole could be seriously jeopardized, thereby losing the trust of the public;
Whereas lack of Community action against money laundering could lead Member States, for the purpose of protecting their financial systems, to adopt measures which could be inconsistent with completion of the single market; whereas, in order to facilitate their criminal activities, launderers could try to take advantage of the freedom of capital movement and freedom to supply financial services which the integrated financial area involves, if certain coordinating measures are not adopted at Community level;
Whereas money laundering has an evident influence on the rise of organized crime in general and drug trafficking in particular; whereas there is more and more awareness that combating money laundering is one of the most effective means of opposing this form of criminal activity, which constitutes a particular threat to Member States' societies;
Whereas money laundering must be combated mainly by penal means and within the framework of international cooperation among judicial and law enforcement authorities, as has been undertaken, in the field of drugs, by the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, adopted on 19 December 1988 in Vienna (hereinafter referred to as the 'Vienna Convention`) and more generally in relation to all criminal activities, by the Council of Europe Convention on laundering, tracing, seizure and confiscation of proceeds of crime, opened for signature on 8 November 1990 in Strasbourg;
Whereas a penal approach should, however, not be the only way to combat money laundering, since the financial system can play a highly effective role; whereas reference must be made in this context to the recommendation of the Council of Europe of 27 June 1980 and to the declaration of principles adopted in December 1988 in Basle by the banking supervisory authorities of the Group of Ten, both of which constitute major steps towards preventing the use of the financial system for money laundering;
Whereas money laundering is usually carried out in an international context so that the criminal origin of the funds can be better disguised; whereas measures exclusively adopted at a national level, without taking account of international coordination and cooperation, would have very limited effects;
Whereas any measures adopted by the Community in this field should be consistent with other action undertaken in other international fora; whereas in this respect any Community action should take particular account of the recommendations adopted by the financial action task force on money laundering, set up in July 1989 by the Paris summit of the seven most developed countries;
Whereas the European Parliament has requested, in several resolutions, the establishment of a global Community programme to combat drug trafficking, including provisions on prevention of money laundering;
Whereas for the purposes of this Directive the definition of money laundering is taken from that adopted in the Vienna Convention; whereas, however, since money laundering occurs not only in relation to the proceeds of drug-related offences but also in relation to the proceeds of other criminal activities (such as organized crime and terrorism), the Member States should, within the meaning of their legislation, extend the effects of the Directive to include the proceeds of such activities, to the extent that they are likely to result in laundering operations justifying sanctions on that basis;
Whereas prohibition of money laundering in Member States' legislation backed by appropriate measures and penalties is a necessary condition for combating this phenomenon;
Whereas ensuring that credit and financial institutions require identification of their customers when entering into business relations or conducting transactions, exceeding certain thresholds, are necessary to avoid launderers' taking advantage of anonymity to carry out their criminal activities; whereas such provisions must also be extended, as far as possible, to any beneficial owners;
Whereas credit and financial institutions must keep for at least five years copies or references of the identification documents required as well as supporting evidence and records consisting of documents relating to transactions or copies thereof similarly admissible in court proceedings under the applicable national legislation for use as evidence in any investigation into money laundering;
Whereas ensuring that credit and financial institutions examine with special attention any transaction which they regard as particularly likely, by its nature, to be related to money laundering is necessary in order to preserve the soundness and integrity of the financial system as well as to contribute to combating this phenomenon; whereas to this end they should pay special attention to transactions with third countries which do not apply comparable standards against money laundering to those established by the Community or to other equivalent standards set out by international fora and endorsed by the Community;
Whereas, for those purposes, Member States may ask credit and financial institutions to record in writing the results of the examination they are required to carry out and to ensure that those results are available to the authorities responsible for efforts to eliminate money laundering;
Whereas preventing the financial system from being used for money laundering is a task which cannot be carried out by the authorities responsible for combating this phenomenon without the cooperation of credit and financial institutions and their supervisory authorities; whereas banking secrecy must be lifted in such cases; whereas a mandatory system of reporting suspicious transactions which ensures that information is transmitted to the abovementioned authorities without alerting the customers concerned, is the most effective way to accomplish such cooperation; whereas a special protection clause is necessary to exempt credit and financial institutions, their employees and their directors from responsibility for breaching restrictions on disclosure of information;
Whereas the information received by the authorities pursuant to this Directive may be used only in connection with combating money laundering; whereas Member States may nevertheless provide that this information may be used for other purposes;
Whereas establishment by credit and financial institutions of procedures of internal control and training programmes in this field are complementary provisions without which the other measures contained in this Directive could become ineffective;
Whereas, since money laundering can be carried out not only through credit and financial institutions but also through other types of professions and categories of undertakings, Member States must extend the provisions of this Directive in whole or in part, to include those professions and undertakings whose activities are particularly likely to be used for money laundering purposes;
Whereas it is important that the Member States should take particular care to ensure that coordinated action is taken in the Community where there are strong grounds for believing that professions or activities the conditions governing the pursuit of which have been harmonized at Community level are being used for laundering money;
Whereas the effectiveness of efforts to eliminate money laundering is particularly dependent on the close coordination and harmonization of national implementing measures; whereas such coordination and harmonization which is being carried out in various international bodies requires, in the Community context, cooperation between Member States and the Commission in the framework of a contact committee;
Whereas it is for each Member State to adopt appropriate measures and to penalize infringement of such measures in an appropriate manner to ensure full application of this Directive,
Article 1
For the purpose of this Directive:
- 'credit institution` means a credit institution, as defined as in the first indent of Article 1 of Directive 77/780/EEC (4), as last amended by Directive 89/646/EEC (5), and includes branches within the meaning of the third indent of that Article and located in the Community, of credit institutions having their head offices outside the Community,
- 'financial institution` means an undertaking other than a credit institution whose principal activity is to carry out one or more of the operations included in numbers 2 to 12 and number 14 of the list annexed to Directive 89/646/EEC, or an insurance company duly authorized in accordance with Directive 79/267/EEC (6), as last amended by Directive 90/619/EEC (7), in so far as it carries out activities covered by that Directive; this definition includes branches located in the Community of financial institutions whose head offices are outside the Community,
- 'money laundering` means the following conduct when committed intentionally:
- the conversion or transfer of property, knowing that such property is derived from criminal activity or from an act of participation in such activity, for the purpose of concealing or disguising the illicit origin of the property or of assisting any person who is involved in the commission of such activity to evade the legal consequences of his action,
- the concealment or disguise of the true nature, source, location, disposition, movement, rights with respect to, or ownership of property, knowing that such property is derived from criminal activity or from an act of participation in such activity,
- the acquisition, possession or use of property, knowing, at the time of receipt, that such property was derived from criminal activity or from an act of participation in such activity,
- participation in, association to commit, attempts to commit and aiding, abetting, facilitating and counselling the commission of any of the actions mentioned in the foregoing paragraphs.
Knowledge, intent or purpose required as an element of the abovementioned activities may be inferred from objective factual circumstances.
Money laundering shall be regarded as such even where the activities which generated the property to be laundered were perpetrated in the territory of another Member State or in that of a third country.
- 'Property` means assets of every kind, whether corporeal or incorporeal, movable or immovable, tangible or intangible, and legal documents or instruments evidencing title to or interests in such assets.
- 'Criminal activity` means a crime specified in Article 3 (1) (a) of the Vienna Convention and any other criminal activity designated as such for the purposes of this Directive by each Member State.
- 'Competent authorities` means the national authorities empowered by law or regulation to supervise credit or financial institutions.
Article 2
Member States shall ensure that money laundering as defined in this Directive is prohibited.
Article 3
1. Member States shall ensure that credit and financial institutions require identification of their customers by means of supporting evidence when entering into business relations, particularly when opening an account or savings accounts, or when offering safe custody facilities.
2. The identification requirement shall also apply for any transaction with customers other than those referred to in paragraph 1, involving a sum amounting to ECU 15 000 or more, whether the transaction is carried out in a single operation or in several operations which seem to be linked. Where the sum is not known at the time when the transaction is undertaken, the institution concerned shall proceed with identification as soon as it is apprised of the sum and establishes that the threshold has been reached.
3. By way of derogation from paragraphs 1 and 2, the identification requirements with regard to insurance policies written by insurance undertakings within the meaning of Directive 79/267/EEC, where they perform activities which fall within the scope of that Directive shall not be required where the periodic premium amount or amounts to be paid in any given year does or do not exceed ECU 1 000 or where a single premium is paid amounting to ECU 2 500 or less. If the periodic premium amount or amounts to be paid in any given year is or are increased so as to exceed the ECU 1 000 threshold, identification shall be required.
4. Member States may provide that the identification requirement is not compulsory for insurance policies in respect of pension schemes taken out by virtue of a contract of employment or the insured's occupation, provided that such policies contain no surrender clause and may not be used as collateral for a loan.
5. In the event of doubt as to whether the customers referred to in the above paragraphs are acting on their own behalf, or where it is certain that they are not acting on their own behalf, the credit and financial institutions shall take reasonable measures to obtain information as to the real identity of the persons on whose behalf those customers are acting.
6. Credit and financial institutions shall carry out such identification, even where the amount of the transaction is lower than the threshold laid down, wherever there is suspicion of money laundering.
7. Credit and financial institutions shall not be subject to the identification requirements provided for in this Article where the customer is also a credit or financial institution covered by this Directive.
8. Member States may provide that the identification requirements regarding transactions referred to in paragraphs 3 and 4 are fulfilled when it is established that the payment for the transaction is to be debited from an account opened in the customer's name with a credit institution subject to this Directive according to the requirements of paragraph 1.
Article 4
Member States shall ensure that credit and financial institutions keep the following for use as evidence in any investigation into money laundering:
- in the case of identification, a copy or the references of the evidence required, for a period of at least five years after the relationship with their customer has ended,
- in the case of transactions, the supporting evidence and records, consisting of the original documents or copies admissible in court proceedings under the applicable national legislation for a period of at least five years following execution of the transactions.
Article 5
Member States shall ensure that credit and financial institutions examine with special attention any transaction which they regard as particularly likely, by its nature, to be related to money laundering.
Article 6
Member States shall ensure that credit and financial institutions and their directors and employees cooperate fully with the authorities responsible for combating money laundering:
- by informing those authorities, on their own initiative, of any fact which might be an indication of money laundering,
- by furnishing those authorities, at their request, with all necessary information, in accordance with the procedures established by the applicable legislation.
The information referred to in the first paragraph shall be forwarded to the authorities responsible for combating money laundering of the Member State in whose territory the institution forwarding the information is situated. The person or persons designated by the credit and financial institutions in accordance with the procedures provided for in Article 11 (1) shall normally forward the information.
Information supplied to the authorities in accordance with the first paragraph may be used only in connection with the combating of money laundering. However, Member States may provide that such information may also be used for other purposes.
Article 7
Member States shall ensure that credit and financial institutions refrain from carrying out transactions which they know or suspect to be related to money laundering until they have apprised the authorities referred to in Article 6. Those authorities may, under conditions determined by their national legislation, give instructions not to execute the operation. Where such a transaction is suspected of giving rise to money laundering and where to refrain in such manner is impossible or is likely to frustrate efforts to pursue the beneficiaries of a suspected money-laundering operation, the institutions concerned shall apprise the authorities immediately afterwards.
Article 8
Credit and financial institutions and their directors and employees shall not disclose to the customer concerned nor to other third persons that information has been transmitted to the authorities in accordance with Articles 6 and 7 or that a money laundering investigation is being carried out.
Article 9
The disclosure in good faith to the authorities responsible for combating money laundering by an employee or director of a credit or financial institution of the information referred to in Articles 6 and 7 shall not constitute a breach of any restriction on disclosure of information imposed by contract or by any legislative, regulatory or administrative provision, and shall not involve the credit or financial institution, its directors or employees in liability of any kind.
Article 10
Member States shall ensure that if, in the course of inspections carried out in credit or financial institutions by the competent authorities, or in any other way, those authorities discover facts that could constitute evidence of money laundering, they inform the authorities responsible for combating money laundering.
Article 11
Member States shall ensure that credit and financial institutions:
1. establish adequate procedures of internal control and communication in order to forestall and prevent operations related to money laundering,
2. take appropriate measures so that their employees are aware of the provisions contained in this Directive. These measures shall include participation of their relevant employees in special training programmes to help them recognize operations which may be related to money laundering as well as to instruct them as to how to proceed in such cases.
Article 12
Member States shall ensure that the provisions of this Directive are extended in whole or in part to professions and to categories of undertakings, other than the credit and financial institutions referred to in Article 1, which engage in activities which are particularly likely to be used for money-laundering purposes.
Article 13
1. A contact committee (hereinafter referred to as 'the Committee`) shall be set up under the aegis of the Commission. Its function shall be:
(a) without prejudice to Articles 169 and 170 of the Treaty, to facilitate harmonized implementation of this Directive through regular consultation on any practical problems arising from its application and on which exchanges of view are deemed useful;
(b) to facilitate consultation between the Member States on the more stringent or additional conditions and obligations which they may lay down at national level;
(c) to advise the Commission, if necessary, on any supplements or amendments to be made to this Directive or on any adjustments deemed necessary, in particular to harmonize the effects of Article 12;
(d) to examine whether a profession or a category of undertaking should be included in the scope of Article 12 where it has been established that such profession or category of undertaking has been used in a Member State for money laundering.
2. It shall not be the function of the Committee to appraise the merits of decisions taken by the competent authorities in individual cases.
3. The Committee shall be composed of persons appointed by the Member States and of representatives of the Commission. The secretariat shall be provided by the Commission. The chairman shall be a representative of the Commission. It shall be convened by its chairman, either on his own initiative or at the request of the delegation of a Member State.
Article 14
Each Member State shall take appropriate measures to ensure full application of all the provisions of this Directive and shall in particular determine the penalties to be applied for infringement of the measures adopted pursuant to this Directive.
Article 15
The Member States may adopt or retain in force stricter provisions in the field covered by this Directive to prevent money laundering.
Article 16
1. Member States shall bring into force the laws, regulations and administrative decisions necessary to comply with this Directive before 1 January 1993 at the latest.
2. Where Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.
Article 17
One year after 1 January 1993, whenever necessary and at least at three yearly intervals thereafter, the Commission shall draw up a report on the implementation of this Directive and submit it to the European Parliament and the Council.
Article 18
This Directive is addressed to the Member States. | [
"UKSI19931933"
] |
31991L0357 | 1991 | Commission Directive 91/357/EEC of 13 June 1991 laying down the categories of ingredients which may be used for the purposes of labelling compound feedingstuffs for animals other than pet animals
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (1), as last amended by Directive 90/44/EEC (2), and in particular Article 10 (a) thereof,
Whereas, as regards labelling, the purpose of Directive 79/373/EEC is to ensure that stock farmers are informed objectively and as accurately as possible as to the composition and use of feedingstuffs;
Whereas the quantitative determination of the ingredients in feedingstuffs for production animals currently raises verification difficulties, mainly because of the nature of the products used, of the complexity of the mixtures made or the manufacturing methods adopted;
Whereas it is accordingly appropriate at this stage to prefer, at least for feedingstuffs for production animals, a flexible declaration arrangement confined to the indication of the feedingstuff ingredients without stating their quantity; whereas it has furthermore proved necessary to provide for the establishment of categories making it possible to group several ingredients under a single name;
Whereas it is provided by Directive 79/373/EEC that in the light of advances in scientific knowledge categories grouping several ingredients shall be established not later than 22 January 1991;
Whereas, since categories of ingredients have already been established by Commission Directive 82/475/EEC (3) for compound feedingstuffs intended for pets, similar provisions should be adopted for feedingstuffs intended for other animals, within the meaning of Directive 79/373/EEC, than pet animals;
Whereas, however, it is not possible to establish categories covering all the ingredients of compound feedingstuffs; whereas, therefore, the manufacturer should indicate in addition any ingredients not belonging to any of the categories listed in the Annex;
Whereas the ingredients in category 12 'Land animal products' must, moreover, comply with the provisions of Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedingstuffs of animal or fish origin and amending Directive 90/425/EEC (4);
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs,
Article 1
Where, pursuant to Article 5 (c) (3) of Directive 79/373/EEC, the indication of the specific name of the ingredient may be replaced by the name of the category to which the ingredient belongs, only the categories listed in the Annex hereto may be indicated on the packaging, container or label of compound feedingstuffs for animals other than pet animals.
Article 2
Member States shall bring into force not later than 22 January 1992 the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive. They shall immediately inform the Commission thereof.
When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19912840"
] |
31991L0356 | 1991 | Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (1), as last amended by Directive 89/381/EEC (2), and in particular Article 19a thereof,
Whereas all medicinal products for human use manufactured or imported into the Community, including medicinal products intended for export, should be manufactured in accordance with the principles and guidelines of good manufacturing practice;
Whereas, in accordance with national legislation, Member States may require compliance with these principles of good manufacturing practice during the manufacture of products intended for use in clinical trials;
Whereas the detailed guidelines mentioned in Article 19a of Directive 75/319/EEC have been published by the Commission after consultation with the pharmaceutical inspection services of the Member States in the form of a 'Guide to good manufacturing practice for medicinal products';
Whereas it is necessary that all manufacturers should operate an effective quality management of their manufacturing operations, and that this requires the implementation of a pharmaceutical quality assurance system;
Whereas officials representing the competent authorities should report on whether the manufacturer complies with good manufacturing practice and that these reports should be communicated upon reasoned request to the competent authorities of another Member State;
Whereas the principles and guidelines of good manufacturing practice should primarily concern personnel, premises and equipment, documentation, production, quality control, contracting out, complaints and product recall, and self inspection;
Whereas the principles and guidelines envisaged by this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medicinal Products Sector set up by Article 2b of Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (3), as last amended by Directive 89/341/EEC (4),
CHAPTER I GENERAL PROVISIONS
Article 1
This Directive lays down the principles and guidelines of good manufacturing practice for medicinal products for human use whose manufacture requires the authorization referred to in Article 16 of Directive 75/319/EEC.
Article 2
For the purposes of this Directive, the definition of medicinal products set out in Article 1 (2) of Council Directive 65/65/EEC (5), shall apply.
In addition,
- 'manufacturer' shall mean any holder of the authorization referred to in Article 16 of Directive 75/319/EEC,
- 'qualified person' shall mean the person referred to in Article 21 of Directive 75/319/EEC,
- 'pharmaceutical quality assurance' shall mean the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use,
- 'good manufacturing practice' shall mean the part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
Article 3
By means of the repeated inspections referred to in Article 26 of Directive 75/319/EEC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive.
For the interpretation of these principles and guidelines of good manufacturing practice, the manufacturers and the agents of the competent authorities shall refer to the detailed guidelines referred to in Article 19a of Directive 75/319/EEC. These detailed guidelines are published by the Commission in the 'Guide to good manufacturing practice for medicinal products' and in its Annexes (Office for Official Publications of the European Communities, The rules governing medicinal products in the European Community, Volume IV).
Article 4
The manufacturer shall ensure that the manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorization.
For medicinal products imported from third countries, the importer shall ensure that the medicinal products have been manufactured by manufacturers duly authorized and conforming to good manufacturing practice standards, at least equivalent to those laid down by the Community.
Article 5
The manufacturer shall ensure that all manufacturing operations subject to an authorization for marketing are carried out in accordance with the information given in the application for marketing authorization as accepted by the competent authorities.
The manufacturer shall regularly review their manufacturing methods in the light of scientific and technical progress. When a modification to the marketing authorization dossier is necessary, the application for modification must be submitted to the competent authorities. CHAPTER II PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICE
Article 6
Quality management The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different services involved.
Article 7
Personnel 1. At each manufacturing site, the manufacturer shall have competent and appropriately qualified personnel at his disposal in sufficient number to achieve the pharmaceutical quality assurance objective.
2. The duties of managerial and supervisory staff, including the qualified person(s), responsible for implementing and operating good manufacturing practice shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organization chart. Organization charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures.
3. Staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibilities correctly.
4. Personnel shall receive initial and continuing training including the theory and application of the concept of quality assurance and good manufacturing practice.
5. Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes include procedures relating to health, hygiene and clothing of personnel.
Article 8
Premises and equipment 1. Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations.
2. Lay out, design and operation must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product.
3. Premises and equipment intended to be used for manufacturing operations which are critical for the quality of the products shall be subjected to appropriate qualification.
Article 9
Documentation 1. The manufacturer shall have a system of documentation based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations that they perform. Documents shall be clear, free from errors and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be available, together with specific documents for the manufacture of each batch. This set of documents shall make it possible to trace the history of the manufacture of each batch. The batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the certification referred to in Article 22 (2) of Directive 75/319/EEC whichever is the longer.
2. When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall have validated the systems by proving that the data will be appropriately stored during the anticipated period of storage. Data stored by these systems shall be made readily available in legible form. The electronically stored data shall be protected against loss or damage of data (e.g. by duplication or back-up and transfer onto another storage system).
Article 10
Production The different production operations shall be carried out according to pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available for the in-process controls.
Appropriate technical and/or organizational measures shall be taken to avoid cross contamination and mix-ups.
Any new manufacture or important modification of a manufacturing process shall be validated. Critical phases of manufacturing processes shall be regularly revalidated.
Article 11
Quality control 1. The manufacturer shall establish and maintain a quality control department. This department shall be placed under the authority of a person having the required qualifications and shall be independent of the other departments.
2. The quality control department shall have at its disposal one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials, packaging materials and intermediate and finished products testing. Resorting to outside laboratories may be authorized in accordance with Article 12 of this Directive after the authorization referred to in Article 5b of Directive 75/319/EEC has been granted.
3. During the final control of finished products before their release for sale or distribution, in addition to analytical results, the quality control department shall take into account essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the products to their specifications (including the final finished pack).
4. Samples of each batch of finished products shall be retained for at least one year after the expiry date. Unless in the Member States of manufacture a longer period is required, samples of starting materials (other than solvents, gases and water) used shall be retained for at least two years after the release of the product. This period may be shortened if their stability, as mentioned in the relevant specification, is shorter. All these samples shall be maintained at the disposal of the competent authorities.
For certain medicinal products manufactured individually or in small quantities, or when their storage could raise special problems, other sampling and retaining conditions may be defined in agreement with the competent authority.
Article 12
Work contracted out 1. Any manufacturing operation or operation linked with the manufacture which is carried out under contract, shall be the subject of a written contract between the contract giver and the contract acceptor.
2. The contract shall clearly define the responsibilities of each party and in particular the observance of good manufacturing practice by the contract acceptor and the manner in which the qualified person responsible for releasing each batch shall undertake his full responsibilities.
3. The contract acceptor shall not subcontract any of the work entrusted to him by the contract giver without the written authorization of the contract giver.
4. The contract acceptor shall respect the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities as provided for by Article 26 of Directive 75/319/EEC.
Article 13
Complaints and product recall The manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time the medicinal products in the distribution network. Any complaint concerning a defect shall be recorded and investigated by the manufacturer. The competent authority shall be informed by the manufacturer of any defect that could result in a recall or abnormal restriction on the supply. In so far as possible, the countries of destination shall also be indicated. Any recall shall be made in accordance with the requirements referred to in Article 33 of Directive 75/319/EEC.
Article 14
Self-inspection The manufacturer shall conduct repeated self-inspections as part of the quality assurance system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures. Records of such self-inspections and any subsequent corrective action shall be maintained. CHAPTER III FINAL PROVISIONS
Article 15
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 16
This Directive is addressed to the Member States. | [
"UKSI19922845",
"UKSI19922846"
] |
31991L0338 | 1991 | Council Directive 91/338/EEC of 18 June 1991 amending for the 10th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas measures for the progressive establishment of the internal market should be adopted over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
Whereas the Council resolution of 25 January 1988 (4) invites the Commission to pursue without delay the development of specific measures for a Community action programme to combat environmental pollution by cadmium; whereas human health also has to be protected and an overall strategy that in particular restricts the use of cadmium and stimulates research into substitutes should therefore be implemented;
Whereas advances are being made in knowledge and techniques regarding substitutes; whereas it would therefore be advisable systematically to reassess the situation in the light of the results of the scientific and technical studies provided for in the said resolution;
Whereas polyvinyl chloride (PVC) may not be coloured using cadmium-based pigments; whereas, for certain particular applications, the use of a cadmium-based stabilizer is still necessary in the current state of technology;
Whereas restrictions already adopted by certain Member States on the use and marketing of the abovementioned substances or preparations containing them have a direct effect on the establishment and functioning of the internal market; whereas it is therefore necessary to approximate the laws of the Member States in this field and to amend Annex I to Directive 76/769/EEC (5), as last amended by Directive 89/678/EEC (6), accordingly,
Article 1
Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex hereto. However, the new provisions shall not apply to products containing cadmium which are already covered by other Community legislation.
Article 2
Owing to the development of knowledge and techniques in respect of substitutes less dangerous than cadmium and its compounds, the Commission shall, in consultation with the Member States, reassess the situation for the first time within three years of the date referred to in Article 3 (1) and subsequently at regular intervals in accordance with the procedure laid down in Article 2a of Directive 76/769/EEC.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1992. They shall forthwith inform the Commission thereof.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19931643"
] |
31991L0477 | 1991 | COUNCIL DIRECTIVE of 18 June 1991 on control of the acquisition and possession of weapons (91/477/EEC)
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Article 8a of the Treaty provides that the internal market must be established by not later than 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured, in accordance with the provisions of the Treaty;
Whereas, at its meeting in Fontainebleau on 25 and 26 June 1984, the European Council expressly set the objective of abolishing all police and customs formalities at intra-Communiry frontiers;
Whereas the total abolition of controls and formalities at intra-Community frontiers entails the fulfilment of certain fundamental conditions; whereas in its white paper ‘Completing the internal market’ the Commission stated that the abolition of controls on the safety of objects transported and on persons entails, among other things, the approximation of weapons legislation;
Whereas abolition of controls on the possession of weapons at intra-Community frontiers necessitates the adoption of effective rules enabling controls to be carried out within Member States on the acquisition and possession of firearms and on their transfer to another Member State; whereas systematic controls must therefore be abolished at intra-Community frontiers;
Whereas the mutual confidence in the field of the protection of the safety of persons which these rules will generate between Member States will be the greater if they are underpinned by partially harmonized legislation; whereas it would therefore be useful to determine category of firearms whose acquisition and possession by private persons are to be prohibited, or subject to authorization, or subject to declaration;
Whereas passing from one Member State to another while in possession of a weapon should, in principle, be prohibited; whereas a derogation therefrom is acceptable only if a procedure is adopted that enables Member States to be notified that a firearm is to be brought into their territory;
Whereas, however, more flexible rules should be adopted in respect of hunting and target shooting in order to avoid impeding the free movement of persons more that is necessary;
Whereas the Directive does not affect the right of Member States to take measures to prevent illegal trade in weapons,
CHAPTER 1
Scope
Article 1
1. For the purposes of this Directive ‘weapons’ and ‘firearms’ shall have the meanings ascribed to them in Annex I. Firearms are classified and defined in section II of that Annex.
2. For the purposes of this Directive ‘dealer’ shall mean any natural or legal person whose trade or business consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of firearms.
3. For the purposes of this Directive, a person shall be deemed to be a resident of the country indicated by the address appearing on a document establishing his place of residence, such as a passport or an identity card, which, on a check on possession or on acquisition, is submitted to the authorities of a Member State or to a dealer.
4. The ‘European firearms pass’ is a document which is issued on request by the authorities of a Member State to a person lawfully entering into possession of and using a firearm. It shall be valid for a maximum period of five years. The period of validity may be extended. Where only firearms classified in category D appear on the pass, the maximum period of validity thereof shall be ten years. It shall contain the information set out in Annex II. The ‘European firearms pass’ is a non-transferable document, on which shall be entered the firearm or firearms possessed and used by the holder of the pass. The pass must always be in the possession of the person using the firearm. Changes in the possession or characteristics of the firearms shall be indicated on the pass, as well as the loss or theft of the firearm.
Article 2
1. This Directive is without prejudice to the application of national provisions concerning the carrying of weapons, hunting or target shooting.
2. This Directive shall not apply to the acquisition or possession of weapons and ammunition, in accordance with national law, by the armed forces, the police, the public authorities or by collectors and bodies concerned with the cultural and historical aspects of weapons and recognized as such by the Member State in whose territory they are established. Nor shall it apply to commercial transfers of weapons and ammunition of war.
Article 3
Member States may adopt in their legislation provisions which are more stringent than those provided for in this Directive, subject to the rights conferred on residents of the Member States by Article 12 (2).
CHAPTER 2
Harmonization of legislation concerning firearms
Article 4
At least in respect of categories A and B, each Member State shall make the pursuit of the activity of dealer within its territory conditional upon authorization on the basis of at least a check on the private and professional integrity of the dealer. In the case of a legal person, the check shall be on the person who directs the undertaking. In respect of categories C and D, each Member State which does not make the pursuit of the activity of dealer conditional upon authorization shall make such activity subject to a declaration.
Each dealer shall be required to keep a register in which information concerning all firearms classified in category A, B or C received or disposed of by him shall be recorded, including such particulars as enable the weapon to be identified, in particular the type, make, model, calibre and serial number thereof and the names and addresses of the supplier and the person acquiring the weapon. The Member States shall regularly check dealers' compliance with this obligation. The dealer shall conserve the register for a period of five years, even after he has ceased his activity.
Article 5
Without prejudice to Article 3, Member States shall allow the acquisition and possession of firearms classified in category B only by persons who have good cause and who:
(a)
are 18 years old or more, except for hunting or target shooting;
(b)
are not likely to be a danger to themselves, to public order or to public safety.
Without prejudice to Article 3, Member States shall allow the possession of firearms classified in categories C and D only by persons satisfying the conditions in point (a) of the first paragraph.
Member States may withdraw authorization for possession of the firearm if any of the conditions in point (b) of the first paragraph is no longer satisfied.
Member States may not prohibit persons resident within their territories from possessing a weapon acquired in another Member State unless they prohibit the acquisition of the same weapon within their own territories.
Article 6
Member States shall take all appropriate steps to prohibit the acquisition and the possession of the firearms and ammunition classified in category A. In special cases, the competent authorities may grant authorizations for such firearms and ammunition where this is not contrary to public security or public order.
Article 7
1. No one may acquire a firearm classified in category B within the territory of a Member State unless that Member State has so authorized him.
No such authorization may be given to a resident of another Member State without the latter's prior agreement.
2. No one may be in possession of a firearm classified in category B within the territory of a Member State unless that Member State has so authorized him. If he is a resident of another Member State, that other Member State shall be informed accordingly.
3. An authorization to acquire and an authorization to possess a firearm classified in category B may take the form of a single administrative decision.
Article 8
1. No one may be in possession of a firearm classified in category C unless he has declared it to the authorities of the Member State in which that firearm is held.
The Member States shall provide for the compulsory declaration of all firearms classified in category C at present held within their territories but not previously declared within one year of the entry into force of the national provisions transposing this Directive.
2. Every seller, dealer or private person shall inform the authorities of the Member State in which it takes place of every transfer or handing over of a firearm classified in category C, giving the particulars by which the firearm and the person acquiring it may be identified. If the person acquiring such a firearm is a resident of another Member State, that other Member State shall be informed of the acquisition by the Member State in which it took place and by the person acquiring the firearm.
3. If a Member State prohibits or makes subject to authorization the acquisition and possession within its territory of a firearm classified in category B, C or D, it shall so inform the other Member States, which shall expressly include a statement to that effect on any European firearms pass they issue for such a firearm, pursuant to Article 12 (2).
Article 9
1. The handing over of a firearm classified in category A, B or C to a person who is not resident in the Member State in question shall be permitted, subject to compliance with the obligations laid down in Articles 6, 7 and 8:
— where the person acquiring it has been authorized in accordance with Article 11 himself to effect a transfer to his country of residence,
— where the person acquiring it submits a written declaration testifying to and justifying his intention to be in possession of the firearm in the Member State of acquisition, provided that he fulfils the legal conditions for possession in that Member State.
2. Member States may authorize the temporary handing over of firearms in accordance with procedures which they shall lay down.
Article 10
The arrangements for the acquisition and possession of ammunition shall be the same as those for the possession of the firearms for which the ammunition is intended.
CHAPTER 3
Formalities for the movement of weapons within the Community
Article 11
1. Firearms may, without prejudice to Article 12, be transferred from one Member State to another only in accordance with the procedure laid down in the following paragraphs. These provisions shall also apply to transfers of firearms following a mail order sale.
2. Where a firearm is to be transferred to another Member State, the person concerned shall, before it is taken there, supply the following particulars to the Member State in which such firearm is situated:
— the names and addresses of the person selling or disposing of the firearm and of the person purchasing or acquiring it or, where appropriate, of the owner,
— the address to which the firearm is to be consigned or transported,
— the number of firearms to be consigned or transported,
— the particulars enabling the firearm to be identified and also an indication that the firearm has undergone a check in accordance with the Convention of 1 July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms,
— the means of transfer,
— the date of departure and the estimated date of arrival.
The information referred to in the last two indents need not be supplied where the transfer takes place between dealers.
The Member State shall examine the conditions under which the transfer is to be carried out, in particular with regard to security.
Where the Member State authorizes such transfer, it shall issue a licence incorporating all the particulars referred to in the first subparagraph. Such licence shall accompany the firearm until it reaches its destination; it shall be produced whenever so required by the authorities of the Member States.
3. In the case of transfer of the firearms, other than weapons of war, excluded from the scope of this Directive pursuant to Article 2 (2), each Member State may grant dealers the right to effect transfers of firearms from its territory to a dealer established in another Member State without the prior authorization referred to in paragraph 2. To that end it shall issue an authorization valid for no more than three years, which may at any time be suspended or cancelled by reasoned decision. A document referring to that authorization must accompany the firearm until it reaches its destination; it must be produced whenever so required by the authorities of the Member States.
Not later than the time of transfer, the dealer shall communicate to the authorities of the Member State from which the transfer is to be effected all the particulars listed in the first subparagraph of paragraph 2.
4. Each Member State shall supply the other Member States with a list of firearms the transfer of which to its territory may not be authorized without its prior consent.
Such lists of firearms shall be communicated to dealers who have obtained approval for transferring firearms without prior authorization under the procedure laid down in paragraph 3.
Article 12
1. If the procedure provided for in Article 11 is not employed, the possession of a firearm during a journey through two or more Member States shall not be permitted unless the person concerned has obtained the authorization of each of those Member States.
Member States may grant such authorization for one or more journeys for a maximum period of one year, subject to renewal. Such authorizations shall be entered on the European firearms pass, which the traveller must produce whenever so required by the authorities of the Member States.
2. Notwithstanding paragraph 1, hunters, in respect of categories C and D, and marksmen, in respect of category B, C and D, may without prior authorization be in possession of one or more firearms classified in these categories during a journey through two or more Member States with a view to engaging in their activities, provided that they are in possession of a European firearms pass listing such firearm or firearms and provided that they are able to substantiate the reasons for their journey, in particular by producing an invitation.
However, this derogation shall not apply to journeys to a Member State which prohibits the acquisition and possession of the firearm in question or which, pursuant to Article 8 (3), makes it subject to authorization; in that case, an express statement to that effect shall be entered on the European firearms pass.
In the context of the report referred to in Article 17, the Commission in consultation with the Member States, will also consider the effects of applying the second subparagraph, particularly as regards its impact on public order and public security.
3. Under agreements for the mutual recognition of national documents, two or more Member States may provide for arrangements more flexible than those prescribed in this Article for movement with firearms within their territories.
Article 13
1. Each Member State shall communicate all useful information at its disposal concerning definitive transfers of firearms to the Member State to the territory of which such a transfer has been effected.
2. All information that Member States receive by way of the procedures laid down in Article 11 for transfers of firearms and in Article 7 (2) and Article 8 (2) for the acquisition and possession of firearms by non-residents shall be communicated, not later than the time of the relevant transfers, to the Member States of destination and, where appropriate, not later than the time of transfer to the Member States of transit.
3. Member States shall set up, by 1 January 1993 at the latest, networks for the exchange of information for the purposes of applying this Article. They shall inform the other Member States and the Commission of the national authorities responsible for transmitting and receiving information and for applying the formalities referred to in Article 11 (4).
Article 14
Member States shall adopt all relevant provisions prohibiting entry into their territory:
— of a firearm except in the cases defined in Articles 11 and 12 and provided the conditions laid down therein are met,
— of a weapon other than a firearm provided that the national provisions of the Member State in question so permit.
CHAPTER 4
Final provisions
Article 15
1. Member States shall intensify controls on the possession of weapons at external Community frontiers. They shall in particular ensure that travellers from third countries who intend to proceed to another Member State comply with Article 12.
2. This Directive shall not preclude the carrying out of controls by Member States or by the carrier at the time of boarding of a means of transport.
3. Member States shall inform the Commission of the manner in which the controls referred to in paragraphs 1 and 2 are carried out. The Commission shall collate this information and make it available to all Member States.
4. Member States shall notify the Commission of their national provisions, including changes relating to the acquisition and possession of weapons, where the national law is more stringent than the minimum standard they are required to adopt. The Commission shall pass on such information to the other Member States.
Article 16
Member States shall introduce penalties for failure to comply with the provisions adopted pursuant to this Directive. Such penalties must be sufficient to promote compliance with such provisions.
Article 17
Within five years from the date of transposition of this Directive into national law, the Commission shall submit a report to the European Parliament and to the Council on the situation resulting from the application of this Directive, accompanied, if appropriate, by proposals.
Article 18
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive in good time so that the measures provided for by this Directive may be put into effect not later than 1 January 1993. They shall forthwith inform the Commission and the other Member States of the measures taken.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 19
This Directive is addressed to the Member States. | [
"UKSI19922823"
] |
31991L0339 | 1991 | Council Directive 91/339/EEC of 18 June 1991 amending for the 11th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas measures for the progressive establishment of the internal market should be adopted over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
Whereas Directive 76/769/EEC (4), as last amended by Directive 91/338/EEC (5), imposes, in its version as amended by Directive 85/467/EEC (6), severe restrictions on the marketing and use of PCBs and PCTs as a consequence of the risks to man and the environment;
Whereas several substitutes have been developed to replace PCBs; whereas some of these substitutes, though less dangerous to man and the environment than PCBs and PCTs, nevertheless constitute a potentially high risk to man and the environment;
Whereas it is therefore necessary to restrict the marketing and use of these substitutes;
Whereas the substance bearing the trade name Ugilec 141 has been on the market since 1981; whereas this substance or preparations containing this substance are currently used as a dielectric fluid in condensers and transformers and as a hydraulic fluid in coal mines; whereas it is recognized that this substance is less dangerous to man and the environment than the PCBs it was designed to replace;
Whereas by virtue of its ecotoxcity, persistence and potential to bioaccumulate, this substance nevertheless constitutes a high risk to the environment; whereas significant environmental contamination has already been documented in the vicinity of mining operations using this substance as a hydraulic fluid; whereas in the event of a fire involving any equipment containing this substance highly toxic substances may be given off; whereas final disposal of Ugilec 141 requires special procedures;
Whereas the substance bearing the trade name Ugilec 121 or Ugilec 21, being a new substance, was notified on 15 March 1984, in accordance with Council Directive 79/831/EEC of 18 September 1979 amending for the sixth time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (7) and can therefore be marketed throughout the Community; whereas this substance has similar properties and behaviour and was intended for uses similar to that Ugilec 141; whereas the manufacturer has subsequently withdrawn the substance Ugilec 121 or 21 voluntarily from the market; whereas restrictive measures are necessary to ensure that the preparations or products containing the said substance are not re-introduced on the market at a future date;
Whereas the substance bearing the trade name DBBT, being also a new substance, was notified in accordance with Directive 79/831/EEC on 16 February 1988 and can therefore be marketed throughout the Community; whereas the intended use of this substance either on its own or in preparations is as a hydraulic fluid in coal mines; whereas in the meantime a temporary official authorization granted in one Member State has expired; whereas such usage can be expected to result in significant environmental contamination; whereas by virtue of its ecotoxicity, persistence and potential to bioaccumulate this substance constitues a potentially high risk to the environment; whereas restrictive measures should be introduced before this substance has become established on the Community market;
Whereas effective replacements or alternative approaches already exist which make the continued use of these three substances unnecessary;
Whereas restrictions on use or marketing already adopted by certain Member States in respect of the substances referred to above or of preparations or products containing them have a direct effect on the establishment and functioning of the internal maket; whereas it is therefore necessary to approximate the laws of the Member States in this field, and consequently to amend Annex I to Directive 76/769/EEC,
Article 1
The following points are hereby added to Annex I to Directive 76/769/EEC:
'25. Monomethyl - tetrachlorodiphenyl methane
Trade name: Ugilec 141
CAS No 76253-60-6 As from 18 June 1994 the marketing and use of this substance and of preparations and products containing it shall be prohibited. By way of exception this provision shall not apply: 1. in the case of plant and machinery already in service on 18 June 1994 until such plant and machinery is disposed of. However, as from 18 June 1994 Member States may, on grounds of health protection and environmental protection, prohibit within their territory the use of such plant or machinery before it is disposed of; 2. in the case of the maintenance of plant and machinery already in service on 18 June 1994. As from 18 June 1994 the placing on the secondhand market of this substance, preparations containing this substance and plant/machinery containing this substance, shall be prohibited. 26. Monomethyl-dichloro-diphenyl methane -
Trade name: Ugilec 121, Ugilec 21
CAS No - unknown The marketing and use of this substance and of preparations and products containing it shall be prohibited. 27. Monomethyl-dibromo-diphenyl methane -
Trade name: DBBT
CAS No 99688-47-8 The marketing and use of this substance and of preparations and products containing it shall be prohibited.'
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 18 June 1992. They shall forthwith inform the Commission thereof.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19920031"
] |
31991L0371 | 1991 | COUNCIL DIRECTIVE of 20 June 1991 on the implementation of the Agreement between the European Economic Community and the Swiss Confederation concerning direct insurance other than life assurance (91/371/EEC)
Having regard to the Treaty establishing the European Economic Community, and in particular the last sentence of Article 57 (2) and Article 235 thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas an Agreement between the European Economic Community and the Swiss Confederation concerning direct insurance other than life assurance was signed at Luxembourg on 10 October 1989;
Whereas one of the effects of that Agreement is to impose, in relation to insurance undertakings which have their head offices in Switzerland, legal rules different from those applicable, under Title III of Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct insurance other than life assurance (4), to agencies and branches established within the Community of undertakings whose head offices are outside the Community;
Whereas the coordinated rules relating to the pursuit of these activities within the Community by the Swiss undertakings subject to the provisions of the said Agreement must take effect on the same date in all the Member States of the Community; whereas that Agreement will not come into force until the first day of the calendar year following the date on which the instruments of approval are exchanged,
Article 1
The Member States shall amend their national provisions to comply with the Agreement between the European Economic Community and the Swiss Confederation within a period of 24 months following the notification of this Directive. They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 2
The Member States shall specify in their national provisions that the amendments thereto made pursuant to the Agreement shall not come into force until the date on which the Agreement enters into force.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19933127"
] |
31991L0368 | 1991 | Council Directive 91/368/EEC of 20 June 1991 amending Directive 89/392/EEC on the approximation of the laws of the Member States relating to machinery
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission(1) ,
In cooperation with the European Parliament(2) ,
Having regard to the opinion of the Economic and Social Committee(3) ,
Whereas machinery entailing specific risks due either to its mobility or its ability to lift loads, or to both these phenomena together, must satisfy both the general health and safety requirements set out in Directive 89/392/EEC(4) and the health and safety requirements relating to those specific risks;
Whereas it is unnecessary to provide for certification procedures for those types of machinery other than those initially provided for in Directive 89/392/EEC.
Whereas prescribing supplementary essential health and safety requirements for the specific risks due to mobility and the lifting of loads can be effected by amending Directive 89/392/EEC to inlcude these complementary provisions; whereas this amendment can be used to correct certain imperfections in the essential health and safety requirements applying to all machinery;
Whereas it is necessary to provide for transitional arrangements enabling Member States to authorize the placing on the market and putting into service of machinery manufactured in accordance with the national rules in force on 31 December 1992;
Whereas certain equipment or machinery covered by existing Directives comes within the scope of this Directive; whereas it is preferable to have one single Directive to cover all equipment; whereas it is therefore desirable that the relevant existing Directives be repealed on the date this Directive is applied,
Article 1
Directive 89/392/EEC is hereby amended as follows:
1. Article 1 is amended as follows:
(a) in paragraph 2, the following subparagraph shall be added:
' "Machinery" also means interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool';
(b) in paragraph 3:
- the first indent is deleted,
- the second indent is replaced by the following: '- lifting equipment designed and constructed for raising and/or moving persons with or without loads, except for industrial trucks with elevating operator position.',
- in the third indent, the following phrase is added:
'unless it is a machine used for lifting or lowering loads,',
- the following indents are added:
'- means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or on road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, on public road or rail networks or on water. Vehicles used in the mineral extraction industry shall not be excluded,
- seagoing vessels and mobile offshore units together with equipment on board such vessels or units,
- cableways for the public or private transportation of persons,
- agricultural and forestry tractors, as defined in Article 1 (1) of Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors(5) , as lasted amended by Directive 88/297/EEC(6) ,
- machines specially designed and constructed for military or police purposes.
(1) OJ No L 84, 28. 3. 1974, p. 10.
(2) OJ No L 126, 20. 5. 1988, p. 52.'
2. In Article 2 (3), first sentence, the phrase '... provisions of this Directive' is replaced by 'Community provisions in force'.
3. In Article 4 (2), the following subparagraph is added:
' "Interchangeable equipment", within the meaning of the third subparagraph of Article 1 (2), shall be regarded as machinery and accordingly must in all cases bear the EC mark and be accompanied by the EC declaration of conformity referred to in Annex II (A).'
4. In Article 8, the following paragraph is added:
'7. The obligations laid down in paragraph 6 shall not apply to persons who assemble with a machine or tractor interchangeable equipment as provided for in Article 1, provided that the parts are compatible and each of the constituent parts of the assembled machine bears the EC mark and is accompanied by the EC declaration of conformity.'
5. Article 13 is replaced by the following:
'Article 13
1. Before 1 January 1992 Member States shall adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
The Member States shall apply the measures in question with effect from 1 January 1993, except as regards the equipment referred to in Directives 86/295/EEC(7) , 86/296/EEC(8) and 86/663/ EEC(9) , for which these measures shall apply from 1 July 1995.
2. Furthermore, Member States shall allow, for the period until 31 December 1994, except as regards the equipment referred to in Directives 86/295/EEC, 86/296/EEC and 86/663/EEC, for which this period shall end on 31 December 1995, the placing on the market and putting into service of machinery in conformity with the national regulations in force in their territory on 31 December 1992.
Directives 86/295/EEC, 86/296/EEC and 86/663/EEC shall not impede implementation of paragraph 1 as from 1 July 1995.
3. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
4. The Commission shall, before 1 January 1994, examine the progess made in the stadardization work relating to this Directive and propose any appropriate measures.
(1) OJ No L 186, 8. 7. 1986, p. 1.
(2) OJ No L 186, 8. 7. 1986, p. 10.
(3) OJ No L 384, 31. 12. 1986, p. 12.'
6. Annex I is amended as follows:
(a) In section 1.3.7 the following paragraph is added:
'All necessary steps must be taken to prevent accidental blockage of moving parts involved in the work. In cases where, despite the precautions taken, a blockage is likely to occur, specific protection devices or tools, the instruction handbook and possibly a sign on the machinery should be provided by the manufacturer to enable the equipment to be safely unblocked.';
(b) The following section is inserted:
'1.6.5.Cleaning of internal parts
The machinery must be designed and constructed in such a way that it is possible to clean internal parts which have contained dangerous substances or preparations without entering them; any necessary unblocking must also be possible from the outside. If it is absolutely impossible to avoid entering the machinery, the manufacturer must take steps during its construction to allow cleaning to take place with the minimum of danger.';
(c) In section 1.7.0 the following paragraph is added:
'Where the health and safety of exposed persons may be endagered by a fault in the operation of unsupervised machinery, the machinery must be equipped to give an appropriate acoustic or light signal as a warning.';
(d) In section 1.7.3 the following paragraphs are added:
'Where a machine part must be handled during use with lifting equipment, its mass must be indicated legibly, indelibly and unambiguously.
The interchangeable equipment referred to in Article 1 (2), third subparagraph must bear the same information.';
(e) In section 1.7.4 (a) the following indent is added:
'- where necessary, the essential characteristics of tools which may be fitted to the machinery.';
(f) In section 1.7.4 (f) the third paragraph is replaced by the following:
'Where the harmonized standards are not applied, sound levels must be measured using the most appropriate method for the machinery.';
(g) Sections 3 to 5.7 set out in Annex I to this Directive are added.
7. In Annex II (B) the following indents are inserted after the second indent:
'- where appropriate, the name and address of the notified body and the number of the EC type-examination certificate,
- where appropriate, the name and address of the notified body to which the file has been forwarded in accordance with the first indent of Article 8 (2) (c),
- where appropriate, the name and address of the notified body which has carried out the verification referred to in the second indent of Article 8 (2) (c),
- where appropriate, a reference to the harmonized standards.'
8. In Annex IV, item 12 is replaced by items 12 to 15 set out in Annex II to this Directive.
Article 2
The following are hereby repealed as from 31 December 1994:
- Articles 2 and 3 of Council Directive 73/361/EEC of 19 November 1973 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the certification and marking of wire ropes, chains and hooks(10) , as lasted amended by Directive 76/434/EEC(11) ,
- Commission Directive 76/434/EEC of 13 April 1976 adapting to technical progress the Council Directive of 19 November 1973 on the approximation of the laws of the Member States relating to the certification and marking of wire ropes, chains and hooks.
The following are hereby repealed as from 31 December 1995:
- Council Directive 86/295/EEC of 26 May 1986 on the approximation of the laws of the Member States relating to roll-over protective structures (ROPS) for certain construction plant(12) ,
- Council Directive 86/296/EEC of 26 May 1986 on the approximation of the laws of the Member States relating to falling-object protective structures (FOPS) for certain construction plant(13) ,
- Council Directive 86/663/EEC of 22 December 1986 on the approximation of the laws of the Member States relating to self-propelled industrial trucks(14) , as last amended by Directive 89/240/EEC(15) .
Article 3
1. Before 1 January 1992 Member States shall adopt and publish the laws, regulations and administrative provisions necessary in order to comply with this Directive. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
They shall apply these measures with effect from 1 January 1993.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19923073"
] |
31991L0382 | 1991 | Council Directive 91/382/EEC of 25 June 1991 amending Directive 83/477/EEC on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC)
Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof,
Having regard to the proposal from the Commission drawn up following consultation with the Advisory Committee on Safety, Hygiene and Health Protection at Work(1),
In cooperation with the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas Article 118a of the Treaty provides that the Council shall adopt, by means of directives, minimum requirements for encouraging improvements, especially in the working environment, to ensure a better level of protection of the safety and health of workers;
Whereas, under the terms of that Article, such directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-size undertakings.
Whereas the communication from the Commission on its programme concerning safety, hygiene and health at work(4) provides for the adoption of directives designed to guarantee the safety and health of workers;
Whereas the Council, in its resolution of 21 December 1987 on safety, hygiene and health at work(5), took note of the Commission's intention of submitting to the Council in the near future minimum requirements at Community level concerning protection against the risks resulting from dangerous substances, including carcinogenic substances; whereas it considered that in this connection the principle of substitution using a recognized non-dangerous or less dangerous substance should be taken as a basis;
Whereas asbestos is a particularly hazardous agent which can cause serious illness and which is found in various forms in a large number of circumstances at work;
Whereas, in view of the progress made in scientific knowledge and technology and in the light of experience gained in applying Council Directive 83/447/EEC of
19 September 1983 on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC)(6), the protection of workers
should be improved and the action levels and limit values laid down in Directive 83/477/EEC should be reduced;
Whereas the prohibition of the application of asbestos by means of the spraying process is not sufficient to prevent asbestos fibres being released into the atmosphere; whereas other working procedures that involve the use of certain materials containing asbestos must also be prohibited;
Whereas a decision cannot yet be taken establishing a single method for measurement of asbestos-in-air concentrations at Community level;
Whereas this Directive should be reviewed by 31 December 1995, taking account, in particular, of progress made in scientific knowledge and technology and of experience gained in applying this Directive;
Whereas Decision 74/325/EEC(7), as last amended by the 1985 Act of Accession, provides that the Advisory Committee on Safety, Hygiene and Health Protection at Work is to be consulted by the Commission for the purpose of drafting proposals in this field,
Article 1
Directive 83/477/EEC is hereby amended as follows:
1.Article 3 (3) shall be replaced by the following:
'3. If the assessment referred to in paragraph 2 shows that the concentration of asbestos fibres in the air at the place of work in the absence of any personal protective equipment is, at the option of the Member States, at a level as measured or calculated:
(a)for chrysotile
-lower than 0,20 fibres per cm3 in relation to an eight-hour reference period, and/or
-lower than a cumulative dose of 12,00 fibre-days per cm3 over a three-month period;
(b)for all other forms of asbestos either alone or in mixtures, including mixtures containing chrysotile: -lower than 0,10 fibres per cm3 in relation to an eight-hour reference period, and/or
-lower than a cumulative dose of 6,00 fibre-days per cm3 over a three-month period,
Articles 4, 7, 13, 14 (2), 15 and 16 shall not apply.'
2.Article 5 shall be replaced by the following:
'Article 5
The application of asbestos by means of the spraying process and working procedures that involve using low-density (less than 1g/cm3) insulating or soundproofing materials which contain asbestos shall be prohibited.'
3.In point (1) of Article 7, the third paragraph shall be replaced by the following:
'In accordance with Article 118a of the Treaty and taking account in particular of progress made in scientific knowledge and technology and of experience gained in applying this Directive, the Council shall review the provisions of the first sentence of the first paragraph by 31 December 1995, with a view to establishing a single method for measurement of asbestos-in-air concentrations as Community level;'.
4.Article 8 shall be replaced by the following:
'Article 8
The following limit values shall be applied:
(a)concentration of chrysotile fibres in the air at the place of work:
0,60 fibres per cm3 measured or calculated in relation to an eight-hour reference period;
(b)concentration in the air at the place of work of all other forms of asbestos fibres, either alone or in mixtures, including mixtures containing chrysotile:
0,30 fibres per cm3 measured or calculated in relation to an eight-hour reference period.'
5.Article 9 shall be replaced by the following:
'Article 9
1. Without prejudice to the third paragraph of point 1 of Article 7, in accordance with Article 118a of the Treaty and taking account in particular of progress made in scientific knowledge and technology and of experience gained in applying this Directive, the Council shall review the provisions of this Directive by 31 December 1995.
2. The amendments required to adapt the Annexes to this Directive to take account of technical progress shall be made in accordance with the procedure described in Articles 9 and 10 of Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (*).
(*)OJ No L 327, 3.12.1980, p. 8.'
6.Article 12 is hereby amended as follows:
(a)the following subparagraph shall be added to paragraph 2:
'At the request of the competent authorities, the plan shall include information on the following:
-the nature and probable duration of the work,
-the place where the work is carried out,
-the methods applied where the work involves the handling of asbestos or of materials containing asbestos,
-the characteristics of the equipment used for:
-protection and decontamination of those carrying out the work,
-protection of other persons present on or near the worksite.'.
(b)the following paragraph shall be added:
'3.At the request of the competent authorities, the plan referred to in paragraph 1 must be notified to them before the start of the projected work.'.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1993.
They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
The date 1 January 1993 shall, however, be replaced by
1 January 1996 in the case of asbestos-mining activities.
However, as regards the Hellenic Republic:
-the date referred to in the first subparagraph shall be
1 January 1996,
-the date referred to in the fourth subparagraph shall be 1 January 1999.
2.Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19923068"
] |
31991L0383 | 1991 | COUNCIL DIRECTIVE of 25 June 1991 supplementing the measures to encourage improvements in the safety and health at work of workers with a fixed-duration employment relationship or a temporary employment relationship (91/383/EEC)
Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Article 118a of the Treaty provides that the Council shall adopt, by means of Directives, minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the safety and health of workers;
Whereas, pursuant to the said Article, Directives must avoid imposing administrative, financial and legal constraints which would hold back the creation and development of small and medium-sized undertakings;
Whereas recourse to forms of employment such as fixed-duration employment and temporary employment has increased considerably;
Whereas research has shown that in general workers with a fixed-duration employment relationship or temporary employment relationship are, in certain sectors, more exposed to the risk of accidents at work and occupational diseases than other workers;
Whereas these additional risks in certain sectors are in part linked to certain particular modes of integrating new workers into the undertaking; whereas these risks can be reduced through adequate provision of information and training from the beginning of employment;
Whereas the Directives on health and safety at work, notably Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (4), contain provisions intended to improve the safety and health of workers in general;
Whereas the specific situation of workers with a fixed-duration employment relationship or a temporary employment relationship and the special nature of the risks they face in certain sectors calls for special additional rules, particularly as regards the provision of information, the training and the medical surveillance of the workers concerned;
Whereas this Directive constitutes a practical step within the framework of the attainment of the social dimension of the internal market,
SECTION I
SCOPE AND OBJECT
Article 1
Scope
This Directive shall apply to:
1.
employment relationships governed by a fixed-duration contract of employment concluded directly between the employer and the worker, where the end of the contract is established by objective conditions such as: reaching a specific date, completing a specific task or the occurence of a specific event;
2.
temporary employment relationships between a temporary employment business which is the employer and the worker, where the latter is assigned to work for and under the control of an undertaking and /or establishment making use of his services.
Article 2
Object
1. The purpose of this Directive is to ensure that workers with an employment relationship as referred to in Article 1 are afforded, as regards safety and health at work, the same level of protection as that of other workers in the user undertaking and/or establishment.
2. The existence of an employment relationship as referred to in Article 1 shall not justify different treatment with respect to working conditions inasmuch as the protection of safety and health at work are involved, especially as regards access to personal protective equipment.
3. Directive 89/391/EEC and the individual Directives within the meaning of Article 16 (1) thereof shall apply in full to workers with an employment relationship as referred to in Article 1, without prejudice to more binding and/or more specific provisions set out in this Directive.
SECTION II
GENERAL PROVISIONS
Article 3
Provision of information to workers
Without prejudice to Article 10 of Directive 89/391/EEC, Member States shall take the necessary steps to ensure that:
1.
before a worker with an employment relationship as referred to in Article 1 takes up any activity, he is informed by the undertaking and/or establishment making use of his services of the risks which he faces;
2.
such information:
— covers, in particular, any special occupational qualifications or skills or special medical surveillance required, as defined in national legislation, and
— states clearly any increased specific risks, as defined in national legislation, that the job may entail.
Article 4
Workers' training
Without prejudice to Article 12 of Directive 89/391/EEC, Member States shall take the necessary measures to ensure that, in the cases referred to in Article 3, each worker receives sufficient training appropriate to the particular characteristics of the job, account being taken of his qualifications and experience.
Article 5
Use of workers' services and medical surveillance of workers
1. Member States shall have the option of prohibiting workers with an employment relationship as referred to in Article 1 from being used for certain work as defined in national legislation, which would be particularly dangerous to their safety or health, and in particular for certain work which requires special medical surveillance, as defined in national legislation.
2. Where Member States do not avail themselves of the option referred to in paragraph 1, they shall, without prejudice to Article 14 of Directive 89/391/EEC, take the necessary measures to ensure that workers with an employment relationship as referred to in Article 1 who are used for work which requires special medical surveillance, as defined in national legislation, are provided with appropriate special medical surveillance.
3. It shall be open to Member States to provide that the appropriate special medical surveillance referred to in paragraph 2 shall extend beyond the end of the employment relationship of the worker concerned.
Article 6
Protection and prevention services
Member States shall take the necessary measures to ensure that workers, services or persons designated, in accordance with Article 7 of Directive 89/391/EEC, to carry out activities related to protection from and prevention of occupational risks are informed of the assignment of workers with an employment relationship as referred to in Article 1, to the extent necessary for the workers, services or persons designated to be able to carry out adequately their protection and prevention activities for all the workers in the undertaking and/or establishment.
SECTION III
SPECIAL PROVISIONS
Article 7
Temporary employment relationships: information
Without prejudice to Article 3, Member States shall take the necessary steps to ensure that:
1.
before workers with an employment relationship as, referred to in Article 1 (2) are supplied, a user undertaking and/or establishment shall specify to the temporary employment business, inter alia, the occupational qualifications required and the specific features of the job to be filled;
2.
the temporary employment business shall bring all these facts to the attention of the workers concerned.
Member States may provide that the details to be given by the user undertaking and/or establishment to the temporary employment business in accordance with point 1 of the first subparagraph shall appear in a contract of assignment.
Article 8
Temporary employment relationships: responsibility
Member States shall take the necessary steps to ensure that:
1.
without prejudice to the responsibility of the temporary employment business as laid down in national legislation, the user undertaking and/or establishment is/are responsible, for the duration of the assignment, for the conditions governing performance of the work;
2.
for the application of point 1, the conditions governing the performance of the work shall be limited to those connected with safety, hygiene and health at work.
SECTION IV
MISCELLANEOUS PROVISIONS
Article 9
More favourable provisions
This Directive shall be without prejudice to existing or future national or Community provisions which are more favourable to the safety and health protection of workers with an employment relationship as referred to in Article 1.
Article 10
Final provisions
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1992 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, the latter shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall forward to the Commission the texts of the provisions of national law which they have already adopted or adopt in the field covered by this Directive.
3. Member States shall report to the Commission every five years on the practical implementation of this Directive, setting out the points of view of workers and employers.
The Commission shall bring the report to the attention of the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work.
4. The Commission shall submit to the European Parliament, the Council and the Economic and Social Committee a regular report on the implementation of this Directive, due account being taken of paragraphs 1, 2 and 3.
Article 11
This Directive is addressed to the Member States. | [
"UKSI19922966",
"UKSI19922051",
"UKSI19923004",
"UKSI19922793",
"UKSI19922932"
] |
31991L0441 | 1991 | Council Directive 91/441/EEC of 26 June 1991 amending Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992 ; whereas the internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
Whereas the first programme of action of the European Communities on the protection of the environment, approved by the Council on 22 November 1973, called for account to be taken of the latest scientific advances in combating atmospheric pollution caused by gases emitted from motor vehicles and for Directives adopted previously to be amended accordingly;
Whereas the third programme of action provides for additional efforts to be made to reduce considerably the present level of emissions of pollutants from motor vehicles;
Whereas Directive 70/220/EEC (4), as last amended by Directive 89/491/EEC (5), lays down the limit values for carbon monoxide and unburnt hydrocarbon emissions from the engines of such vehicles ; whereas these limit values were first reduced by Directive 74/290/EEC (6) and supplemented, in accordance with Directive 77/102/EEC (7), by limit values for permissible emissions of nitrogen oxides ; whereas the limit values for these three pollutions were successively reduced by Directives 78/665/EEC (8), 83/351/EEC (9) and 88/76/EEC (10), limit values for particulate pollutant emissions from diesel engines were introduced by Directive 88/436/EEC (11) and more stringent European standards for cars below 1 400 cm3 by Directive 89/458/EEC (12);
Whereas the work undertaken by the Commission in that sphere has shown that the Community has available, or is currently perfecting, technologies which allow a drastic reduction of the limit values in question for all engine sizes;
Whereas, since more stringent emission standards have been laid down by Directive 89/458/EEC for cars below 1 400 cm3, it is now necessary, in accordance with Article 5 of this Directive, to align the limit values for the emissions of cars with an engine capacity equal to or more than 1 400 cm3 to these standards at the same application dates and on the basis of an improved European test procedure including an extra-urban driving sequence;
Whereas it appears appropriate at the same time to lay down requirements relating to the evaporative (1) OJ No C 81, 30.3.1990, p. 1 and OJ No C 281, 9.11.1990, p. 9. (2) OJ No C 260, 15.10.1990, p. 93 and OJ No C 183, 15.7.1991. (3) OJ No C 225, 19.9.1990, p. 7. (4) OJ No L 76, 6.4.1970, p. 1. (5) OJ No L 238, 15.8.1989, p. 43. (6) OJ No L 159, 15.6.1974, p. 61. (7) OJ No L 32, 3.2.1977, p. 32. (8) OJ No L 223, 14.8.1978, p. 48. (9) OJ No L 197, 20.7.1983, p. 1. (10) OJ No L 36, 9.2.1988, p. 1. (11) OJ No L 214, 6.8.1988, p. 1. (12) OJ No L 226, 3.8.1989, p. 1. emissions and to the durability of emission-related vehicle components and to introduce, in accordance with Article 4 of Directive 88/436/EEC, the second stage of the standards for particulate pollutant emissions for cars equipped with diesel engines, thus consolidating the requirements of the European Community relating to the emissions of air pollutants from passenger cars ; whereas the durability test should be based on 80 000 kilometres driven and should be carried out using a procedure involving vehicles which are actually driven on a test track or chassis dynamometer;
Whereas in order to allow the European environment to benefit to the maximum from these provisions and at the same time ensure the unity of the market, it appears necessary to implement the more stringent European standards based on total harmonization;
Whereas the new standards and the test procedure should be laid down in the light of future developments in traffic in the European Community ; whereas completion of the internal market is likely to lead to an increase in vehicle registrations, which will result in an increase in pollutant emissions;
Whereas in view of the major role played by pollutant emissions from motor vehicles and their contribution to the gases responsible for the greenhouse effect, their emissions of CO2 in particular must be stabilized and subsequently reduced in line with the decision of the Governing Council of the United Nations Environment Programme (UNEP) of 24 May 1989, and in particular point 11 (d) thereof;
Whereas the Commission shall submit a proposal for a Directive on the measures to reduce evaporation losses at every stage in the process of storage and distribution of motor fuels;
Whereas there is also an urgent need to improve significantly the quality of fuel at filling stations;
Whereas the introduction of tougher standards would also be speeded up if the Member States introduced a system to encourage purchasers of new vehicles to have their old vehicles scrapped or, as fas as possible, recycled;
Whereas it is desirable that the Member States take measures to ensure that, as far as possible, older vehicles are fitted with exhaust gas cleaning devices;
Whereas the environmental impact of the more stringent standards would be greatly increased and speeded up if the Member States were to grant, after 31 December 1992, tax incentives for the purchase and installation on vehicles already in service of equipment which will ensure that the standards set out in this Directive are complied with;
Whereas the constant increase in environmental pollution caused by the rapid increase in traffic in the Community necessitates not only the adoption of limit values and tougher standards but also the development of alternative propulsion systems and transport concepts ; whereas the Community should take steps to provide financial support for research and development for alternative transport concepts, propulsion systems and fuels taking into account the requirements of environmental compatibility;
Whereas, therefore, in order to maximize the impact of the standards set out in this Directive, the Council, acting by a qualified majority on a proposal from the Commission, shall decide before 31 December 1992 on measures designed to: - limit CO2 emissions,
- adapt the emission standards (and the related tests) for vehicles not covered by this Directive, including all commercial vehicles,
- lay down regular inspections and procedures for replacing, repairing or maintaining the equipment fitted in order to meet the values laid down,
- implement a research and development programme to encourage the marketing of clean vehicles and fuels.
Article 1
The Annexes to Directive 70/220/EEC are replaced by the Annexes to this Directive.
Article 2
1. From 1 January 1992 no Member State may, on grounds relating to air pollution by their emissions: - refuse to grant EEC type-approval, to issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC (1), as last amended by Directive 87/403/EEC (2), or to grant national type-approval for a type of motor vehicle,
or
- prohibit the initial entry into service of motor vehicles, (1) OJ No L 42, 23.2.1970, p. 1. (2) OJ No L 220, 8.8.1987, p. 44. if emissions from that type of motor vehicle or from such vehicles meet the provisions of Directive 70/220/EEC, as amended by this Directive.
2. From 1 July 1992, Member States: - may no longer grant EEC type-approval or issue the document provided for in the last indent of Article 10 (1) of Directive 70/156/EEC for a type of motor vehicle;
- shall refuse national type-approval for a type of motor vehicle,
the emissions from which do not meet the requirements of the Annexes to Directive 70/220/EEC, as amended by this Directive.
3. From 31 December 1992, Member States shall prohibit the initial entry into service of vehicles the emissions from which do not meet the requirements of the Annexes to Directive 70/220/EEC, as amended by this Directive.
Article 3
Member States may make provision for tax incentives for the vehicles covered by this Directive. Such incentives shall meet the provisions of the Treaty as well as the following conditions: - they shall apply to all domestic car production and to vehicles imported for marketing in a Member State and fitted with equipment allowing the European standards to be met in 1992 to be satisfied ahead of time,
- they shall cease upon the dates set in Article 2 (3) for the compulsory entry into force of the emission values for new vehicles,
- they shall be of a value, for each type of vehicle, substantially lower than the actual cost of the equipment fitted to meet the values set and of its fitting on the vehicle.
The Commission shall be informed of any plans to introduce or amend the tax incentives referred to in the first subparagraph in sufficient time to allow it to submit comments.
Article 4
The Council, acting under the conditions laid down in the Treaty, shall decide before 31 December 1993 on a proposal which the Commission, taking into account technical progress, will sumit before 31 December 1992 on a further reduction in limit values.
The reduced limit values shall not apply before 1 January 1996 for new type-approvals ; they may serve as a basis for tax incentives as from the adoption of the new Directive.
Article 5
Acting by a qualified majority on a proposal from the Commission, which will take account of the results of the work in progress on the greenhouse effect, the Council shall decide on measures designed to limit CO2 emissions from motor vehicles.
Article 6
The Commission shall confirm in an additional technical report at the beginning of 1991 the validity of the alternative European durability test (1), which shall be at least as stringent as the durability test defined in Annex VII and shall be more representative of driving conditions in Europe. Where necessary, the accelerated ageing test (1) may be amended on a proposal from the Commission, in accordance with the procedure of the Committee on Adaptation to Technical Progress, by the end of 1991.
Article 7
1. Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive by 1 January 1992. They shall forthwith inform the Commission thereof.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 8
This Directive is addressed to the Member States. | [
"UKSI19912830",
"UKSI19912681",
"UKSI19922137"
] |
31991L0494 | 1991 | Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas poultrymeat is included in the list of products in Annex II to the Treaty; whereas the breeding and rearing of poultry is included in the farming sector and constitutes a source of income for part of the farming population;
Whereas disparities between Member States should be removed by laying down rules regarding the animal health aspects of intra-Community trade in fresh poultrymeat in order to ensure the rational development of that sector and improve productivity by encouraging intra-Community trade, with a view to the completion of the internal market;
Whereas, in particular, to improve information concerning the state of health of the poultry from which fresh meat for consignment to another Member State comes, it should be stipulated that the poultry must either have been reared on the territory of the Community or have been imported from third countries in accordance with Chapter III of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade and imports from third countries of poultry and hatching eggs (4);
Whereas, in order to prevent it from propagating epizootic diseases, fresh meat coming from a holding or area which, in accordance with Community rules, has been placed under health restrictions or from an area infected by avian influenza or Newcastle disease should be excluded from intraCommunity trade;
Whereas care should be taken that fresh poultrymeat that does not comply with Community rules should not be given
the health mark provided for in Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (5), as last amended by Directive 90/484/EEC (6); whereas, such meat may, however, be put to other uses provided that it has undergone treatment designed to destroy the germs of diseases, in which case it will bear a special mark to that effect;
Whereas, in respect of the organization of and the follow-up to the checks being carried out by the Member State of destination and the safeguard measures to be implemented, reference should be made to the general rules laid down in Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (7);
Whereas provision should be made so that inspections may be carried out by the Commission;
Whereas, in the interests of the harmonious development of intra-Community trade; Community arrangements should be defined in respect of imports from third countries;
Whereas defining the said arrangements requires in particular that a list be drawn up of third countries or parts of third countries from which fresh poultrymeat may be imported and that a certificate be produced;
Whereas the Commission's veterinary experts should be instructed to carry out checks in third countries in order to determine whether the Community rules are complied with;
Whereas the rules and general principles governing checks on fresh poultrymeat will be determined later as part of the measures to be taken to bring about the internal market;
Whereas Directive 90/539/EEC should be amended in order to take into account the contents of this Directive, with a view in particular to ensure parallelism with regard to the date on which Member States must comply with the new health rules;
Whereas the provisions of this Directive will have to be reviewed in the context of the completion of the internal market;
Whereas provision should be made for a procedure establishing close cooperation between the Commission and the Member States within the Standing Veterinary Committee;
Whereas it is advisable to allow time to introduce harmonized rules concerning Newcastle disease,
CHAPTER I General provisions
Article 1
This Directive lays down animal health requirements governing intra-Community trade in and imports from third countries of fresh poultrymeat.
Article 2
For the purposes of this Directive, the definitions, and especially those for poultry, set out in Article 2 of Directive 90/539/EEC shall also apply.
Moreover:
(a) 'meat' means any parts of poultry which are fit for human consumption;
(b) 'fresh meat' means any meat, including meat vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any treatment other than cold treatment to ensure its preservation.
CHAPTER II Rules governing intra-community trade
Article 3
A. In order to be traded within the Community fresh meat must have been obtained from poultry which:
1. has been held in Community territory since hatching or has been imported from third countries in accordance with the requirements of Chapter III of Directive 90/539/EEC.
Until 31 December 1992 poultrymeat intended for Member States or regions of Member States the status of which has been recognized in accordance with Article 12 (2) of that Directive must come from poultry which has not been vaccinated against Newcastle disease using an attenuated live vaccine during the 30 days preceding slaughter.
Acting before 1 January 1992 by a qualified majority on a proposal from the Commission based on a report on the risks of transmission of Newcastle disease, the Council shall adopt the rules applicable as from 1 January 1993;
2. comes from a holding:
- which has not been placed under animal health restrictions in connection with a poultry disease,
- which is not situated in an area which has been declared an avian influenza or Newcastle disease infection area;
3. during transport to the slaughterhouse did not come into contact with poultry suffering from avian influenza or Newcastle disease; such transport through an area which has been declared an avian influenza or Newcastle disease infection area shall be prohibited unless major road or rail links are used;
4. comes from slaughterhouses in which, at the time of slaughter, no case of avian influenza or Newcastle disease had been recorded.
Any fresh meat which is suspected of having been contaminated at the slaughterhouse, cutting plant or storage depot or in the course of transport must be excluded from trade;
5. is marked in accordance with Articles 4 and 5;
6. is accompanied by the health certificate provided for in Annex IV to Directive 71/118/EEC, amended in accordance with the Annex to this Directive.
B.
Exempted from this chapter are national controls governing meat:
- contained in the personal luggage of travellers and intended for their personal consumption,
- in small consignments to private individuals, provided that the said consignments are not of a commercial nature,
- for consumption by the crew and passengers on board means of transport operating internationally.
Article 4
Fresh poultrymeat covered by this Directive shall be given the health mark specified in Article 3 (1) A (e) of Directive 71/118/EEC, provided that it meets the requirements laid down in Article 3 (A) of this Directive and that it comes from poultry slaughtered in accordance with the hygiene requirements laid down in Directive 71/118/EEC.
Article 5
1. Notwithstanding Article 4, and insofar as it is not intended for intra-Community trade in fresh meat, fresh poultrymeat which does not satisfy the requirements laid down in Article 3 (A) (2) (3) and the first subparagraph
of (4) may carry a mark in accordance with Article 3 (1) A (e) of Directive 71/118/EEC, provided that this mark is immediately:
(a) either overstamped in such a way that the health mark defined in point 44.1 (a) and (b) of Chapter X of
Annex I to Directive 71/118/EEC is covered by a diagonal cross consisting of two straight lines crossing at right angles, with the point of intersection in the centre of the stamp and the information thereon remaining legible;
(b) or replaced by a single special mark consisting of the health mark defined in point 44 (a) and (b) of Chapter X of Annex I to Directive 71/118/EEC, overstamped in accordance with point (a) of this paragraph.
The provisions of point 43 of Chapter X of Annex I to Directive 71/118/EEC shall apply mutatis mutandis to the keeping and use of marking instruments.
2. The meat referred to in paragraph 1 must be obtained, cut, transported and stored separately from, or not at the same time as, meat intended for intra-Community trade in fresh meat and must be used in such a way as to avoid it being introduced into meat products intended for intraCommunity trade unless they have undergone the treatment specified in Article 4 (1) of Directive 80/215/EEC (8) as last amended by Directive 89/662/EEC.
Article 6
The rules laid down in Directive 89/662/EEC shall apply, in particular as regards the organization of and the follow-up to the checks carried out by the Member State of destination and the safeguard measures to be applied.
Article 7
Commission veterinary experts may, to the extent necessary to ensure uniform application of this Directive, and in conjunction with the competent national authorities, carry out on-the spot inspections. The Commission shall inform the Member States of the outcome of such inspections.
Member States in whose territory an inspection is carried out shall give the experts all the assistance necessary for the performance of their tasks.
General rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 18. The rules to be followed for the inspections provided for in this Article shall be adopted in accordance with the same procedure.
CHAPTER III Rules applicable to imports from third countries
Article 8
1. Fresh poultrymeat imported into the Community must satisfy the requirements laid down in Articles 9 to 12.
2. However, this Chapter shall not apply to:
(a) poultrymeat forming part of travellers' personal luggage and intended for their personal consumption, provided that the quantity transported does not exceed one kilogram per person and that it comes from a third country or part thereof appearing on the list drawn up in accordance with Article 9 and from which importation is not prohibited under Article 14;
(b)
poultrymeat sent as small consignments to private individuals, provided that such meat is not imported by way of trade, that the quantity does not exceed one kilogram and that it comes from a third country or part thereof appearing on the list drawn up in accordance with Article 9 and from which importation is not prohibited under Article 14;
(c)
meat for consumption by the crew and passengers on board means of transport operating internationally.
Where such meat or the resulting kitchen waste is unloaded, it must be destroyed. It is not, however, necessary to destroy meat when it is transferred, directly or after being placed provisionally under customs supervision, from one means of transport to another.
Article 9
1. Fresh poultrymeat must come from a third country or part of a third country appearing on a list drawn up by the Commission in accordance with the procedure laid down in Article 18. The list may be supplemented or amended in accordance with the procedure laid down in Article 17.
2. In deciding whether a third country or part thereof may be included in the list referred to in paragraph 1, particular account shall be taken of:
(a) the state of health of the poultry, other domestic animals and wildlife in the third country, particular attention being paid to exotic animal diseases, and the environmental health situation in that country, where either are liable to endanger public and animal health in the Member States;
(b)
the regularity and rapidity of the supply of information by the third country relating to the existence of contagious animal diseases in its territory, in particular the diseases appearing on lists A and B of the International Office of Epizootics;
(c)
that country's rules on animal disease prevention and control;
(d)
the structure of the veterinary services in the country and their powers;
(e)
the organization and implementation of measures to prevent and control contagious animal diseases;
(f)
that country's legislation on the use of banned substances, in particular legislation concerning the prohibition or authorization of substances, their distribution, placing on the market and the rules on administering and controlling them;
(g)
the guarantees which the third country can give with regard to rules laid down by this Directive.
3. The list referred to in paragraph 1 and any amendments thereto shall be published in the Official Journal of the European Communities.
Article 10
1. Fresh poultrymeat must come from third countries free from avian influenza and Newcastle disease.
2. The general criteria for classifying third countries in terms of the diseases referred to in paragraph 1 shall be adopted in accordance with the procedure laid down in Article 17. These criteria must in no case be more favourable than those adopted for the Member States pursuant to Directive 90/539/EEC.
3. The Commission may, in accordance with the procedure laid down in Article 18, decide that paragraph 1 shall apply only to a part of the territory of a third country.
Article 11
1. Fresh poultrymeat must:
(a) satisfy animal health requirements adopted in accordance with the procedure laid down in Article 17. These requirements may differ according to the species of bird;
(b)
come from flocks which, prior to consignment, have, without interruption, been held in the third country or part thereof for a period to be defined in accordance with the procedure laid down in Article 17.
2. The animal health conditions shall be determined on the basis of the rules laid down in Chapter II and the corresponding Annexes to Directive 90/539/EEC. In accordance with the procedure laid down in Article 18, derogations may be granted on a case-by-case basis, if the third country concerned offers similar animal health guarantees which are at least of an equivalent standard.
Article 12
1. Fresh poultrymeat must be accompanied by a certificate drawn up by an official veterinarian of the exporting third country.
The certificate must:
(a) be issued on the day of loading for consignment to the country of destination;
(b)
be drawn up in the official language or languages of the country of shipment, of the country of destination, and in one of the official languages of the country in which the import checks are to be carried out;
(c)
accompany the consignment in the original;
(d)
attest that the fresh meat satisfies the requirements of this Directive and those adopted pursuant to this Directive with regard to importation from third countries;
(e)
consist of a single sheet of paper;
(f)
be made out for a single consignee.
2. The certificate must conform with a model established in accordance with the procedure laid down in Article 18.
Article 13
On-the-spot inspections shall be carried out by veterinary experts of the Member States and the Commission to ensure that all the provisions of this Directive are effectively applied.
Member States' experts responsible for these inspections shall be designated by the Commission on proposals from the Member States.
The inspections shall be carried out on behalf of the Community, which shall bear the expenditure incurred.
The frequency of the inspections and the inspection procedure shall be determined in accordance with the procedure laid down in Article 18.
Article 14
1. The Commission may, in accordance with the procedure laid down in Article 17, decide that imports from a third country or part thereof are to be confined to fresh poultrymeat of particular species.
2. The Commission may decide, in accordance with the procedure laid down in Article 17, to apply animal health restrictions, as required, after importation.
Article 15
The rules and general principles applicable during inspections in third countries or during inspections of
imported poultrymeat from third countries and the safeguard measures to be implemented shall be those set out in Directive 90/675/EEC (9).
Article 16
1. Pending the implementation of Community health rules concerning imports of poultrymeat from third countries, Member States shall apply to such imports provisions which shall not be more favourable than
those governing intra-Community trade in accordance
with Directive 71/118/EEC and shall make trade in
poultrymeat subject to the requirements laid down in the second subparagraph of Article 6 (1) (b) of Directive 89/662/EEC.
2. To ensure uniform application of these provisions, inspections may be carried out on-the-spot in third countries by veterinary experts of the Member States and the Commission.
Member States' experts responsible for these inspections shall be designated by the Commission on a proposal from the Member States.
The inspections shall be carried out on behalf of the Community, which shall bear the expenditure incurred.
However, Member States shall be entitled to continue to make inspections under national arrangements of any third country establishments which have not been inspected under the Community procedure.
A list of establishments meeting the conditions referred to Annex 1 to Directive 71/118/EEC shall be drawn up in accordance with the procedure laid down in Article 18.
3. The health certificate which accompanies products on import, and the form and nature of the health mark which the products shall bear, shall correspond to a model to be determined in accordance with the procedure laid down in Article 18.
CHAPTER IV Common provisions
Article 17
Where the procedure laid down in this Article is to be used, the Standing Veterinary Committee (hereinafter referred to as 'the Committee'), set up by Decision 68/361/EEC ($), shall discuss the matter in accordance with the rules laid down in Article 12 of Directive 71/118/EEC.
Article 18
Where the procedure laid down in this Article is to be
used, the Committee shall discuss the matter in accordance
with the rules laid down in Article 12 a of Directive 71/118/EEC.
Article 19
1. Annex A to Directive 89/662/EEC shall be supplemented by the following text:
'- Council Directive 91/494/EEC of 26 June 1991, on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat (OJ No L 268, 24. 9. 1991, p. 35).'
2. Directive 90/539/EEC shall be amended as follows:
(a) In Article 12 (2), first subparagraph, the phrase 'at the latest six months before the date on which the Member States must conform to this Directive' shall be deleted.
(b)
In Article 36, the date '1 January 1992' shall be replaced by '1 May 1992'.
Article 20
In connection with the proposals for completing the internal market the Council shall review the provisions of this Directive before 31 December 1992, acting by a qualified majority on a proposal from the Commission.
Article 21
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 May 1992. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 22
This Directive is addressed to the Member States. | [
"UKSI19800014"
] |
31991L0422 | 1991 | Commission Directive 91/422/EEC of 15 July 1991 adapting to technical progress Council Directive 71/320/EEC on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and their trailers
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 71/320/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and their trailers (1), as last amended by Commission Directive 88/194/EEC (2), and in particular Article 5 thereof,
Whereas in the light of the progress made in braking technology, it is now possible to make the requirements more stringent and, in particular, to make it compulsory to fit certain heavy vehicles and trailers with automatic brake lining adjusters with a view to increasing road safety;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on Motor Vehicles,
Article 1
Annexes I, II, III, IV, V, VII, IX, X and XII to Directive 71/320/EEC are hereby amended in accordance with the Annex to this Directive.
Article 2
1. As from 1 October 1991 no Member State may, on grounds relating to braking devices:
- refuse, in respect of a type of vehicle, to grant EEC type-approval, or to issue the copy of the certificate provided for in the last indent of Article 10 (1) of Council Directive 70/156/EEC (3), or to grant national type-approval, or
- prohibit the entry into service of vehicles,
where the braking devices of such type of vehicle or of such vehicles comply with the provisions of Directive 71/320/EEC, as last amended by this Directive.
2. As from 1 October 1992 Member States:
- shall no longer issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC in respect of a type of vehicle of which the braking devices do not comply with the provisions of Directive 71/320/EEC, as last amended by this Directive,
- may refuse to grant national type-approval of a type of vehicle of which the braking devices do not comply with the provisions of Directive 71/320/EEC, as last amended by this Directive.
3. As from 1 October 1994 Member States may prohibit the entry into service of vehicles of which the braking devices do not comply with the provisions of Directive 71/320/EEC, as last amended by this Directive.
Article 3
Member States shall bring into force the provisions necessary in order to comply with this Directive before 1 October 1991. They shall immediately inform the Commission thereof.
When Member States adopt these provisions these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such a reference shall be adopted by Member States.
Article 4
This Directive is addressed to the Member States. | [
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31991L0414 | 1991 | Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas plant production has a very important place in the Community;
Whereas plant production yields are continually affected by harmful organisms including weeds; whereas it is absolutely essential to protect plants against these risks to prevent a decline in yields and to help to ensure security of supplies;
Whereas one of the most important ways of protecting plants and plant products and of improving agricultural production is to use plant protection products;
Whereas these plant protection products can have non-beneficial effects upon plant production; whereas their use may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorized and if incorrectly used;
Whereas, in view of the hazards, there are rules in most Member States governing the authorization of plant health products; whereas these rules present differences which constitute barriers not only to trade in plant protection products but also to trade in plant products, and thereby directly affect the establishment and operation of the internal market;
Whereas it is therefore desirable to eliminate such barriers by harmonizing the provisions laid down in the Member States;
Whereas uniform rules on the conditions and procedures for the authorization of plant protection products must be applied by the Member States;
Whereas such rules should provide that plant protection products should not be put on the market or used unless they habe been officially authorized and should be used properly having regard to the principles of good plant protection practice and of integrated pest control;
Whereas the provisions governing authorization must ensure a high standard of protection, which, in particular, must prevent the authorization of plant protection products whose risks to health, groundwater and the environment and human and animal health should take priority over the objective of improving plant production;
Whereas it is necessary, at the time when plant protection products are authorized, to make sure that, when properly applied for the purpose intended, they are sufficiently effective and have no unacceptable effect on plants or plant products, no unacceptable influence on the environment in general and, in particular, no harmful effect on human or animal health or on groundwater;
Whereas authorization should be limited to plant protection products containing certain active substances specified at Community level on the basis of their toxicological and ecotoxicological properties;
Whereas it is therefore necessary to establish a Community list of authorized active substances;
Whereas a Community procedure must be laid down for assessing whether an active substance can be entered on the Community list; whereas the information that interested parties must submit with a view to admission of a substance to the list should be specified;
Whereas the Community procedure should not prevent Member States from authorizing for use in their territory for a limited period plant protection products containing an active substance not yet entered on the Community list, provided that the interested party has submitted a dossier meeting Community requirements and the Member State has concluded that the active substance and the plant protection products can be expected to satisfy the Community conditions set in regard to them;
Whereas, in the interests of safety, substances on the Community list should be reviewed periodically, to take account of developments in science and technology and of impact studies based on the actual use of plant protection products containing the said substances;
Whereas it is in the interests of free movement of plant products as well as of plant protection products that authorization granted by one Member State, and tests carried out with a view to authorization, should be recognized by other Member States, unless certain agricultural, plant health and environmental (including climatic) conditions relevant to the use of the products concerned are not comparable in the regions concerned; whereas to this end there is a need to harmonize the methods of experimentation and control applied by the Member States for the purpose of granting authorization;
Whereas it is therefore desirable that a system for the mutual supply of information should be established and that Member States should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorization of plant protection products;
Whereas, however, Member States must be enabled to authorize plant protection products not complying with the abovementioned conditions when it is necessary to do so because of an unforeseeable danger threatening plant production which cannot be countered by other means; whereas such authorization should be reviewed by the Community in close cooperation with the Member States in the framework of the Standing Committee on Plant Health;
Whereas this Directive complements Community provisions on the classification, packaging and labelling of pesticides; whereas together with these provisions it considerably
improves the protection of users of plant protection products and consumers of plants and plant products; whereas it also contributes to the protection of the environment;
Whereas it is necessary to maintain consistency between this Directive and Community rules on the residues of plant protection products in agricultural products and the free movement of the latter in the Community; whereas this Directive complements Community provisions relating to maximum permissible levels for pesticide residues and will facilitate the adoption of such levels in the Commission; whereas together with the latter provisions it considerably improves the protection of consumers of plants and plant products;
Whereas resources devoted to the conduct of tests on vertebrate animals should not be dissipated as a result of the differences in the laws of the Member States and whereas considerations of public interest and Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (4) militate against needless repetition of tests on animals;
Whereas, in order to ensure that the requirements laid down are satisfied, Member States must make provision for appropriate control and inspection arrangements with regard to the marketing and use of plant protection products;
Whereas the procedures provided for by this Directive for the evaluation of the risks to the environment presented by plant protection products containing or composed of genetically modified organisms correspond in principle to those laid down in Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (5); whereas in future however the supply of data in accordance with Part B of Annexes II and III is likely to be subject to specific requirements, provision should be made to amend this Directive accordingly;
Whereas the implementation of this Directive and the adaptation of its Annexes to advances in technical and scientific knowledge necessitate close cooperation between the Commission and the Member States, and whereas the procedure of the Standing Committee on Plant Health offers a suitable basis for this cooperation,
Scope
Article 1
1. This Directive concerns the authorization, placing on the market, use and control within the Community of plant protection products in commercial form and the placing on
(;) OJ No L 358, 18. 12. 1986, p. 1.
($) OJ No L 117, 8. 5. 1990, p. 15.
the market and control within the Community of active substances intended for a use specified in Article 2 (1).
2. This Directive shall apply without prejudice to Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides) (;), as last amended by Directive 84/291/EEC ($) and, where active substances are concerned, without prejudice to the provisions concerning classification, packaging and labelling of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (=), as last amended by Directive 90/517/EEC (%).
3. This Directive applies to the authorization to place on the market plant protection products containing or composed of genetically modified organisms, provided that authorization to release them into the environment has been granted after the risk to the environment has been assessed in accordance with the provisions of Parts A, B and D and the relevant provisions of Part C of Directive 90/220/EEC.
The Commission shall submit to the Council, in sufficient time for the latter to be able to act not later than two years after the date of notification of this Directive, a proposal for an amendment with a view to including in this Directive (& ) a specific procedure for evaluating the risk to the environment analogous to that provided for the Directive 90/220/EEC, and enabling this Directive to be placed on the list provided for in Article 10 (3) of Directive 90/220/EEC in accordance with the procedure laid down in the said Article 10.
Within five years of the date of notification of this Directive, the Commission, on the basis of experience gained, shall provide the European Parliament and the Council with a report on the operation of the arrangements described in the first and second subparagraphs.
4. This Directive shall apply without prejudice to Council Regulation (EEC) No 1734/88 of 16 June 1988 concerning export from and import into the Community of certain dangerous chemicals (().
Definitions
Article 2
For the purposes of this Directive the following definitions shall apply:
1.
'plant protection products'
active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:
(;) OJ No L 206, 29. 7. 1978, p. 13.
($) OJ No L 144, 30. 5. 1984, p. 1.
(=) OJ No 196, 16. 8. 1967, p. 1.
(%) OJ No L 287, 19. 10. 1990, p. 37.
(& ) This Directive was notified to the Member States on 26 July 1991.
(() OJ No L 155, 22. 6. 1988, p. 2.
1.1.
protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;
1.2.
influence the life processes of plants, other than as a nutrient, (e.g. growth regulators);
1.3.
preserve plant products, in so far as such substances or products are not subject to special Council of Commission provisions on preservatives;
1.4.
destroy undesired plants; or
1.5.
destroy parts of plants, check or prevent undesired growth of plants;
2.
'residues of plant protection products'
one or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites and products resulting from their degradation or reaction;
3.
'substances'
chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitable resulting from the manufacturing process;
4.
'active substances'
substances or micro-organisms including viruses, having general or specific action:
4.1.
against harmful organisms; or
4.2.
on plants, parts of plants or plant products;
5.
'preparations'
mixtures or solutions composed of two or more substances of which at least one is an active substance, intended for use as plant protection products;
6.
'plants'
live plants and live parts of plants, including fresh fruit and seeds;
7.
'plant products'
products in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, derived from plants, but excluding plants themselves as defined in point 6;
8.
'harmful organisms'
pests of plants or plant products belonging to the animal or plant kingdom, and also viruses, bacteria and mycoplasmas and other pathogens;
9.
'animals'
animals belonging to species normally fed and kept or consumed by man;
10.
'placing on the market'
any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the Community or disposal. Importation of a plant protection product into the territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive;
11.
'authorization of a plant protection product'
administrative act by which the competent authority of a Member State authorizes, following an application submitted by an applicant, the placing on the market of a plant protection product in its territory or in a part thereof;
12.
'environment'
water, air, land, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms;
13.
'integrated control'
the rational application of a combination of biological, biotechnological, chemical, cultural or plant-breeding measures whereby the use of chemical plant protection products is limited to the strict minimum necessary to maintain the pest population at levels below those causing economically unacceptable damage or loss.
General provisions
Article 3
1. Member States shall prescribe that plant protection products may not be placed on the market and used in their territory unless they have authorized the product in accordance with this Directive, except where the intended use is covered by Article 22.
2. Member States shall not, on the grounds that a plant protection product is not authorized for use in their territory, impede the production, storage or movement of such products intended for use in another Member State, provided that:
- the product is authorized in another Member State, and
- the inspection requirements laid down by the Member States in order to ensure compliance with paragraph 1 are satisfied.
3. Member States shall prescribe that plant protection products must be used properly. Proper use shall include compliance with the conditions established in accordance with Article 4 and specified on the labelling, and the application of the principles of good plant protection practice as well as, whenever possible, the principles of integrated control.
4. Member States shall prescribe that active substances may not be placed on the market unless:
- they are classified, packaged and labelled in accordance with Directive 67/548/EEC, and
- where the active substance was not on the market two years after notification of this Directive, a dossier has been forwarded to the Member States and to the Commission, in accordance with Article 6, with the declaration that the active substance is intended for a use specified in Article 2 (1). This condition shall not apply to active substances intended for a use under Article 22.
Granting, review and withdrawal of authorizations of plant protection products
Article 4
1. Member States shall ensure that a plant protection product is not authorized unless:
(a) its active substances are listed in Annex I and any conditions laid down therein are fulfilled,
and, with regard to the following points (b), (c), (d) and (e), pursuant to the uniform principles provided for in Annex VI, unless:
(b)
it is established, in the light of current scientific and technical kowledge and shown from appraisal of the dossier provided for in Annex III, that when used in accordance with Article 3 (3), and having regard to all normal conditions under which it may be used, and to the consequences of its use:
ii(i) it is sufficiently effective;
i(ii)
it has no unacceptable effect on plants or plant products;
(iii)
it does not cause unnecessary suffering and pain to vertebrates to be controlled;
(iv)
it has no harmful effect on human or animal health, directly or indirectly (e.g. through drinking water, food or feed) or on groundwater;
i(v)
it has no unacceptable influence on the environment, having particular regard to the following considerations:
- its fate and distribution in the environment, particularly contamination of water including drinking water and groundwater,
- its impact on non-target species;
(c)
the nature and quantity of its active substances
and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants can be determined by appropriate methods, harmonized according to the procedure provided in Article 21, or, if not, agreed by the authorities responsible for the authorization;
(d)
its residues, resulting from authorized uses, and which are of toxicological or environmental significance, can be determined by appropriate methods in general use;
(e)
its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product;
(f)
maximum residue levels in the agricultural products referred to in the authorization have been provisionally established by the Member State and notified to the Commission in accordance with Article 12; within three months of the said notification, the Commission shall consider whether the provisional maximum levels established by the Member State are acceptable, and in accordance with the procedure laid down in Article 19 it shall establish provisional maximum levels throughout the Community and these shall remain in force until the corresponding maximum levels are adopted pursuant to the procedure provided for in the second subparagraph of Article 1 (1) of Directive 90/462/EEC (;) and in Article 11 of Directive 86/362/EEC ($), as amended by Directive 88/298/EEC (=).
In particular:
i(i) Member States may not prohibit or impede the introduction into their territory of products containing pesticide residues provided the residue level does not exceed the provisional maximum levels set in accordance with the first subparagraph;
(ii)
Member States must ensure that the conditions for approval are applied in such a way that the provisional maximum levels are not exceeded.
2. The authorization must stipulate the requirements relating to the placing on the market and use of the product or at least those aimed at ensuring compliance with the provisions of paragraph 1 (b).
3. Member States shall ensure that compliance with the requirements set out in paragraph 1 (b) to (f) is established by
(;) OJ No L 350, 14. 12. 1990, p. 71.
($) OJ No L 221, 7. 8. 1986, p. 36.
(=) OJ No L 126, 20. 5. 1988, p. 53.
official or officially recognized tests and analyses carried out under agricultural, plant health and environmental conditions relevant to use of the plant protection product in question and representative of these prevailing where the product is intended to be used, within the territory of the Member State concerned.
4. Without prejudice to paragraphs 5 and 6, authorizations shall be granted for a fixed period of up to 10 years only, determined by the Member States; they may be renewed after verification that the conditions imposed in paragraph 1 are still satisfied. Renewal may be granted for the period necessary to the competent authorities of the Member States, for such verification, where an application for renewal has been made.
5. Authorizations may be reviewed at any time if there are indications that any of the requirements referred to in paragraph 1 are no longer satisfied. In such instances the Member States may require the applicant for authorization or party to whom an extension of the field of application was granted in accordance with Article 9 to submit further information necessary for the review. The authorization may, where necessary, be extended for the period necessary to complete a review and provide such further information.
6. Without prejudice to Decisions already taken pursuant to Article 10, an authorization shall be cancelled if it is established that:
(a) the requirements for obtaining the authorization are not or are no longer satisfied;
(b)
false or misleading particulars were supplied concerning the facts on the basis of which the authorization was granted;
or modified if it is established that:
(c)
on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified.
It may also be cancelled or modified at the request of the holder of the authorization, who shall state the reasons therefor; amendments can be granted only if it is established that the requirements of Article 4 (1) continue to be satisfied.
Where a Member State withdraws an authorization, it shall immediately inform the holder of the authorization; moreover, it may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks, of a length in accordance with the reason for the withdrawal, without prejudice to any period provided for by decision taken under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (%), as last amended by Directive 90/335/EEC (& ), or Article 6 (1) or Article 8 (1) or (2) of this Directive.
(%) OJ No L 33, 8. 2. 1979, p. 36.
(& ) OJ No L 162, 28. 6. 1990, p. 37.
Inclusion of active substances in Annex I
Article 5
1. In the light of current scientific and technical knowledge, an active substance shall be included in Annex I for an initial period not exceeding 10 years, if it may be expected that plant protection products containing the active substance will fulfil the following conditions:
(a) their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, and the said residues, in so far as they are of toxicological or environmental significance, can be measured by methods in general use;
(b) their use, consequent on application consistent with good plant protection practice, does not have any harmful effects on human or animal health or any anacceptable influence on the environment as provided for in Article 4 (1) (b) (iv) and (v).
2. For inclusion of an active substance in Annex I, the following shall be taken into particular account:
(a) where relevant, an acceptable daily intake (ADI) for man;
(b)
an acceptable operator exposure level if necessary;
(c)
where relevant, an estimate of its fate and distribution in the environment as well as its impact on non-target species.
3. For the first inclusion of an active substance which was not yet on the market two years after notification of this Directive, the requirements shall be deemed to be satisfied where this has been established for at least one preparation containging the said active substance.
4. Inclusion of an active substance in Annex I may be subject to requirements such as:
- the minimum degree of purity of the active substance,
- the nature and maximum content of certain impurities,
- restrictions arising from evaluation of the information referred to in Article 6, taking account of the agricultural, plant health and environmental (including climatic) conditions in question,
- type of preparation,
- manner of use.
5. On request, the inclusion of a substance in Annex I may be renewed once or more for periods not exceeding 10 years; such inclusion may be reviewed at any time if there are
indications that the criteria referred to in paragraphs 1 and 2 are no longer satisfied. Renewal shall be granted for the period necessary to complete a review, where an application has been made for such renewal in sufficient time, and in any case not less than two years before the entry is due to lapse, and shall be granted for the period necessary to provide information requested in accordance with Article 6 (4).
Article 6
1. Inclusion of an active substance in Annex I shall be decided in accordance with the procedure laid down in Article 19.
The following shall also be decided in accordance with that procedure:
- any conditions for inclusion,
- amendements to Annex I, where necessary,
- removal of an active substance form Annex I if it no longer satisfies the requirements of Article 5 (1) and (2).
2. A Member State receiving an application for the inclusion of an active substance in Annex I shall without undue delay ensure that a dossier which is believed to satisfy the requirements of Annex II is forwarded by the applicant to the other Member States and to the Commission together with a dossier complying with Annex III on at least one preparation containing that active substance. The Commission shall refer the dossier to the Standing Committee on Plant Health referred to in Article 19 for examination.
3. Without prejudice to the provisions of paragraph 4, at the request of a Member State, and within three to six months after the date of referral to the committee mentioned in Article 19, it shall be established by the procedure laid down in Article 20 whether the dossier has been submitted in accordance with the requirements of Annexes II and III.
4. If the assessment of the dossier referred to in paragraph 2 shows that further information is necessary, the Commission may ask the applicant to submit such information. The applicant or his authorized representative may be asked by the Commission to submit his remarks to it, in particular whenever an unfavourable decision is envisaged.
These provisions shall also apply if, after inclusion of an active substance in Annex I, facts emerge that cast doubt on its conformity with the requirements indicated in Article 5 (1) and (2), or if renewal in accordance with Article 5 (5) is being considered.
5. The procedure concerning the submission and appraisal of applications for inclusion in Annex I and setting or varying any conditions for inclusion shall be adopted in accordance with the procedure laid down in Article 21.
Information on potentially harmful effects
Article 7
Member States shall prescribe that the holder of an authorization or those to whom an extension of the field of application has been granted in accordance with Article 9 (1) must immediately notify the competent authority of all new information on the potentially dangerous effects of any plant protection product, or of residues of an active substance on human or animal health or on groundwater, or their potentially dangerous effects on the environment. Member States shall ensure that the parties concerned immediately notify this information to the other Member States and to the Commission, which shall refer the information to the committee referred to in Article 19.
Transitional measures and derogations
Article 8
1. By way of derogation from Article 4, a Member State may, to enable a gradual assessment to be made of the properties of new active substances and to make it easier for new preparations to be made available for use in agriculture, authorize, for a provisional period not exceeding three years, the placing on the market of plant protection products containing an active substance not listed in Annex I and not yet available on the market two years after notification of this Directive, provided that:
(a) following application of Article 6 (2) and (3) it is found that the dossier on the active substance satisfies the requirements of Annexes II and III in relation to the projected uses;
(b) the Member State establishes that the active substance can satisfy the requirements of Article 5 (1) and that the plant protection product may be expected to satisfy the requirements of Article 4 (1) (b) to (f).
In such cases the Member State shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorization, giving at least the information provided for in Article 12 (1).
Following the evaluation of the dossier as provided for in Article 6 (3), it may be decided, in accordance with the procedure laid down in Article 19, that the active substance does not satisfy the requirements specified in Article 5 (1). In such cases the Member States shall ensure that the authorizations must be withdrawn.
By way of derogation from Article 6, if, on expiry of the three-year period, a decision has not been taken concerning the inclusion of an active substance in Annex I, a further period may be ordered by the procedure referred to in Article 19 to enable a full examination to be made of the dossier and, where appropriate, of any additional information requested in accordance with Article 6 (3) and (4).
The provisions of Article 4 (2), (3), (5) and (6) shall apply to authorizations granted under the terms of this paragraph without prejudice to the foregoing subparagraphs.
2. By way of derogation from Article 4 and without prejudice to paragraph 3 or to Directive 79/117/EEC, a Member State may, during a period of 12 years following the notification of this Directive, authorize the placing on the market in its territory of plant protection products containing active substances not listed in Annex I that are already on the market two years after the date of notification of this Directive.
After the adoption of this Directive, the Commission
shall commence a programme of work for the gradual examination of these active substances within the 12-year period referred to in the foregoing subparagraph. This programme may require interested parties to submit all requisite data to the Commission and the Member States within a period provided for in the programme. A Regulation, adopted according to the procedure laid down in Article 19, will set out all the provisions necessary for the implementation of the programme.
Ten years following notification of this Directive the Commission shall present to the European Parliament and the Council a progress report on the programme. Depending upon the conclusions of the report, it may be decided, according to the procedure laid down in Article 19, whether, for certain substances, the 12-year period referred to in the first subparagraph is to be extended for a period to be determined.
During the 12-year period referred to in the first subparagraph it may, following examination by the Committee referred to in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance can be included in Annex I and under which conditions, or, in cases where the requirements of Article 5 are not satisfied or the requisite information and data have not been submitted within the prescribed period, that such active substance will not be included in Annex I. The Member States shall ensure that the relevant authorizations are granted, withdrawn or varied, as appropriate, within a prescribed period.
3. Where they review plant protection products containing an active substance in accordance with paragraph 2, and before such review has taken place, Member States shall apply the requirements laid down in Article 4 (1) (b) (i) to (v), and (c) to (f) in accordance with national provisions concerning the data to be provided.
4. By way of further derogation from Article 4, in special circumstances a Member State may authorize for a period not exceeding 120 days the placing on the market of plant protection products not complying with Article 4 for a limited and controlled use if such a measure appears necessary because of an unforeseeable danger which cannot be contained by other means. In this case, the Member State concerned shall immediately inform the other Member States
and the Commission of its action. It shall be decided without delay, in accordance with the procedure laid down in Article 19, whether and under which conditions the action taken by the Member State may be extended for a given period, repeated, or revoked.
Application for authorization
Article 9
1. Application for authorization of a plant protection product shall be made by or on behalf of the person responsible for first placing it on the market in a Member State to the competent authorities of each Member State where the plant protection product is intended to be placed on the market.
Official or scientific bodies involved in agricultural activities or professional agricultural organizations and professional users may request that the field of application of a plant protection product already authorized in the Member State in question be extended to purposes other than those covered by this authorization.
Member States shall grant an extension of the field of application of an authorized plant protection product and shall be obliged to grant such an extension when it is in the public interest to the extent that:
- the documentation and information to support an extension of the field of application has been submitted by the applicant,
- they have established that the conditions referred to in Article 4 (1) (b) (iii), (iv) and (v) are satisfied,
- the intended use is minor in nature,
- users are fully and specifically informed as to instructions for use, by means of an addition to the labelling or, failing that, by means of an official publication.
2. Every applicant shall be required to have a permanent office within the Community.
3. Member States may require that applications for authorization be submitted in their national or official languages or one of those languages. They may also require that samples of the preparation and of its ingredients be provided.
4. Each Member State shall agree to consider any application for authorization made to it and shall decide thereon within a reasonable period, provided that it has the necessary scientific and technical structures at its disposal.
5. Member States shall ensure that a file is compiled on each application. Each file shall contain at least a copy of the
application, a record of the administrative decisions taken by the Member State concerning the application and concerning the particulars and documentation laid down in Article 13 (1) together with a summary of the latter. Member States shall on request make available to the other Member States and to the Commission the files provided for in this paragraph; they shall supply to them on request all information necessary for full comprehension of applications, and shall where requested ensure that applicants provide a copy of the technical documentation laid down in Article 13 (1) (a).
Mutual recognition of authorizations
Article 10
1. At the request of the applicant, who must substantiate the claim to comparability with documentary evidence, a Member State to which an application is made for the authorization of a plant protection product already authorized in another Member State must:
- refrain from requiring the repetition of tests and analyses already carried out in connection with the authorization of the product in that Member State, and to the extent that agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product are comparable in the regions concerned, and
- to the extent that the uniform principles have been adopted in accordance with Article 23, where the product contains only active substances listed in Annex I, also authorize the placing of that product on the market in its territory, to the extent that agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product are comparable in the regions concerned.
Authorization may be subject to conditions resulting from the implementation of other measures in accordance with Community law, relating to the conditions for distribution and use of plant protection products intended to protect the health of the distributors, users and workers concerned.
Subject to compliance with the Treaty, authorization may also be accompanied by restrictions on use arising from differences in dietary patterns and necessary in order to avoid exposure of consumers of treated products to the risks of dietary contamination in excess of the acceptable daily intake of the residues concerned.
Authorization may be subject, with the agreement of the applicant, to changes in the conditions of use in order to render, in the regions concerned, any non-comparable agricultural, plant health or environmental (including climatic) conditions irrelevant for the purpose of comparability.
2. Member States shall inform the Commission of cases where they have required repetition of a test and of cases where they have refused to authorize a plant protection product already authorized in another Member State, in respect of which the applicant had claimed that the agricultural, plant health and environmental (including climatic) conditions relevant to use of the product in the regions concerned in the Member State where the test was carried out or for which authorization was granted were comparable to those in their own territory. They shall notify the Commission of the grounds on which repetition of the test was required or authorization was refused.
3. Without prejudice to Article 23, in cases where a Member State refuses to recognize comparability and accept tests and analyses or authorize the placing on the market of a plant protection product in the relevant regions of its territory, the decision as to whether or not comparability exists shall be taken in accordance with the procedure laid down in Article 19 and, if the decision is negative, it shall also specify the conditions of use under which the non-comparability may be deemed irrelevant. In this procedure account shall be taken, inter alia, of the serious ecological vulnerability problems that may arise in certain Community regions or zones thereby requiring, if they do arise, specific protection measures. The Member State shall without delay accept the tests and analyses or authorize the placing of the plant protection product on the market, subject in the latter case to any terms which the above decision may set.
Article 11
1. Where a Member State has valid reasons to consider that a product which it has authorized or is bound to authorize under Article 10 constitutes a risk to human or animal health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision.
2. A decision shall be taken on the matter within three months in accordance with theprocedure laid down in Article 19.
Exchange of information
Article 12
1. Within a period of one month at the end of each quarter at least, Member States shall inform each other and the Commission in writing of any plant protection products
authorized or withdrawn, in accordance with the provisions of this Directive, indicating at least:
- the name or business name of the holder of the authorization,
- the trade name of the plant protection product,
- the type of preparation,
- the name and amount of each active substance which it contains,
- the use or uses for which it is intended,
- the maximum residue levels provisionally established where they have not already been set by Community rules,
- where relevant, the reasons for withdrawal of an authorization,
- the dossier needed for the evaluation of the maximum residue levels provisionally established.
2. Each Member State shall draw up an annual list of the plant protection products authorized in its territory and shall communicate that list to the other Member States and the Commission.
In accordance with the procedure laid down in Article 21 a standardized information system shall be set up to facilitate the application of paragraphs 1 and 2.
Data requirements, data protection and confidentiality
Article 13
1. Without prejudice to Article 10, Member States shall require that applicants for authorization of a plant protection product submit with their application:
(a) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III; and
(b) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II.
2. By way of derogation from paragraph 1, and without prejudice to the provisions of paragraphs 3 and 4, applicants shall be exempted from supplying the information required under paragraph 1 (b) except for that identifying the active substance if the active substance is already listed in Annex I, taking into account the conditions of inclusion in Annex I, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the dossier accompanying the original application.
3. In granting authorizations, Member States shall not make use of the information referred to in Annex II for the benefit of other applicants:
(a) unless the applicant has agreed with the first applicant that use may be made of such information; or
(b)
for a period of 10 years from first inclusion in Annex I of an active substance not on the market two years after the date of notification of this Directive; or
(c)
for periods not exceeding 10 years from the date of the decision in each Member State and provided for in existing national rules, concerning an active substance on the market two years after the date of notification of this Directive; and
(d)
for a period of five years from the date of a decision, following receipt of further information necessary for first inclusion in Annex I, which has been taken either to vary the conditions for, or to maintain, the inclusion of an active substance in Annex I, unless the five-year period expires before the period provided for in paragraphs 3 (b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods.
4. In granting authorizations, Member States shall not make use of the information referred to in Annex III to the benefit of other applicants:
(a) unless the applicant has agreed with the first applicant that use may be made of such information; or
(b)
for a period of 10 years from first authorization of the plant protection product in any Member State, where authorization follows the inclusion in Annex I of any active substance contained in the product; or
(c)
for periods not exceeding 10 years and provided for in existing national rules after the first authorization of the plant protection product in each Member State, where that authorization precedes inclusion in Annex I of any active substance contained in the product.
5. Member States, on examination of an application for authorization, shall inform the Commission of instances where they consider an active substance to be listed in Annex I, which has been produced by a person or manufacturing process other than those specified in the dossier on the basis of which the active substance was first included in Annex I. They shall transmit to it all data regarding the identify and impurities of the active substance.
6. By way of derogation from paragraph 1, for active substances already on the market two years after notification of this Directive, Member States may, with due regard for the provisions of the Treaty, continue to apply previous national rules concerning data requirements as long as such substances are not included in Annex I.
7. Notwithstanding paragraph 1, and without prejudice to Article 10, where the active substance is listed in Annex I:
(a) applicants for authorization of plant protection products shall, before carrying out experiments involving vertebrate animals, enquire of the competent authority of the Member State to which they intend making application:
- whether the plant protection product for which an application is to be made is the same as a plant protection product for which authorization has been granted, and
- as to the name and address of the holder or holders of the authorization or authorizations.
The enquiry shall be supported by evidence that the prospective applicant intends to apply for authorization on his own behalf and that the other information specified in paragraph 1 is available;
(b) the competent authority of the Member State, if satisfied that the applicant intends to apply, shall provide the name and address of the holder or holders of previous relevant authorizations and shall at the time inform the holders of the authorizations of the name and address of the applicant.
The holder or holders of previous authorizations and the applicant shall take all reasonable steps to reach agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.
Where data is requested with a view to inclusion in Annex I of an active substance already on the market two years after notification of this Directive, the competent authorities of the Member State shall encourage data holders to cooperate in the provision of the requested data, with a view to limiting the duplication of testing on vertebrate animals.
If, nevertheless, the applicant and holders of previous authorizations of the same product can still not reach an agreement on the sharing of data, Member States may introduce national measures obliging the applicant and holders of previous authorizations located within their territory to share the data with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilizing information, and the reasonable balance of the interests of the parties concerned.
Article 14
Member States and the Commission shall, without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (6), ensure that information submitted by applicants involving industrial and commercial secrets is treated as confidential if the applicant wishing to have an active substance included in Annex I or the applicant for authorization of a plant protection product so requests, and if the Member State or the Commission accepts that the applicant's request is warranted.
Confidentiality shall not apply to:
- the names and content of the active substance or substances and the name of the plant protection product,
- the name of other substances which are regarded as dangerous under Directives 67/548/EEC and 78/631/EEC,
- physico-chemical data concerning the active substance and plant protection product,
- any ways of rendering the active substance or plant protection product harmless,
- a summary of the results of the tests to establish the substance's or product's efficacy and harmlessness to humans, animals, plants and the environment,
- recommended methods and precautions to reduce handling, storage, transport, fire or other hazards,
- methods of analysis referred to in Articles 4 (1) (c) and (d) and 5 (1),
- methods of disposal of the product and of its packaging,
- decontamination procedures to be followed in the case of accidential spillage or leakage,
- first aid and medical treatment to be given in the case of injury to persons.
If the applicant subsequently discloses previously confidential information, he shall be required to inform the competent authority accordingly.
Packaging and labelling of plant protection products
Article 15
Article 5
(1) of Directive 78/631/EEC shall apply to all plant protection products not covered by Directive 78/631/EEC.
Article 16
Member States shall take all necessary measures to ensure that the packaging of plant protection products satisfies the following requirements as to labelling.
1. All packaging must show clearly and indelibly the following:
(a) the trade name or designation of the plant protection product;
(b)
the name and address of the holder of the authorization and the authorization number of the plant protection product and, if different, the name
and address of the person responsible for the final packaging and labelling or for the final labelling of the plant protection product on the market;
(c)
the name and amount of each active substance expressed as provided for in Article 6 of Directive 67/548/EEC and in particular paragraph (2) (d) of that Article.
The name must be as given in the list contained in Annex I to Directive 67/548/EEC or, if not included therein, its ISO common name. If the latter is not available, the active substance shall be designated by its chemical designation according to IUPAC rules;
(d)
the net quantity of plant protection product given in legal units of measurement;
(e)
the formulation batch number or some means of identifying it;
(f)
the particulars required under Article 6 of Directive 78/631/EEC, in particular those mentioned in paragraph 2 (d), (g), (h) and (i), and paragraphs 3 and 4 of that Article and information on first aid;
(g)
the nature of any special risks for humans, animals or the environment, by means of standard phrases selected as appropriate from those given in Annex IV;
(h)
safety precautions for the protection of humans, animals or the environment, in the form of standard phrases selected as appropriate from those given in Annex V;
(i)
the type of action of the plant protection product (e.g. insecticide, growth regulator, weedkiller, etc.);
(j)
the type of preparation (e.g. wettable powder, emulsifiable concentrate, etc.);
(k)
the uses for which the plant protection product has been authorized and any specific agricultural, plant health and environmental conditions under which the product may be used or should not be used;
(l)
directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorization;
(m)
where necessary, the safety interval for each use between application and:
- sowing or planting of the crop to be protected,
- sowing or planting of succeeding crops,
- access by humans or animals,
- harvesting,
- use or consumption;
(n)
particulars of possible phytotoxicity, varietal susceptibility, and any other direct or indirect
adverse side effects on plants or products of plant origin together with the intervals to be observed between application and sowing or planting of:
- the crop in question, or
- subsequent crops;
(o)
if accompanied by a leaflet, as provided for in paragraph 2, the sentence 'Read accompanying instructions before use';
(p)
directions for safe disposal of the plant protection product and of the packaging; and
(q)
the expiry date relevant to normal conditions of storage where the shelf life of the product is limited to less than two years.
2. Member States may permit the requirements in paragraph 1 (l), (m) and (n) to be indicated on a separate leaflet accompanying the package if the space available on the package is too small. Such a leaflet shall be regarded as part of the label for the purposes of this Directive.
3. Taking account of the rules in force within their territories regarding the supply of certain plant protection products to certain categories of users, pending Community harmonization, the Member States shall require that it be indicated on the label whether a product is restricted to certain categories of users.
4. In no circumstances may the label of the packaging of a plant protection product bear the indications 'non-toxic', 'harmless', or similar indications. However, information to the effect that the plant protection product may be used when bees or other non-target species are active, or when crops or weeds are in flower or other such phrases to protect bees or other non-target species may be given on the label, if the authorization relates explicitly to use during the season for bees or other specified organisms and presents minimal hazard to them.
5. Member States may make the placing of plant protection products on the market in their territories subject to their being labelled in their national language or languages, and may require that samples, models or drafts of the packaging, labelling and leaflets referred to in this Article be submitted.
By way of derogation from paragraph 1 (g) and (h), Member States may require additional phrases to be clearly and indelibly marked on packaging where they are deemed to be necessary for the protection of human beings, animals or the environment; in that event they shall notify the other Member States and the
Commission forthwith of each derogation granted and shall forward the additional phrase or phrases and the reasons for these requirements.
In accordance with the procedure laid down in Article 19, a decision shall be taken that the additional phrase or phrases is or are justified and hence that Annexes IV and V must be amended accordingly, or that the Member States concerned must no longer require such phrase(s). The Member State shall be entitled to maintain its requirement until such time as a decision has been taken.
Control measures
Article 17
Member States shall make the necessary arrangements for plant protection products which have been placed on the market and for their use to be officially checked to see whether they comply with the requirements of this Directive and in particular with the requirements of the authorization and information appearing on the label.
The Member States shall report annually before 1 August to the other Member States and the Commission on the results of the inspection measures taken in the previous year.
Administrative provisions
Article 18
1. The Council, acting by a qualified majority on a proposal from the Commission, shall adopt the 'uniform principles' referred to in Annex VI.
2. In accordance with the procedure laid down in Article 19 and having regard to current scientific and technical knowledge, the necessary amendments to Annexes II, III, IV, V and VI shall be adopted.
Article 19
Where the procedure laid down in this Article is to be followed, matters shall be referred without delay by the chairman, either on his own initiative or at the request of a Member State, to the Standing Committee on Plant Health, set up by Decision 76/894/EEC (7), herinafter referred to as 'the Committee'.
The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the
majority laid down in Article 148 (2) of the Treaty. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 20
Where the procedure laid down in this Article is to be followed, matters shall be referred by the chairman, either on his own initiative or at the request of a Member State, to the committee.
The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of 15 days from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 21
Where the procedure laid down in this Article is to be followed, matters shall be referred by the Chairman, either on his own initiative or at the request of a Member State, to the committee.
The representative of the Commission shall submit to the committee a draft of the measures to be taken. The
committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.
Research and development
Article 22
1. The Member States shall prescribe that any experiment or test for research or development purposes involving the release into the environment of an unauthorized plant protection product may only be carried out after authorization for trial purposes has been granted and under controlled conditions and for limited quantities and areas.
2. The persons concerned shall submit an application to the competent authority of the Member State in whose territory the experiment or test is to be conducted, within time periods prescribed by the Member State before the commencement of the experiment or test, together with a dossier containing all the available data to permit an assessment to be made of possible effects on human or animal health or the possible impact on the environment.
If the proposed experiments or tests referred to in paragraph 1 are liable to have harmful effects on human or animal health or to have an unacceptable adverse influence on the environment, the Member State concerned may either prohibit them or permit them subject to such conditions as it considers necessary to prevent those consequences.
3. Paragraph 2 shall not apply if the Member State has granted the person concerned the right to undertake certain experiments and tests and has determined the conditions under which the experiments and tests have to be undertaken.
4. Common conditions for the application of this Article, in particular the maximum quantities of pesticides that may be released during experiments covered by paragraph 1, and the minimum data to be submitted in accordance with paragraph 2, shall be adopted in accordance with the procedure laid down in Article 19.
5. This Article shall not apply to experiments or tests covered by Part B of Directive 90/220/EEC.
Implementation of the Directive
Article 23
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within two years following notification thereof. They shall immediately inform the Commission thereof. The uniform principles shall be adopted one year after the date of notification.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Paragraph 1 notwithstanding, Member States need not bring into force laws, regulations and administrative
provisions implementing Article 10 (1), second indent, until one year at the latest following adoption of the uniform principles, and only in relation to the requirements of Article 4 (1) (b) to (e) which are covered by the uniform principles thus adopted.
Article 24
This Directive is addressed to the Member States. | [
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31991L0496 | 1991 | Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Whereas live animals are included in the list in Annex II to the Treaty;
Whereas laying down principles at Community level on the organization of veterinary checks on animals coming from third countries helps to safeguard supplies and ensure market stability while also harmonizing the measures necessary to ensure the protection of animal health;
Whereas Article 23 of Council Directive 90/425/EEC of
26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (3) provides, in particular, that the Council must lay down the rules and general principles applicable to checks on imports from third countries of animals covered by the said Directive;
Whereas each consignment of animals from third countries must be subjected to documentary and identity checks upon entry into the territory of the Community;
Whereas principles valid throughout the Community should be fixed concerning the organization and follow-up of physical checks to be carried out by the competent veterinary authorities;
Whereas provision must be made for safeguard arrangements; whereas, in this context, the Commission must be able to act, particularly by visiting the places concerned and adopting measures appropriate to the circumstances;
Whereas, if the checking system is to function smoothly there must be an approval procedure and border inspection posts must be inspected and there should by exchanges of officials empowered to carry out checks on live animals coming from third countries;
Whereas the laying down of common principles at Community level is all the more necessary given that, with the completion of the internal market in prospect, internal border controls are to be abolished;
Whereas Directives 89/662/EEC (4), 90/425/EEC, and 90/675/EEC should be amended in order to adapt them to this Directive;
Whereas the provision of certain transitional measures of limited duration appears to be necessary in order to facilitate the transition to the new checking arrangements instituted by this Directive;
Whereas the task of adopting measures for the application of this Directive should be entrusted to the Commission,
Article 1
1. Veterinary checks in respect of animals from third countries entering the Community shall be carried out by the Member States in accordance with this Directive.
2. This Directive shall not apply to veterinary checks on family pets accompanying travellers for non-commercial purposes, other than equidae.
Article 2
1. For the purposes of this Directive, the definitions contained in Article 2 of Directive 90/425/EEC shall apply as necessary.
2. In addition:
(a) 'documentary check' shall mean verification of the veterinary certificates or documents accompanying an animal;
(b)
'identity check' shall mean verification, by visual inspection only, for consistency between the documents or certificates and the animals and for the presence and conformity of the marks which must appear on the animals;
(c)
'physical check' shall mean a check of the animal itself, possibly including sampling and laboratory testing
and, where appropriate, additional checks during quarantine;
(d)
'importer' shall mean any natural or legal person who
presents animals for importation into the Community;
(e)
'consignment' shall mean a quantity of animals of the same species, covered by the same veterinary certificate or document, conveyed by the same means of transport and coming from the same third country or same part of such country;
(f)
'border inspection post' shall mean any inspection post located in the immediate vicinity of the external border of one of the territories referred to in Annex I to Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (5) and designated and approved in accordance with Article 6.
CHAPTER I Organization and follow-up of checks
Article 3
1. Member States shall ensure that:
(a) importers are obliged to give one working day's notice to the veterinary staff of the border inspection post where the animals are to be presented specifying the number, nature and estimated time of arrival of the animals;
(b)
the animals are conveyed directly, under official supervision, to the border inspection post referred to
in Article 6 or, where applicable, to a quarantine centre
as provided for in the second indent of the first subparagraph of Article 10 (1);
(c)
the animals may not leave such post or centre unless, without prejudice to the special provisions to be adopted in accordance with the procedure provided for in Article 23, proof has been supplied:
(i) in the form of the certificate provided for in the second indent of Article 7 (1) or in Article 8, that the veterinary checks have been carried out on
the animals in question in accordance with Article 4 (1) and (2) (a), (b) and (d) and Articles 8 and 9 to the satisfaction of the competent authority;
(;) OJ No L 373, 31. 12. 1990, p. 1.
(ii)
that the veterinary checks have been paid for, and that, where relevant, a deposit covering any cost provided for in the second and third indents of Article 10 (1), Article 10 (6) and Article 12 (2) has been lodged;
(d)
the customs authority does not authorize release for free circulation in the territories referred to in Annex I to Directive 90/675/EEC unless, without prejudice to the specific provisions to be adopted in accordance with the procedure laid down in
Article 23, proof has been supplied that the requirements in (c) have been fulfilled.
2. Detailed rules for implementing this Article shall be adopted, as the need arises, in accordance with the procedure laid down in Article 23.
Article 4
1. Member States shall ensure that, irrespective of the customs destination of the animals, each consignment of animals from a third country is subjected by the veterinary authority to a documentary check and identity check at one of the border inspection posts situated in one of the territories referred to in Annex I to Directive 90/675/EEC and approved for that purpose, in order to verify:
- their origin,
- their subsequent destination, particularly in the case of transit or in the case of animals, trade in which has not been harmonized at Community level or which are subject to specific requirements recognized by a Community decision in respect of the Member State of destination,
- that the particulars which appear on the certificates or documents afford the guarantees required by Community rules or, in the case of animals, trade in which has not been harmonized at Community level, the guarantees required under the national rules applicable in the various cases covered by this Directive.
2. Without prejudice to the exemptions pursuant to
Article 8, the official veterinarian must carry out a physical check on animals presented at the border inspection post. That check must include, in particular:
(a) a clinical examination of the animals in order to ensure that they conform to the information provided in the accompanying certificate or document and that they are clinically healthy.
In accordance with the procedure laid down in
Article 23, derogation may be made, subject to certain conditions and in accordance with rules to be established under the same procedure, from the principle of individual clinical examination in respect of certain categories and species of animals;
(b)
any laboratory tests which it is thought necessary should be carried out or which are provided for by Community rules;
(c)
possible official samples to be examined for residues and analysed as soon as possible;
(d) verification of compliance with the minimum requirements laid down by Council Directive 77/489/EEC of 18 July 1977 on the protection of animals during international transport (6).
For the purposes of a subsequent check on transport and, where appropriate, on compliance with the additional requirements of the holding of destination, the official veterinarian shall communicate the necessary information to the competent authorities of the Member State of destination by means of the information exchange system provided for in Article 20 of Directive 90/425/EEC.
The official veterinarian may be assisted in certain of these tasks by qualified staff with special training, working under his direction.
3. However, by way of derogation from paragraphs 1 and 2, for animals entering a port or an airport in the territory defined in Annex I to Directive 90/675/EEC, the identity check and the physical check may be carried out at such port or airport of destination, provided that such port or airport has a border inspection post as referred to in Article 6, and that the animals continue their journey, as the case may be, by sea or by air in the same vessel or in the same aircraft. In such cases, the competent authority which carried out the documentary check shall, either directly or through the local veterinary authority, inform the official veterinarian of the inspection post of the Member State of destination by means of the information exchange system referred to in Article 20 of Directive 90/425/EEC that the animals have passed through.
4. All expenditure incurred by the application of this Article shall be chargeable to the consignor, the consignee or their agent, without reimbursement by the Member State.
5. The detailed rules for applying this Article, including those relating to the training and qualification of assistants, shall be adopted, as the need arises, in accordance with the procedure laid down in Article 23.
Article 5
Entry into one of the territories defined in Annex I to Directive 90/675/EEC shall be prohibited where the checks show that:
(a) animals of species in respect of which import rules have been harmonized at Community level come, without prejudice to the special conditions provided for in Article 19 of Directive 90/426/EEC (7) as concerns the movement and import of equidae coming from third countries, from a territory or part of a territory of a third country not included in the lists drawn up in accordance with Community rules for the species concerned or from which imports are prohibited pursuant to a Community decision;
(b)
animals other than those referred to in (a) do not comply with the requirements provided for in the national rules corresponding to the various cases covered by this Directive;
(c)
animals are suffering from or are suspected to be suffering from or infected by a contagious disease or a disease presenting a risk for public health or animal health, or any other reason provided for in Community rules;
(d)
the exporting third country has not complied with the requirements provided for in Community rules;
(e)
animals are not in a fit state to continue their journey;
(f)
the veterinary certificate or document accompanying animals does not meet the conditions set pursuant to Community rules or, where rules have not been harmonized, the requirements provided for in the national rules corresponding to the various cases covered by this Directive.
The detailed rules for applying this Article shall be adopted in accordance with the procedure laid down in Article 23.
Article 6
1. Border inspection posts must satisfy the requirements of this Article.
2. Border inspection posts must be:
(a) located at the point of entry into one of the territories referred to in Annex I to Directive 90/675/EEC;
However, where necessitated by geographical constraints (such as unloading wharf, railway station, passes) and provided that in such a case the inspection post is located far from holdings or places where animals likely to be infected by contagious diseases are kept, siting of an inspection post at a certain distance from the point of entry may be tolerated;
(b)
located in a customs area enabling other administrative formalities to be carried out, including customs formalities relating to importation;
(c)
designated and approved in accordance with paragraph 3;
(d)
placed under the authority of an official veterinarian, who shall be effectively responsible for the checks. The official veterinarian may be assisted by specially trained auxiliary staff working under his direction.
3. Before 1 January 1992, and once border posts have been shortlisted by national authorities, acting in conjunction with the Commission departments which will verify their compliance with the minimum requirements set out in Annex A, Member States shall submit to the Commission the list of border inspection posts responsible for carrying out veterinary checks on animals, and shall provide the following information:
(a)
nature of the border inspection post:
- port,
- airport,
- road checkpoint,
- rail checkpoint;
(b)
nature of the animals which could be checked at the border inspection post in question given the equipment and veterinary staff available, indicating any animals that cannot be checked at those border inspection posts and for registered equidae the operating hours of a specially approved border inspection post;
(c)
staff assigned to veterinary checks:
- number of official veterinarians with at least one official veterinarian on duty at all times that the border inspection post is open,
- number of specially qualified auxiliary staff or assistants;
(d)
description of the equipment and premises available for carrying out:
- the documentary check,
- the physical check,
- sampling,
- the general tests laid down in Article 4 (2) (b),
- the specific tests ordered by the official veterinarian;
(e)
capacity of the premises available to house animals where necessary pending the test results;
(f)
nature of the equipment allowing a rapid exchange of information, particularly with other border inspection posts;
(g)
volume of trade (types and quantities of animals passing through this border inspection post).
4. Acting in conjunction with the competent national authorities, the Commission shall inspect the border inspection posts designated in accordance with paragraph 3 in order to satisfy itself that there is uniform application of the rules on veterinary checks and that the various border inspection posts in fact possess the necessary infrastructures and meet the minimum requirements laid down in Annex A.
Before 1 January 1992, the Commission shall submit to the Standing Veterinary Committee a report on the outcome of the inspection referred to in the first subparagraph, together with proposals taking into account the conclusions of the report, with a view to establishing a Community list of border inspection posts. That list shall be approved and subsequently updated in accordance with the procedure laid down in Article 22.
The abovementioned report shall cover any problems that would be encountered by certain Member States if the shortlisting referred to in the first subparagraph of paragraph 3 were to result in a large number of border inspection posts being excluded at 1 July 1992.
To take account of any such problem, some of the border inspection posts may be kept in operation and granted a maximum of three years to comply with the requirements of this Directive as regards equipment and structures.
The Commission shall publish the list of approved border inspection posts, and any subsequent updates, in the Official Journal of the European Communities.
5. As the need arises, the Commission shall adopt any detailed rules required for implementing this Article in accordance with the procedure laid down in Article 23.
Article 7
1. Where animals of species for which import rules have been harmonized at Community level are not to be placed on the market in the territory of the Member State which carried out the checks referred to in Article 4, the official veterinarian of the border inspection post shall, without prejudice to the specific requirements applicable to equidae registered and accompanied by the identification document provided for by Directive 90/427/EEC (8):
- provide the person concerned with a copy or, if the consignment of animals is split, several individually authenticated copies of the original certificates relating to the animals; the period of validity of such copies shall be no more than 10 days,
- issue a certificate which matches the model to be drawn up by the Commission in accordance with the procedure laid down in Article 23 attesting that the checks referred to in Articles 4 (1) and (2) (a), (b) and (d) have been carried out to the satisfaction of the official veterinarian, and specifying the nature of the samples that have been taken and the results of any laboratory tests, or when those results are expected,
- keep the original certificate or certificates accompanying the animals.
2. Detailed rules for the application of paragraph 1 shall be adopted in accordance with the procedure laid down in Article 23.
3. Once animals have passed through border inspection posts trade in the animals referred to in paragraph 1 and allowed into the territories referred to in Annex I to Directive 90/675/EEC shall be conducted in accordance with the rules for veterinary checks laid down in Directive 90/425/EEC.
In particular, the information from the competent authority of the place of destination given by means of the information exchange system provided for in Article 20 of Directive 90/425/EEC, must specify whether:
- animals are intended for a Member State or an area having specific requirements,
- samples have been taken but the results are not known when the means of transport leaves the border inspection post.
Article 8
A. Member States shall ensure that:
1. veterinary checks on imports of animals of species not covered by Annex A to Directive 90/425/EEC are carried out in accordance with the following provisions:
(a) where animals are presented directly at one of the border posts of the Member State which intends to import them, they shall undergo at that post all the checks provided for in Article 4;
(b)
where animals are presented at a border inspection post situated in another Member State, with the latter's prior agreement:
(i) either all the checks referred to in Article 4 shall be carried out at that post on behalf of the Member State of destination in order, in particular, to ensure that the latter's animal health requirements have been complied with;
(ii)
or, in the event of agreement between the competent central authorities of the two Member States and, where appropriate, those of the Member State or Member States of transit, only the checks provided for in Article 4 (1) shall be carried out at that post, in which case the checks provided for in Article 4 (2) shall be carried out in the Member State of destination.
In the latter case, however, animals may leave the border inspection post where the documentary check and identity check have been carried out only in sealed vehicles and only after the official veterinarian:
- has indicated on the copy, or, where the consignment is split, on the copies, of the original certificates that the animals have passed through and that the check has been carried out,
- has informed, by means of the information exchange system provided for in Article 20 of Directive 90/425/EEC, the veterinary authority of the place of destination or, where appropriate, of the Member State or Member States of transit, that the animals have passed through,
- notwithstanding Article 3 (1) (c), has given
a discharge to the competent customs authority of the border inspection post in respect of the animals presented.
In the case of animals intended for slaughter, Member States may have recourse only to the solution set out in (i).
Member States shall inform the Commission and the representatives of the other Member States meeting in the Standing Veterinary Committee, of cases of recourse to the solution set out in (ii);
2. pending adoption of the specific decisions provided for under Community rules, animals the trade in which has been harmonized at Community level but which come from a third country for which uniform animal health conditions have not yet been established shall be imported subject to the following conditions:
- they must have remained in the third country of dispatch at least during the periods provided
for in Article 10 (1) of Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine, fresh meat or meat products from third countries (9),
- they must undergo the checks provided for in Article 4,
- they may not leave the border inspection post or the quarantine centre unless such checks show that the animal or consignment of animals:
i(i) either, without prejudice to specific requirements applicable to the third countries concerned in respect of diseases foreign to the Community, complies with the animal health requirements applicable in trade in the species concerned as laid down in the Directives referred to in
Annex A to Directive 90/425/EEC or with the animal health requirements laid down in Directive 72/462/EEC;
(ii) or, in respect of one or more specific diseases, fulfils the conditions of equivalence recognized, in accordance with the procedure laid down in Article 23, on the basis of reciprocity, between the requirements of the third country and those of the Community;
- if they are intended for a Member State benefiting from the additional guarantees
provided for in Article 3 (1) (e) (iii) and (iv) of
Directive 90/425/EEC, they must satisfy the relevant requirements laid down in respect of intra-Community trade.
- after they have passed through the border inspection post, they must, in the case of animals for slaughter, be conveyed to the slaughterhouse of destination, or, in the case of animals for breeding and production or aquaculture animals, be conveyed to the holding of destination;
3. if the checks provided for in points 1 and 2 show that the animal or the consignment of animals does not comply with the requirements laid down therein, the animal or consignment may not leave the border inspection post or quarantine centre and
Article 12
shall be applicable;
4.
where the animals referred to in point 1 are not intended to be placed on the market in the territory of the Member State which has carried out the veterinary checks, the provisions of Article 7, and in particular those relating to the issue of the certificate, shall apply;
5.
at the place of destination, animals for breeding and prodution shall remain under the official supervision of the competent veterinary authorities. After an observation period to be determined in accordance with the procedure laid down in Article 23, the animals may enter intra-Community trade under the conditions laid down in Directive 90/425/EEC.
Animals for slaughter shall be subject, in the slaughterhouse of destination, to the Community rules relating to the slaughter of the species concerned.
B. Detailed rules for the application of this Article shall be adopted, as the need arises, in accordance with the procedure laid down in Article 23.
Article 9
1. Member States shall authorize the transit of animals from one third country to another third country provided that:
(a) such transit has been previously authorized by the official veterinarian of the border inspection post of the Member State in the territory of which the animals must be presented in order to undergo there the checks provided for in Article 4 and, where appropriate, by the competent central authority of the Member State or Member States of transit;
(b) the party concerned supplies proof that the first third country to which the animals are being sent, after transit through one of the territories referred to in Annex I
to Directive 90/675/EEC, undertakes under no circumstances to reject or to send back the animals, the
importation or transit of which it has authorized and undertakes to comply, in the territories referred to in Annex I to Directive 90/675/EEC, with Community rules on protection during transport;
(c) the check referred to in Article 4 shows to the satisfaction of the veterinarian, if applicable after the animals have passed through a quarantine centre, that the animals fulfil the requirements of this Directive or, in the case of animals referred to in Annex A to Directive 90/425/EEC, afford health guarantees recognized in accordance with the procedure laid down in Article 23 as being at least equivalent to those requirements;
(d) the competent authority of the border inspection post notifies the fact that the animals have passed through to the competent authorities of the Member State or Member Statess of transit and of the border post of exit, by means of the information exchange system referred to in the second subparagraph of Article 12 (4);
(e) in the case of passage through one of the territories referred to in Annex I to Directive 90/675/EEC, such transit is carried out under the Community transit procedure (external transit) or under any other customs transit procedure provided for in Community rules; the only handling authorized during transit shall be that carried out at the point of entry into or exit from one of the territories referred to in Annex I and operations to ensure the animals' welfare.
2. All expenditure incurred pursuant to this Article shall be chargeable to the consignor, the consignee or their representative without compensation by the Member State.
Article 10
1. In cases where Community rules or the national rules of the place of destination, in areas which have not been harmonized and in compliance with the general rules of the Treaty, provide for live animals to be placed in quarantine or isolation, such quarantine or isolation may take place:
- for disease other than foot-and-mouth disease, rabies and Newcastle disease, at a quarantine centre situated in the third country of origin, provided that it has been approved by the procedure laid down in Article 22 and is regularly inspected by the Commission's veterinary experts,
- at a quarantine centre situated within Community territory which meets the requirements laid down in Annex B,
- on the holding of destination.
Special safeguards to be complied with during transport between the quarantine centre farms of origin and of destination and border inspection posts and in the quarantine centres referred to in the first indent of the preceding subparagraph may be laid down in accordance with the procedure provided for in Article 23.
2. If the official veterinarian responsible for the border inspection post orders placing in quarantine, that quarantine must take place, depending on the hazard diagnosed by the official veterinarian:
- either at the border inspection post itself or in its immediate vicinity,
- or on the holding of destination,
- or at a quarantine centre situated in the vicinity of the holding of destination.
3. The general conditions to be fulfilled for the quarantine centres referred to in the first and second indents of paragraph 1 are laid down in Annex B.
The special approval conditions applicable to the different animal species shall be adopted in accordance with the procedure laid down in Article 23.
4. The procedure laid down in Article 22 must be followed for the approval and subsequent updating of the list of quarantine centres referred to in the first and second indents of paragraph 1 and the first indent of paragraph 2. Quarantine centres shall be subject to the inspection provided for in Article 19.
The Commission shall publish the list of quarantine centres and any subsequent updates in the Official Journal of the European Communities.
5. The second subparagraph of paragraph 1 and
paragraphs 3 and 4 shall not apply to quarantine
centres which are solely for the animals referred to in
Article 8
(A) (1).
6. All expenditure incurred pursuant to this Article shall be chargeable to the consignor, the consignee or their representative without compensation by the Member State.
7. Before 1 January 1996, the Commission shall submit to the Council a report, possibly accompanied by proposals, on the need for Community quarantine centres and financial assistance from the Community for their operation.
Article 11
1. Without prejudice to the remaining provisions of this Chapter, the official veterinarian or the competent authority shall, where it is suspected that veterinary legislation has not been complied with or there is doubt as to the identity of an animal, carry out any veterinary checks he or it deems appropriate.
2. Member States shall take the appropriate administrative or penal measures to penalize any infringement of veterinary legislation by natural or legal persons where it is found that Community rules have been infringed, in particular where it is found that the certificates or documents drawn up do not correspond to the actual state of the animals, that identification marks do not comply with
those rules or that the animals were not presented for inspection at a border post or that the animals have not been sent to the destination originally intended.
Article 12
1. Where the checks referred to in this Directive show that an animal does not satisfy the requirements laid down in Community rules or, on matters not yet harmonized, in national rules, or where such checks reveal an irregularity, the competent authority, after consultation with the importer or his representative, shall decide either:
(a) to shelter, feed and water and, if necessary, treat the animals; or
(b)
as the case may be, to place them in quarantine or to isolate the consignment;
(c)
to re-dispatch, within a time limit to be set by the competent national authority, the consignment of animals outside the territories referred to in Annex I to Directive 90/675/EEC where animal health or animal welfare requirements so allow.
In this case, the official veterinarian of the border inspection post must:
- inform the other border inspection posts, in accordance with paragraph 4, that the consignment has been rejected, indicating the infringements observed,
- under arrangements to be defined in accordance with the procedure laid down in Article 23, cancel the veterinary certificate or document accompanying the rejected consignment,
- at intervals to be determined, inform the Commission, via the competent central authority, as to the nature and frequency of the infringements observed.
If re-dispatch is impossible, in particular for reasons of the welfare of the animals, the official veterinarian:
- may, after agreement by the competent authority and after ante-mortem inspection, authorize slaughter of the animals for human consumption under the condition laid down by Community rules,
-
must, otherwise, order slaughter of the animals for purposes other than human consumption or order deduction of the carcases, specifying the conditions regarding control of the use of the products obtained.
The competent central authority shall inform the Commission of cases where recourse is had to these derogations in accordance with paragraph 4.
The Commission shall keep the Standing Veterinary Committee regularly informed of such cases.
2. The importer or his representative shall be liable for the costs incurred in the measures provided for in paragraph 1, the process of destroying the consignment or using the meat for other purposes.
The yield of the sale of the products referred to in the third subparagraph of paragraph 1 (c) must revert to the owner of the animals or his representative, after deduction of the above costs.
3. Detailed rules for the application of this Article shall be adopted, as the need arises, in accordance with theprocedure laid down in Article 23.
4. The competent authorities of the Member States, the border inspection posts and the Commission will be informed in the context of the programme for developing the computerization of procedures for veterinary checks.
To that end, the Commission, acting in accordance with the procedure provided for in Article 23, will introduce a computerized data-processing system linking the border inspection services and the competent veterinary authorities at the Commission, and including all data on imports of animals from third countries (Shift project), which will be linked to the system for exchanges of information between veterinary authorities provided for in Article 20 of Directive 90/425/EEC.
5. The competent authorities shall, where appropriate, communicate any information at their disposal in accordance with Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (10).
Article 13
In accordance with the procedure laid down in Article 23, the Commission shall, on the basis of the plans referred to in the second subparagraph, adopt the rules applicable to imports of animals for slaughter intended for local consumption and of breeding or production animals in certain parts of the territories referred to in Annex I to Directive 90/675/EEC to take account of the natural constraints specific to these territories, including their remoteness from the mainland part of Community territory.
To that end, by 31 December 1991 at the latest, Member States shall submit a plan to the Commission setting out the procedures for carrying out checks on imports, into the regions referred to in the first subparagraph, of animals from third countries. These plans must specify the checks carried out to prevent animals introduced into the territories
concerned or products obtained from those animals being dispatched under any circumstances to other parts of Community territory.
Article 14
For the purposes of carrying out the checks referred to in
Article 7
(3) of this Directive, the identification and registration provided for in Article 3 (1) (c) of Directive 90/425/EEC must, except in the case of animals for slaughter and registered equidae, be carried out at the place of destination of the animals, where appropriate after the observation period provided for in Article 8A (5) of this Directive.
The procedures for identifying or marking animals for slaughter shall be determined according to the procedure provided for in Article 23.
Article 15
1. Member States shall collect a health fee when the animals referred to in this Directive are imported to cover the costs occasioned by health inspections and checks, as provided for in Articles 4, 5, and 8.
2. The Council, acting by a qualified majority on a proposal from the Commission shall, before 1 July 1992, take a decision on the level or levels of the fees referred to in paragraph 1 and on the detailed rules and principles for the implementation of this Directive, and on possible exceptions.
Article 16
Under the procedure provided for in Article 23 and on a reciprocal basis, less frequent identity checks and/or physical checks may, without prejudice to controls to see that the welfare requirements during transport are being complied with, be applied under certain conditions, and in particular in the light of the results of checks carried out prior to the adoption of this Directive.
The Commission shall take into account the following criteria for granting derogations of this nature:
(a) the guarantees offered by the third country in question with respect to compliance with Community requirements, particularly those of Directives 72/462/EEC and 90/426/EEC;
(b)
the health situation of animals in the third country concerned;
(c)
information on the health situation in the third country;
(d)
nature of the measures to monitor and to combat disease applied by the third country;
(e)
structures and powers of the veterinary service;
(f)
rules on the authorization of certain substances and compliance with the requirements set out in Article 7 of
Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues (11);
(g)
outcome of the Community inspection visits;
(h)
outcome of the import controls carried out.
Article 17
Rights of appeal existing under the laws in force in the Member States against decisions by the competent authorities shall not be affected by this Directive.
Decisions taken by the competent authority of the Member State of destination and the reasons for such decision shall be notified to the importer concerned by such decisions or his representative.
If the importer concerned or his representative so requests, the said decisions and reasons shall be forwarded to him in writing with details of the rights of appeal which are available to him under the law in force in the Member State in which the frontier inspection post is situated, and of the procedure and time limits applicable.
CHAPTER II Safeguard provisions
Article 18
1. If a disease referred to in Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community ($), a zoonosis or other disease or phenomenon liable to present a serious threat to animal or human health occurs or spreads in the territory of a third country, or if any other serious animal health reason so warrants, in particular in the light of the findings of its veterinary experts, the Commission may, acting on its own initiative or at the request of a Member State, adopt one of the following measures without delay and depending on the gravity of the situation:
- suspend imports coming from all or part of the third country concerned, and where appropriate from the third country of transit,
- set special conditions in respect of animals coming from all or part of the third country concerned.
2. If one of the checks provided for in this Directive indicates that a consignment of animals is likely to
(;) OJ No L 275, 26. 9. 1986, p. 36.
($) OJ No L 378, 31. 12. 1982, p. 58. Directive as last amended by Decision 90/134/EEC (OJ No L 76, 22. 3. 1990, p. 23).
constitute a danger for animal or human health, the competent veterinary authority shall immediately take the following measures:
- it shall seize and destroy the consignment,
- it shall immediately inform the other border inspection posts and the Commission of the findings and of the
origin of the animals, in accordance with Article 12 (4).
3. In the case provided for in paragraph 1, the Commission may take interim protective measures in respect of animals covered by Article 9.
4. Representatives of the Commission may make an immediate visit to the third country concerned.
5. In the case where a Member State informs the Commission officially of the need to take safeguard measures and the Commission has not invoked paragraphs 1 and 3 or made a referral to the Standing Veterinary Committee in accordance with paragraph 6, that Member State may take interim protective measures in respect of the animals in question.
Where a Member State takes interim protective measures in respect of a third country under the terms of this paragraph, it shall inform the other Member States and the Commission in accordance with Article 12 (5).
6. Within 10 working days, the Standing Veterinary Committee shall have the matter referred to it, pursuant to the terms of Article 22, with a view to the extension, amendment or repeal of the measures provided for in paragraphs 1, 3 and 5.
7. Decisions to extend, amend or repeal measures decided on pursuant to paragraphs 1, 2, 3 and 6 shall be taken in accordance with the procedure laid down in Article 22.
8. Detailed rules for the application of this Chapter shall be adopted, where the need arises, in accordance with the procedure laid down in Article 23.
CHAPTER III Inspection
Article 19
1. Veterinary experts from the Commission may, in conjunction with the competent national authorities and to the extent necessary for uniform application of the requirements of this Directive, verify that the border inspection posts approved in accordance with Article 6 and the quarantine centres approved in accordance with Article 10 satisfy the criteria listed respectively in Annexes A and B.
2. Veterinary experts from the Commission may, in conjunction with the competent authorities, make on-the-spot checks.
3. A Member State in whose territory an inspection is made shall provide the veterinary experts from the Commission with any assistance they may require in the performance of their tasks.
4. The Commission shall inform the Member States of the outcome of the checks.
5. Where the Commission deems that the outcome of checks so justifies, it shall review the situation within the Standing Veterinary Committee. It may adopt the necessary decisions in accordance with the procedure laid down in Article 22.
6. The Commission shall monitor developments; in the light of such developments and in accordance with the procedure laid down in Article 22, it may amend or repeal the decisions referred to in paragraph 5.
7. Detailed rules for the application of this Article shall be adopted, where the need arises, in accordance with the procedure laid down in Article 23.
Article 20
Where, on the basis of the checks carried out at the point where the animals are marketed, a competent authority of a Member State considers that this Directive is not being complied with at a border inspection post of another Member State, it shall contact the competent national authority of that Member State without delay.
The latter shall take all the necessary measures and inform the competent authority of the first Member State of the nature of the checks made, the decision taken and the reasons for such decisions.
If the competent authority of the first Member State believes the measures are insufficient it shall examine, with the competent authority of the Member State in question, the ways and means in which the situation could be remedied, where necessary by visiting the Member State in question.
Where the checks referred to in the first subparagraph show repeated non-compliance with this Directive, the competent authority of the Member State of destination shall inform the Commission and the competent authorities of the other Member States.
The Commission must, at the request of the competent authority of the Member State of destination or on its own initiative, send an inspection team to the Member State in question in conjunction with the competent national authorities. Depending on the type of infringement observed, that team may remain in the Member State in question until the decisions referred to in the final subparagraph have been taken.
Pending the Commission's findings, the Member State in question must, at the request of the Member State of destination, step up checks at the border inspection post or quarantine centre concerned.
The Member State of destination may, for its part, intensify checks on animals coming from these sources.
At the request of one of the two Member States concerned, and in accordance with the procedure laid down in Article 22, the Commission must, where the irregularities are confirmed by the inspection referred to in the fifth subparagraph, take the appropriate measures. These measures must be confirmed or reviewed as soon as possible in accordance with the same procedure.
Article 21
1. Each Member State shall draw up a programme for the exchange of staff designated to carry out the veterinary checks on animals coming from third countries.
2. The Commission and the Member States shall coordinate the programmes referred to in paragraph 1 within the Standing Veterinary Committee.
3. Member States shall take all the measures necessary to allow implementation of the programmes resulting from the coordination referred to in paragraph 2.
4. Each year, in the Standing Veterinary Committee, the implementation of programmes shall be reviewed on the basis of reports drawn up by the Member States.
5. Member States shall take into account the experience gained, in order to improve and develop the exchange programmes.
6. A financial contribution from the Community may be granted in order to promote the efficient development of exchange programmes. Detailed rules for such contribution and the estimated amount to be charged to the general budget of the European Communities are laid down in Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (12).
7. Detailed rules for the application of paragraphs 1, 4 and 5 shall be adopted, where the need arises, in accordance with the procedure laid down in Article 23.
CHAPTER IV General provisions
Article 22
Where reference is made to the procedure provided for in this Article, action shall be taken in accordance with Article 17 of Directive 89/662/EEC.
(;) OJ No L 224, 18. 8. 1990, p. 19. Decision amended by Decision 91/133/EEC (OJ No L 66, 13. 3. 1991, p. 18).
Article 23
Where reference is made to the procedure provided for in this Article, action shall be taken in accordance with Article 18 of Directive 89/662/EEC.
Article 24
The Annexes to this Directive shall, where the need arises, be amended in accordance with the procedure laid down in Article 23.
Article 25
This Directive shall be without prejudice to obligations arising from customs rules.
Article 26
1. Articles 12 and 28 of Directive 72/462/EEC shall be deleted.
Pending the decisions provided for in Articles 5 and 6 of this Directive, the acts adopted pursuant to Article 12 of Directive 72/462/EEC shall continue to apply.
2. Articles 20 and 21 of Directive 90/426/EEC and
Articles 27 and 29 (2) of Directive 90/539/EEC shall be deleted.
Article 27
1. Directive 89/662/EEC is hereby amended as follows:
(a) in article 19 (2) '31 December 1992' shall be replaced by '31 December 1996';
(b) Article 22 shall be replaced by the following:
'Article 22
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 July 1992.'
2. Directive 90/425/EEC shall be amended as follows:
(a) Article 7 shall be replaced by the following:
'Article 7
1. Member States shall ensure that, during checks carried out at the places where animals and products referred to in Annex I from a third country may be brought into the territories defined in Annex I to Directive 90/675/EEC, such as ports, airports and border inspection posts with third countries, the following measures are taken:
(a) certificates or documents accompanying the animals and products are checked;
(b)
Community animals and products shall be subject to the control rules laid down in Article 5;
(c)
products from third countries shall be subject to the rules laid down in Directive 90/675/EEC;
(d)
animals from third countries shall be subject to the rules laid down in Directive 91/496/EEC.
2. However, as from 1 January 1993 and by way of derogation from paragraph 1, all animals or products transported by means of transport providing a regular and direct link between two geographical points of the Community shall be subject to the rules for control provided for in Article 5.'
(b)
Article 23
shall be replaced by the following:
'Article 23
The Council shall, on the basis of a Commission report, accompanied by possible proposals on which the Council will decide by a qualified majority, re-examine:
- the provisions of Article 10 and of Article 5 (2) (a) before 1 January 1993,
- other provisions before 1 January 1996.'
(c)
In Article 26:
in the first subparagraph, point (ii) shall be replaced by:
'(ii) the other provisions of this Directive on 1 July 1992.';
the second subparagraph shall be deleted.
3. Directive 90/675/CEE is hereby amended as follows:
(a) in Article 19, paragraph 6 shall be replaced by the following:
'6. Within 10 working days, the Standing Veterinary Committee shall have the matter referred to it, pursuant to the terms of Article 23, with a view to the extension, amendment or repeal of the measures provided for in paragraphs 1, 3 and 5. The procedure provided for in Article 23 may also be used to adopt the necessary decisions, including those relating to intra-Community movement of products and to transit.
(b) In Article 32, 'by 31 December 1991' shall be replaced by 'on 1 July 1992'.
Article 28
Acting in accordance with the procedure laid down in
Article 23, the Commission may adopt for three years the transitional measures necessary to facilitate the transition to the new checking arrangements provided for in this Directive.
Article 29
Member States may make use of the Community financial assistance provided for in Article 38 of Directive 90/424/EEC for the implementation of this Directive, in particular for setting up networks for exchanges of information between veterinary services and border posts.
Article 30
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with:
(a) the provisions of Article 6 (3) and Articles 13, 18 and 21 on 1 December 1991;
(b) the other provisions of this Directive on 1 July 1992.
They shall forthwith inform the Commission thereof.
When these measures are adopted by the Member States, they shall contain a reference to this Directive or shall be
accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Detailed rules for applying this Directive, and in particular those concerning Article 8 (3), shall be adopted and the system referred to in the second subparagraph of Article 12 (4) brought into force on 1 July 1992.
If the date referred to in the preceding subparagraph cannot be met, the transitional measures provided for in Article 28 shall be taken on that date.
Article 31
This Directive is addressed to the Member States. | [
"UKSI19923295",
"UKSI19970639"
] |
31991L0492 | 1991 | Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas, with a view to achieving the internal market and more especially to ensure the smooth operation of the common organization of the market in fishery products established by Regulation (EEC) No 3796/81 (4) as last amended by Regulation (EEC) No 2886/89 (5), it is essential that the placing on the market of live bivalve molluscs should no longer be hindered by disparities existing in the Member States in respect of health requirements; whereas this will enable production and placing on the market to be better harmonized and bring about competition on equal terms while ensuring quality products for the consumer.
Whereas Council Directive 79/923/EEC of 30 October 1979 on the quality required of shellfish waters (6) lays down that it is necessary to establish the health requirements to be observed for shellfish products;
Whereas these requirements should be laid down for all stages during harvesting, handling, storage, transport and distribution of live bivalve molluscs in order to safeguard the public health of consumers; whereas these requirements shall apply equally to echinoderms, tunicates and marine gastropods;
Whereas it is important, should a health problem occur after the placing on the market of live bivalve molluscs to be able to trace back the establishment of dispatch and the harvesting area of origin; whereas it is therefore necessary to introduce a registration and labelling system which will enable the route of a batch after harvesting to be followed;
Whereas it is important that the public health standards for the final product must be specified; whereas, however, scientific and technological knowledge is not always advanced enough to lay down definitive solutions for certain health problems and whereas it is therefore necessary, in order to guarantee optimal protection of public health, to set up a Community system to ensure rapid adoption and where necessary reinforcement of the health standards to safeguard human health from virus contamination or other hazards;
Whereas live bivalve molluscs obtained from harvesting areas which do not permit direct, safe consumption may be rendered safe by submitting them to a purification process or by relaying in clean water over a relatively long period; whereas it is therefore necessary to define production areas from which molluscs can bet gathered for direct human consumption, or from which they have to be purified or relayed;
Whereas it is primarily the responsibility of the producers to ensure that the bivalve molluscs are produced and placed on the market in compliance with the health requirements prescribed; whereas the competent authorities must, by carrying out checks and inspections, ensure that producers comply with those requirements; whereas the competent authorities must in particular submit harvesting areas to a regular control to ensure that molluscs from these harvesting areas do not contain microorganisms and toxic substances in quantities which are considered to be dangerous to human health;
Whereas control measures organized on a Community level must be introduced to guarantee the uniform application in all Member States of the standards laid down in this Directive;
Whereas the rules, principles and safeguard measures established by Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (7), should apply to the case in question;
Whereas in the context of trade between the Member States, the rules laid down in Council Directive 89/662/EEC of
11 December 1989 concerning veterinary checks in intra-Community trade, with a view to the completion of the internal market (8) as amended by Directive 90/675/EEC should also be applied;
Whereas live bivalve molluscs produced in a third country and intended to be placed on the market in the Community must not qualify for more favourable conditions than those applied in the Community; whereas provision must be made for a Community procedure for checking the conditions in third countries of production and of the placing on the market, in order to allow the Community to apply a common import system based on conditions of equivalence;
Whereas, so that account may be taken of particular circumstances, derogations should be granted to certain establishments already operating before 1 January 1993 so as to allow them to adapt to all the requirements laid down in this Directive;
Whereas, in the case of living animals that are edible whilst they are alive, a derogation should be made, with regard to the durability date, to the rules of Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale (9) as last amended by Directive 91/72/EEC (10);
Whereas provision should be made for the possibility of adopting transitional measures in order to cover the absence of certain implementing rules;
Whereas the Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas to that end, procedures should be laid down introducing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee,
CHAPTER I General provisions
Article 1
This Directive lays down health conditions for the production and placing on the market of live bivalve molluscs which are intended for immediate human consumption or for further processing before consumption.
With the exception of the provisions on purification, this Directive applies to echinoderms, tunicates and marine gastropods.
Article 2
For the purposes of this Directive, the following definitions shall apply:
1. 'bivalve molluscs' means filter-feeding lamellibranch molluscs;
2. 'marine biotoxins' means poisonous substances accumulated by bivalve molluscs feeding on plankton containing toxin;
3. 'clean sea water' means sea water or brackish water which is to be used under the conditions laid down in this Directive and which is free from microbiological contamination and toxic and objectionable substances occurring naturally or after discharge in the environment such as those listed in the Annex to Directive 79/923/EEC, in such quantities as may adversely affect the health quality of bivalve molluscs or to impair their taste;
4. 'competent authority' means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence;
5. 'conditioning' means the storage of live bivalve molluscs, whose quality does not indicate the need for relaying or treatment in a purification plant, in tanks or any other installation containing clean sea water or in natural sites to remove sand, mud or slime;
6. 'gatherer' means any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market;
7. 'production area' means any sea, estuarine or lagoon area containing natural deposits of bivalve molluscs or sites used for cultivation of bivalve molluscs from which live bivalve molluscs are taken;
8. 'relaying area' means any sea, estuarine or lagoon area approved by the competent authority, with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs;
9. 'dispatch centre' means any approved on-shore or off-shore installation for the reception, conditioning, washing, cleaning, grading and wrapping of live bivalve molluscs fit for human consumption;
10. 'purification centre' means an approved establishment with tanks fed by naturally clean sea water or sea water that has been cleaned by appropriate treatment, in which live bivalve molluscs are placed for the time necessary to remove microbiological contamination, so making them fit for human consumption;
11. 'relaying' means an operation whereby live bivalve molluscs are transferred to approved sea or lagoon areas or approved estuarine areas under the supervision of the competent authority for the time necessary to remove contamination. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening;
12. 'means of transport' means those parts set aside for goods in automobile vehicles, rail vehicles and aircraft, the holds of vessels and containers for transport by land, sea or air;
13. 'wrapping' means an operation whereby live bivalve molluscs are placed in packaging material adequate for the purpose;
14. 'consignment' means a quantity of live bivalve molluscs handled in a dispatch centre or treated in a purification centre and subsequently intended for one or more customers;
15. 'batch' means a quantity of live bivalve molluscs collected from a production area and subsequently intended for delivery to an approved dispatch centre, purification centre, relaying area or processing plant as appropriate;
16. 'placing on the market' means the holding or displaying for sale, offering for sale, selling, delivering or any other form of placing on the market of live bivalve molluscs for human consumption either raw or for the purpose of processing in the Community, excluding the direct transfer on the local market in small quantities by the coastal fisherman to the retailer or the consumer which must be subject to the health checks laid down by national rules for checking on retail business;
17. 'importation' means the introduction of live bivalve molluscs into the territory of the Community from third countries;
18. 'faecal coliform' means facultative, aerobic, gram-negative, non-sporeforming, cytochrome oxidase negative, rod-shaped bacteria that are able to ferment lactose with gas production in the presence of bile salts, or other surface active agents with similar growth-inhibiting properties, at 44 oC p 0,2 oC within 24 hours at least;
19. 'E. coli' means faecal coliforms which also form indole from tryptophan at 44 oC p 0,2 oC within 24 hours.
CHAPTER II Provisions for Community production
Article 3
1. The placing on the market of live bivalve molluscs for immediate human consumption shall be subject to the following conditions:
(a) they must originate from production areas which comply with the requirements laid down in Chapter I of the Annex; however, in the case of pectinidae, this provision shall apply only to aquaculture products as defined in Article 2 (2) of Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and placing on the market of fishery products (;);
(b) they must have been harvested and transported from the production area to a dispatch centre, purification centre, relaying area or processing plant under the conditions laid down in Chapter II of the Annex;
(c) where provided for in this Directive, they must have been relaid in suitable areas approved for that purpose and complying with the conditions laid down in Chapter III of the Annex;
(d) they must have been handled hygienically, and where appropriate, they must have been purified in establishments approved for that purpose and complying with the requirements of Chaper IV of the Annex;
(e) they must comply with the criteria set out in Chapter V of the Annex;
(f) health controls must have been carried out in accordance with Chapter VI of the Annex;
(g) they must have been appropriately wrapped in accordance with Chapter VII of the Annex;
(h) they must have been stored and transported under satisfactory conditions of hygiene in accordance with Chapters VIII and IX of the Annex;
(i) they must bear a health mark as provided for in Chapter X of the Annex.
2. Live bivalve molluscs intended for further processing must comply with the relevant requirements of paragraph 1 and be processed in accordance with the requirements of Council Directive 91/493/EEC.
Article 4
Member States shall ensure that persons handling live bivalve molluscs during their production and placing on the market shall adopt all measures necessary to comply with the requirements of this Directive.
Persons responsible for dispatch and purification centres shall in particular ensure that:
- representative numbers of samples for laboratory examination are regularly taken and analysed in order to establish an historical record on the basis of the areas where batches come from and of the health quality of the live bivalve molluscs both before and after handling at a dispatch centre or purification centre.
- a register is kept for the permanent record of the results of the various checks and kept for presentation to the competent authority.
Article 5
1. (a) The competent authority shall approve dispatch centres and purification centres once it is satisfied that they meet the requirements of this Directive. The competent authority shall take the necessary measures if the requirements cease to be met. In so doing, it shall take account of, in particular, the outcome of any check carried out in accordance with Article 6 (1).
However, subject to the express condition that live molluscs coming from such centres meet the hygiene standards set by this Directive, Member States may, for the requirements relating to equipment and structures laid down in Chapter IV of the Annex, to be specified before 1 October 1991 in accordance with the procedure laid down in Article 12, grant to dispatch and purification centres, a further period expiring on 31 December 1995 within which to comply with the conditions of the approval set out in the abovementioned Chapter. Such derogations may be granted only to establishments, already operating on 31 December 1991, which have, before 1 July 1992, submitted a duly substantiated application for derogation to the competent national authority. This application must be accompanied by a work plan and programme indicating the period within which it would be possible for the establishments to comply with the requirements in question. Where financial assistance is requested from the Community, only requests in respect of projects complying with the requirements of this Directive can be accepted.
The competent authority shall draw up a list of approved dispatch centres and purification centres, each of which shall have an official number.
The list of approved dispatch centres and purification centres, and any subsequent amendments thereto, must be communicated by each Member State to the Commission, which shall pass such information on to the other Member States.
(b) The inspection and monitoring of these centres shall be carried out regularly under the responsibility of the competent authority, which shall have free access to all parts of the centres, in order to ensure compliance with the provisions of this Directive.
If such inspections and monitoring reveal that the requirements of this Directive are not being met, the competent authority shall take appropriate action.
2. (a) The competent authority shall establish a list of production and relaying areas, with an indication of their location and boundaries, from which live bivalve molluscs may be taken in accordance with the requirements of this Directive and, in particular, with Chapter I of the Annex.
This list must be communicated to those affected by this Directive, such as gatherers and operators of purification centres and dispatch centres.
. (b) The monitoring of the production and relaying areas shall be carried out under the responsibility of the competent authority in accordance with the requirements of this Directive.
If such monitoring reveals that the requirements of this Directive are no longer being met, the competent authority shall close the production or relaying area concerned until the situation has been restored to normal.
3. The competent authority may prohibit any production and harvesting of bivalve molluscs in areas considered unsuitable for these activities for health reasons.
Article 6
1. Experts from the Commission may, in cooperation with the competent authorities of the Member States, make on-the-spot checks insofar as is necessary to ensure the uniform application of this Directive. They may, in particular, check whether centres, production and relaying areas are in effect complying with the requirements of this Directive. A Member State in whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the Member States of the results of such checks.
2. The arrangements for implementing paragraph 1 shall be adopted in accordance with the procedure laid down in Article 12.
3. The Commission, may draw up recommendations containing guidelines on good manufacturing practices applicable at the different stages of production and placing on the market.
Article 7
1. The rules laid down in Directive 89/662/EEC as regards live bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption, shall apply, in particular as regards the organization of and the action to be taken following the checks to be carried out by the Member State of destination, and the safeguard measures to be implemented.
2. Directive 89/662/EEC shall be amended as follows:
(a) In Annex A, the following indent shall be added:
'- Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and placing on the market of live bivalve molluscs, (OJ No L 268, 24. 9. 1991, p. 1.);
(b) in Annex B, the following indent shall be deleted:
'- live bivalve molluscs intended for human consumption'.
CHAPTER III Imports from third countries
Article 8
Provisions applied to imports of live bivalve molluscs from third countries shall be at least equivalent to those governing the production and placing on the market of Community products.
Article 9
In order to ensure the uniform application of the requirement imposed in Article 8, the following procedure shall apply:
1. inspections shall be carried out on the spot by experts from the Commission and the Member States to verify whether the conditions of production and placing on the market can be considered as being equivalent to those applied in the Community.
The experts from the Member States who are to be entrusted with these inspections shall be appointed by the Commission, acting on a proposal from the Member States.
These inspections shall be made on behalf of the Community, which shall bear the cost of any expenditure in this connection.
The frequency and the procedure for these inspections shall be determined in accordance with the procedure laid down in Article 12;
2. in deciding whether the conditions of production and placing on the market of live bivalve molluscs in a third country can be deemed equivalent to those of the Community, particular account shall be taken of:
(a) the legislation of the third country;
(b) the organization of the competent authority of the third country and of its inspection services, the powers of such services and the supervision to which they are subject, as well as their facilities for monitoring the implementation of their legislation in force;
(c) the actual health conditions during the production and placing on the market of live bivalve molluscs and in particular the monitoring of production areas in relation to microbiological and environmental contamination, and to the presence of marine biotoxins;
(d) the regularity and the rapidity of the information provided by the third country on the presence of plankton containing toxin in the production areas and, in particular, of species not occurring in Community waters, and risks that such presence may signify for the Community;
(e) the assurances which a third country can give on the compliance with the standards laid down in Chapter V of the Annex;
3. the Commission, following the procedure laid down in Article 12, shall decide on:
(a) the list of third countries fulfilling the conditions of equivalence referred to in paragraph 2;
(b) for each third country, the specific conditions for the importation of live bivalve molluscs. These conditions must include:
(i) the procedure for obtaining a health certificate which must accompany consignments when forwarded to the Community;
(ii) the demarcation of the production areas from which live bivalve molluscs may be harvested and imported;
(iii) the obligation to notify the Community of any possible change in the approval of production areas;
(iv) any purification after arrival in the territory of the Community;
(c) a list of establishments from which the importation of live bivalve molluscs is authorized. For that purpose, one or more lists of such establishments shall be established. An establishment may not appear on a list unless it is officially approved by the competent authority of the third country exporting to the Community. Such approval shall be subject to observance of the following requirements:
- compliance with requirements equivalent to those laid down in this Directive,
- monitoring by an official inspection service of the third country;
4. the decisions referred to in paragraph 3 may be amended in accordance with the procedure laid down in Article 12.
These decisions and the amendments thereto shall be published in the Official Journal of the European Communities, L series;
5. pending the decisions referred to in paragraph 3, the conditions which Member States shall apply to imports
of live bivalve molluscs from third countries shall be at least equivalent to those governing the production and placing on the market of Community products.
Article 10
The rules and principles laid down in Directive 90/675/EEC shall apply, with particular reference to the organization of and follow up to the inspections to be carried out by
the Member States and the safeguard measures to be
implemented.
Without prejudice to compliance with the rule and principles referred to in the first subparagraph of this Article and pending implementation of the decisions provided for in Article 8 (3) and Article 30 of Directive 90/675/EEC, the relevant national rules for applying Article 8 (1) and (2) of the said Directive shall continue to apply.
CHAPTER IV Final provisions
Article 11
The chapters of the Annex may be amended by the Council, acting by a qualified majority on a proposal from the Commission.
The Commission shall, before 1 January 1994, submit to the Council, after receiving the opinion of the Scientific Veterinary Committee, a report on Chapters I and V of the Annex, accompanied by any proposed amendments to those Chapters.
Article 12
1. Where the procedure laid down in this Article is to
be followed, the Chairman shall refer the matter to the
Standing Veterinary Committee hereafter referred to as the committee, either on his own initiative or at the request of a Member State.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
. (b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay,
submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority.
Article 13
In order to take into account the possible failure to take a decision on the detailed rules for applying this Directive by
1 January 1993, necessary transitional measures may be adopted in accordance with the procedure laid down in Article 12 for a period of two years.
Article 14
The Commission shall, after consulting the Member States, submit, before 1 July 1992, a report to the Council on the minimum requirements to be met with regard to structure and equipment by small dispatch centres or by small establishments ensuring distribution on the local market and situated in areas subject to particular constraints with respect to their supply, possibly accompanied by proposals, on which the Council will take a decision, acting in accordance with the voting procedure laid down in Article 43 of the Treaty, before 31 December 1992.
The provisions of this Directive shall be re-examined before 1 January 1998 by the Council, acting on a Commission proposal, in the light of the experience gained.
Article 15
The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall notify the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 16
This Directive is addressed to the Member States. | [
"UKSI19942782",
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] |
31991L0410 | 1991 | Commission Directive 91/410/EEC of 22 July 1991 adapting to technical progress for the fourteenth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Directive 79/831/EEC (2), and in particular Article 19 thereof;
Whereas, pursuant to Article 15 (2) of Directive 67/548/EEC, containers containing certain dangerous substances intended for domestic use must be fitted with child-resistant fastenings and/or carry a tactile warning of danger;
Whereas, pursuant to Article 6 (2) of Council Directive 88/379/EEC (3), containers containing certain categories of dangerous preparations offered or sold to the general public are to be fitted with child-resistant fastenings and/or carry a tactile warning of danger;
Whereas all forms of packages which are sufficiently safe for children, especially those defined by international standards, can be considered as packages fitted with childresistant fastenings;
Whereas the technical specifications relating to these provisions are set out in Annex IX, parts A and B of Directive 67/548/EEC ; whereas Article 19 of Directive 79/831/EEC provides that Annex IX arises from the procedure of the Committee for Adaptation to Technical Progress;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in dangerous Substances and Preparations,
Article 1
The text of Annex IX to Directive 67/548/EEC is replaced by the text appearing in the Annex to the present Directive.
Article 2
1. By 1 August 1992, Member States shall adopt and publish the provisions necessary to comply with this Directive and shall forthwith inform the Commission thereof. They shall apply these provisions from 1 November 1992 at the latest.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19943247"
] |
31991L0442 | 1991 | Commission Directive 91/442/EEC of 23 July 1991 on dangerous preparations the packaging of which must be fitted with child-resistant fastenings
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous dangerous (1), as last amended by Directive 90/492/EEC (2), and in particular Article 6 (3) thereof,
Whereas, pursuant to Article 6 (2) of Directive 88/379/EEC, containers containing certain categories of dangerous preparations offered or sold to the general public are to be fitted with child-resistant fastenings and/or carry a tactile warning of danger; whereas under Article 6 (3) the categories of dangerous preparations the packaging of which have to be fitted with the abovementioned devices are to be defined by the procedure referred to in Article 21 of Council Directive 67/548/EEC (3), as last amended by Directive 90/517/EEC (4);
Whereas Commission Directive 90/35/EEC (5) defines, in accordance with Article 6 of Directive 88/379/EEC, the categories of preparations the packaging of which are to be fitted with child-resistant fastenings;
Whereas certain preparations not falling within these categories of danger may nevertheless, due to their composition, present a danger for children; whereas such preparations should therefore be clearly identified by certain characteristics, and their packaging equipped with child-resistant fastenings;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in Dangerous Substances and Preparations,
Article 1
Containers, whatever their capacity, containing preparations offered or sold to the general public and having one of the characteristics listed in the Annex hereto shall be fitted with child-resistant fastenings. These fastenings must conform to the specifications in Part A of Annex IX to Directive 67/548/EEC.
Article 2
The provisions of Articles 1 and 2 of Directive 90/35/EEC and those of Article 1 of this Directive, with the exception of the preparations characterized in point (a) of the Annex, shall also apply to preparations offered or sold to the general public in the form of aerosols.
Article 3
If there is any doubt as regards compliance with the provisions of Directive 90/35/EEC or of this Directive, the authorities in the Member States responsible for monitoring the application of Directive 88/379/EEC may require the party responsible for placing such preparations on the market to provide them with any pertinent information, including the test certificate issued in accordance with Part A of Annex IX to Directive 67/548/EEC.
Article 4
Member States shall bring into force the provisions necessary to comply with this Directive by 1 August 1992 at the latest. They shall immediately inform the Commission thereof.
They shall apply these provisions from 1 November 1992 (three months after the date fixed in paragraph 1).
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States.
Article 5
This Directive is addressed to the Member States. | [
"UKSI19922620",
"UKSI19943247"
] |
31991L0497 | 1991 | Council Directive 91/497/EEC of 29 July 1991 amending and consolidating Directive 64/433/EEC on health problems affecting intra-Community trade in fresh meat to extend it to the production and marketing of fresh meat
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposals from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas meat from bovine animals, swine, sheep and goats and domestic solipeds is included in the list of products in Annex II to the Treaty; whereas production of and trade in fresh meat constitutes an important source of income for part of the farming population;
Whereas in order to ensure the rational development of this sector and to increase productivity, public health rules governing production and placing on the market must be laid down at Community level;
Whereas the Community has to adopt measures for the gradual establishment of the internal market over a period expiring on 31 December 1992;
Whereas Directive 64/433/EEC (4) laid down the health requirements to be complied with in intra-Community trade in meat from bovine animals, swine, sheep and goats and domestic solipeds;
Whereas Directive 89/662/EEC (5) laid down rules on the checks to be applied with a view to the completion of the internal market, and in particular abolished veterinary checks at frontiers between Member States;
Whereas to take account of the abolition of the said checks and of the introduction of more stringent guarantees at origin when it is no longer possible to distinguish between products for the domestic market and products to be marketed in another Member State, the requirements of Directive 64/433/EEC should be adapted and extended to all meat production;
Whereas to that end it is necessary to harmonize the conditions under which certain meat is declared unfit for human consumption;
Whereas Directive 64/433/EEC has been substantially amended on a number of occasions; whereas for the sake of clarity that Directive should be consolidated;
Whereas it is necessary to adapt the references in Council Directive 72/462/EEC of 12 December 1972, on health and veterinary inspection problems upon importation of bovine animals and swine and ovine and caprine animals and fresh meat or meat products from third countries (6), in the light of that consolidation,
Article 1
Directive 64/433/EEC is hereby replaced by the text annexed to this Directive.
Article 2
Directive 72/462/EEC is hereby amended as follows:
1) in the third indent of Article 1 (1), the text in brackets shall be replaced by the following:
'(including the species Bubalus bubalis and Bison bison)';
2) In Article 4 (c):
(a) in the second subparagraph
- '13' shall be replaced by '14',
- '24' shall be deleted,
- '41 (C)' shall be replaced by '42 (A) (2)';
(b)
the following subparagraph shall be added:
'In accordance with the same procedure, specific guarantees may be required concerning the quality of the potable water used by establishments and the medical supervision of staff working on and handling fresh meat.';
3) In Article 17:
(a)
paragraph 2:
- in (b) 'Chapter V' shall be replaced by
'Chapter VI',
- in (c) 'Chapter VI' shall be replaced by 'Chapter VII',
- in (d) 'Chapter VII' shall be replaced by 'Chapter VIII',
- in (e) 'Chapter X' shall be replaced by 'Chapter XI' and 'Chapter XIII' shall be replaced by 'Chapter XIV',
- in (g) 'Chapter XIV' shall be replaced by 'Chapter XV'.
(b)
paragraph 3:
- 'Chapter XIII' shall be replaced by 'Chapter XIV';
4) In Article 18:
(a)
paragraph 1 (b):
(i) 'Chapter VIII' shall be replaced by 'Chapter IX';
(ii)
'Chapter IX' shall be replaced by 'Chapter X';
(iii)
'Chapter XI' shall be replaced by 'Chapter XII';
(b)
paragraph 3:
- 'paragraph 45 (d) of Chapter VIII' shall be replaced by 'paragraph 46 of Chapter IX';
5) in Article 20 (d) 'paragraph 57 of Chapter X' shall be replaced by 'paragraph 58 of Chapter XI'.
Article 3
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1993. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 4
This Directive is addressed to the Member States. | [
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"UKSI19950539",
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31991L0440 | 1991 | Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways
Having regard to the Treaty establishing the Europaen Economic Community, and in particular Article 75 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas greater integration of the Community transport sector is an essential element of the internal market, and whereas the railways are a vital part of the Community transport sector;
Whereas the efficiency of the railway system should be improved, in order to integrate it into a competitive market, whilst taking account of the special features of the railways;
Whereas, in order to render railway transport efficient and competitive as compared with other modes of transport, Member States must guarantee that railway undertakings are afforded a status of independent operators behaving in a commercial manner and adapting to market needs;
Whereas the future development and efficient operation of the railway system may be made easier if a distinction is made between the provision of transport services and the operation of infrastructure; whereas given this situation, it is necessary for these two activities to be separately managed and have separate accounts;
Whereas, in order to boost competition in railway service management in terms of improved comfort and the services provided to users, it is appropriate for Member States to retain general responsibility for the development of the appropriate railway infrastructure;
Whereas, in the absence of common rules on allocation of infrastructure costs, Member States shall, after consulting the infrastructure management, lay down rules providing for the payment by railway undertakings and their groupings for the use of railway infrastructure; whereas such payments must comply with the principle of non-discrimination between railway undertakings;
Whereas Member States should ensure in particular that existing publically owned or controlled railway transport undertakings are given a sound financial structure, whilst taking care that any financial rearrangement as may be necessary shall be made in accordance with the relevant rules laid down in the Treaty;
Whereas, in order to facilitate transport between Member States, railway undertakings should be free to form groupings with railway undertakings established in other Member States;
Whereas, such international groupings should be granted rights of access and transit in the Member States of establishment of their constituent undertakings, as well as transit rights in other Member States as required for the international service concerned;
Whereas, with a view to encouraging combined transport, it is appropriate that access to the railway infrastructure of the other Member States should be granted to railway undertakings engaged in the international combined transport of goods;
Whereas it is necessary to establish an advisory committee to monitor and assist the Commission with the implementation of this Directive;
Whereas, as a result, Council Directive 75/327/EEC of 20 May 1975 on the improvement of the situation of railway undertakings and the harmonization of rules governing financial relations between such undertakings and States(4) should be repealed,
SECTION I Objective and scope
Article 1
The aim of this Directive is to facilitate the adoption of the Community railways to the needs of the Single Market and to increase their efficiency;
-by ensuring the management independance of railway undertakings;
-by separating the management of railway operation and infrastructure from the provision of railway transport services, separation of accounts being compulsory and organizational or institutional separation being optional,
-by improving the financial structure of undertakings,
-by ensuring access to the networks of Member states for international groupings of railway undertakings and for railway undertakings engaged in the international combined transport of goods.
Article 2
1. This Directive shall apply to the management of railway infrastructure and to rail transport activities of the railway undertakings established or to be established in a Member State.
2. Member States may exclude from the scope of this Directive railway undertakings whose activity is limited to the provision of solely urban, suburban or regional services.
Article 3
For the purpose of this Directive:
-'railway undertaking` shall mean any private or public undertaking whose main business is to provide tail transport services for goods and/or passengers with a requirement that the undertaking should ensure traction,
-'infrastructure manager` shall mean any public body or undertaking responsible in particular for establishing and maintaining railway infrastructure, as well as for operating the control and safety systems,
-'railway infrastructure` shall mean all the items listed in Annex I.A to Commission Regulation (EEC) N° 2598/70 of 18 December 1970 specifying the items to be included under the various headings in the forms of accounts shown in Annex I to Regulation (EEC) N° 1108/70(1), with the exception of the final indent which, for the purposes of this Directive only, shall read as follows: 'Buildings used by the infrastructure department`,
-'international grouping` shall mean any association of at least two railway undertakings established in different Member States for the purpose of providing international transport services between Member States;
-'urban and suburban services` shall mean transport services operated to meet the transport needs of an urban centre or conurbation, as well as the transport needs bewtween such centre or conurbation and surrounding areas;
-'regional services` shall mean transport services operated to meet the transport needs of a region.
SECTION II Management independence of railway undertakings
Article 4
Member States shall take the measures necessary to ensure that as regards management, administration and internal control over administrative, economic and accounting matters railway undertakings have independent status in accordance with which they will hold, in particular, assets, budgets and accounts which are separate from those of the State.
Article 5
1. Member States shall take the measure necessary to enable railway undertakings to adjust their activities to the market and to manage those activities under the responsibility of their management bodies, in the interests of providing efficient and appropriate services at the lowest possible cost for the quality of service required.
Railway undertakings shall be managed according to the principles which apply to commercial companies; this shall also apply to their public services obligations imposed by the State and to public services contracts which they conclude with the competent authorities of the Member State.
2. Railway undertakings shall determine their business plans, including their investment and financing programmes. Such plans shall be designed to achieve the undertakings' financial equilibrium and the other technical, commercial and financial management objectives; they shall also lay down the method of implementation.
3. In the context of the general policy guidelines determined by the State and taking into account national plans and contracts (which may be multiannual) including investment and financing plans, railway undertakings shall, in particular, be free to:
-establish with one or more other railway undertakings an international grouping;
-establish their internal organization, without prejudice to the provisions of Section III;
-control the supply and marketing of services and fix the pricing thereof, without prejudice to Council Regulation (EEC) N° 1191/69 of 26 June 1969 on action by Member States concerning the obligation inherent in the concept of a public service in transport by rail, road and inland waterway(1),
-take decisions on staff, assets and own procurement,
-expand their market share, develop new technologies and new services and adopt any innovative management techniques;
-establish new activities in fields associated with railway business.
SECTION III Separation between infrastructure management and transport operations
Article 6
1. Member States shall take the measures necessary to ensure that the accounts for business relating to the provision of transport services and those for business relating to the management of railway infrastructure are kept separate. Aid paid to one of these two areas of activity may not be transferred to the other.
The accounts for the two areas of activity shall be kept in a way which reflects this prohibition.
2. Member States may also provide that this separation shall require the organization of distinct divisions within a single undertaking or that the infrastructure shall be managed by a separate entity.
Article 7
1. Member States shall take the necessary measures for the development of their national railway infrastructure taking into account, where necessary, the general needs of the Community.
They shall ensure that safety standards and rules are laid down and that their application is monitored.
2. Member States may assign to railway undertakings or any other manager the responsibility for managing the railway infrastructure and in particular for the investment, maintenance and funding required by the technical, commercial and financial aspects of that management.
3. Member States may also accord the infrastructure manager, having due regard to Articles 77, 92 and 93 of the Treaty, financing consistent with the tasks, size and financial requirements, in particular in order to cover new investments.
Article 8
The manager of the infrastructure shall charge a fee for the use of the railway infrastructure for which he is responsible, payable by railway undertakings and international groupings using that infrastructure. After consulting the manager, Member States shall lay down the rules for determining this fee.
The user fee, which shall be calculated in such a way as to avoid any discrimination between railway undertakings, may in particular take into account the mileage, the composition of the train and any specific requirements in terms of such factors as speed, axle load and the degree or period of utilization of the infrastructure.
SECTION IV Improvement of the financial situation
Article 9
1. In conjunction with the existing publicity owned or controlled railway undertakings, Member States shall set up appropriate mechanisms to help reduce the indebtedness of such undertakings to a level which does not impede sound financial management and to improve their financial situation.
2. To that end, Member States may take the necessary measures requiring a separate debt amortization unit to be set up within the accounting departments of such undertakings.
The balance sheet of the unit may be charged, until they are extinguished, with all the loans raised by the undertaking both to finance investment and to cover excess operating expenditure resulting from the business of rail transport or from railway infrastructure management. Debts arising from subsidiaries' operations may not be taken into account.
3. Aid accorded by Member States to cancel the debts referred to in this Article shall be granded in accordance with Articles 77, 92 and 93 of the EEC Treaty.
SECTION V Access to railway infrastructure
Article 10
1. International groupings shall be granted access and transit rights in the Member States of establishment of their constituent railway undertakings, as well as transit rights in other Member States, for international services between the Member States where the undertakings constituting the said groupings are established.
2. Railway undertakings within the scope of Article 2 shall be granted acces on equitable conditions to the infrastructure in the other Member States for the purpose of operating international combined transport goods services.
3. Railway undertakinks engaged in international combined transport of goods and international groupings shall conclude the necessary administrative, technical and financial agreements with the managers of the railway infrastructure used with a view to regulating traffic control and safety issues concerning the international transport services referred to in paragraphs 1 and 2. The conditions governing such agreements shall be non-discriminatory.
SECTION VI Final provisions
Article 11
1. Member States may bring any question concerning the implementation of this Directive to the attention of the Commission. After consulting the committee provided for in paragraph 2 on these questions, the Commission shall take the appropriate decisions.
2. The Commission shall be assisted by an advisory committee composed of the representatives of the Member States and chaired by the representative of the Commission.
The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.
Article 12
The provisions of this Directive shall be without prejudice to Council Directive 90/531/EEC of 17 September 1990 on the procurment procedure of entities operating in the water, energy, transport and telecommunications sectors(1).
Article 13
Decision 75/327/EEC is hereby repealed as from 1 January 1993.
Reference to the repealed Decision shall be understood to refer to this Directive.
Article 14
Before 1 January 1995, the Commission shall submit to the Council a report on the implementation of this Directive accompanied, if necessary, by suitable proposals on continuing Community action to develop railways, in particular in the field of the international transport of goods.
Article 15
Member States shall, after consultation with the Commission, adopt the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1993. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 16
This Directive is addressed to the Member States. | [
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] |
31991L0498 | 1991 | Council Directive 91/498/EEC of 29 July 1991 on the conditions for granting temporary and limited derogations from specific Community health rules on the production and marketing of fresh meat
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas fresh meat is included on the list of products in Annex II to the Treaty; whereas their marketing provides a source of income for a large part of the farming population;
Whereas, to ensure rational development of the sector, increase productivity and progressively to establish the conditions for an internal market, health rules applying
to production and marketing have been laid down at Community level by Directive 64/433/EEC (4) as amended and codified by Directive 91/497/EEC (5);
Whereas it is possible that, because of particular circumstances, some establishments will be unable, by
1 January 1993, to comply with all of the specific rules laid down; whereas in order to take account of local situations and to prevent abrupt closures of establishments, arrangements should be made for limited and temporary derogations for establishments in operation before 1 January 1992;
Whereas the granting of derogations from specific Community health rules to certain establishments is without prejudice to the requirement that all production and marketing operations conform to the hygiene rules laid down by Directive 64/433/EEC;
Whereas to forestall any risk of abuse, these derogations must be strictly controlled by the Commission; whereas to this end, there should be a procedure for close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee,
Article 1
Member States shall ensure that from 1 January 1996:
- all establishments fulfil the requirements of Directive 64/433/EEC,
- meat from such establishments bears the health
mark specified in Annex I, Chapter X of Directive 64/433/EEC or, in the case of establishments referred to in Article 4 of the said Directive, bears the health mark specified in paragraph 3 of that Article.
Article 2
1. Member States may, until 31 December 1995, authorize establishments which, on the date on which this Directive is notified, have not been judged to comply with the requirements laid down by Directive 64/433/EEC for their approval, to derogate from some of the requirements laid down in points 1 to 13 of Annex I to Directive 64/433/EEC provided that meat from such establishments bears the national mark.
2. Derogations as referred to in paragraph 1 may be granted only to establishments which have, before 1 April 1992, submitted an application for a derogation to the relevant national authority.
This application must be accompanied by a work plan and programme indicating the period within which it would be possible for the establishment to comply with the requirements referred to in paragraph 1.
Where financial assistance is requested from the Community, only requests in respect of projects complying with the requirements of Directive 64/433/EEC can be accepted.
Member States shall submit to the Commission before 1 July 1992 a list of the establishments for which it is proposed to grant a derogation. This list shall, for each individual establishment, specify the type and duration of the derogations envisaged, the nature of checks made on meat from the establishment in question and the staff responsible for carrying out those checks.
National approval of establishments which have not submitted applications for a derogation by the date referred
to in the first subparagraph or whose applications have been
refused by the Member State concerned shall be withdrawn before 1 January 1993.
On receipt of the list referred to in the fourth paragraph submitted by a Member State, the Commission shall have two months within which to examine that list and its submission, if necessary after amendment to the Standing Veterinary Committee which shall decide in accordance with the procedure laid down in Article 6.
3. The list of establishments which have been granted derogations shall be published by the Commission.
Article 3
With effect from 1 July 1992, Article 2 of Council Directive 88/409/EEC of 15 June 1988 laying down the health rules applying to meat intended for the domestic market and the levels of the fees to be charged, pursuant to Directive 85/73/EEC, in respect of the inspection of such meat (6) shall be replaced by the following:
'Article 2
As from 1 January 1996 Member States shall take
the necessary steps to ensure that all fresh meat produced
in their territory for marketing there is obtained in
an approved establishment in accordance with the provisions of Directive 64/433/EEC.'
Article 4
Until 31 December 1997, the Hellenic Republic shall be authorized to continue, in less-favoured sparsely populated areas to be recognized in accordance with the procedure laid down in Article 6, the slaughtering of sheep and goats which, from 15 February to 15 May, is carried out in premises which do not satisfy the requirements of Annexes I and II to Directive 64/433/EEC and to derogate with respect to the requirement for hot water from the provisions of Annex II, point 2 (a) to that Directive.
The Hellenic Republic shall ensure that meat obtained under this derogation can be placed on the market only in Greece and only after it has undergone a post-mortem inspection by
an official veterinarian and has received the health mark provided for in Article 4A (3) of Directive 64/433/EEC.
The Council shall, on the basis of a report from the Commission, accompanied by possible proposals on which it will decide by a qualified majority, re-examine this Article.
Article 5
The Federal Republic of Germany may, in accordance with the procedure set out in Article 6, obtain a further period for establishments situated in the Laender of the former German Democratic Republic within the framework of current restructuring plans.
Article 6
Where reference is made to the procedure provided for in this Article, the rules applicable shall be those set out in Article 16 of Directive 64/433/EEC.
Article 7
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 2 (2) on 1 January 1992 and with the other provisions of this Directive on 1 January 1993. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 8
This Directive is addressed to the Member States. | [
"UKSI19922037"
] |
31991L0508 | 1991 | Commission Directive 91/508/EEC of 9 September 1991 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 91/336/EEC (2), and in particular Article 7 thereof,
Whereas Directive 70/524/EEC provides for regular amendment of the content of its Annexes to take account of advances in scientific and technical knowledge; whereas the Annexes have been codified by Commission Directive 91/248/EEC (3);
Whereas a new use of the antibiotic 'salinomycin sodium', the sweetener 'neohesperidine dihydrochalcone', the vitamin D3 and the trace element 'iron', in the form of a ferrous chelate of amino acids hydrate has been successfully tested in certain Member States; whereas, on the basis of experience gained, it appears that these new uses can be authorized throughout the Community;
Whereas certain studies have cast doubt on the effectiveness of the carotenoid 'violaxanthin', whereas it is advisable to ban the use of this colourant;
Whereas the use of a new coccidiostat has been successfully tested in certain Member States; whereas it is suitable provisionally to authorize this new use at national level while waiting for it to be authorized at Community level;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs,
Article 1
The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex hereto.
Article 2
Member States shall, by 30 November 1992 at the latest, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1. They shall inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19912840"
] |
31991L0542 | 1991 | Council Directive 91/542/EEC of 1 October 1991 amending Directive 88/77/EEC on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous pollutants from diesel engines for use in vehicles
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
Whereas the first programme of action of the European Communities on the protection of the environment, approved by the Council on 22 November 1973, called for account to be taken of the latest scientific advances in combating atmospheric pollution caused by gases emitted from motor vehicles and for Directives adopted previously to be amended accordingly; whereas the third programme of action provides for additional efforts to be made to reduce considerably the present level of emissions of pollutants from motor vehicles;
Whereas Directive 88/77/EEC (4) lays down the limit
values for the emissions of carbon monoxide, unburnt
hydrocarbons and nitrogen oxides from diesel engines for
use in motor vehicles on the basis of a test procedure
representative for European driving conditions for the vehicles concerned; whereas in accordance with Article 6 of that Directive these limit values should be further reduced in the light of technical progress and a limit value for particulate emissions fixed;
Whereas, in laying down the new standards and test procedures, it is necessary to take account of future traffic growth in the European Community; whereas an increase in vehicle registrations, particularly lorries, is to be expected in anticipation of the internal market;
Whereas the work undertaken by the Commission in that sphere has shown that the Community motor industry has had available for some time or is currently perfecting technologies which allow a considerable reduction of the limit values in question and the particulate standards; whereas, because of this and the likely increase in the number of motor vehicles in Europe as a result of the internal market, it is imperative to reduce emission limit values radically in the interests of environmental protection and public health;
Whereas it is appropriate to introduce these more stringent standards in two stages, the first coinciding with the implementation dates of the new stringent European emission standards for passenger cars; whereas the second stage aims at the establishment of a longer-term orientation for the European motor industry in fixing limit values which are based on the expected performance of technologies which
are still under development, granting to industry a sufficient lead time for perfecting such technologies; whereas the enforcement of the second stage requires as a prerequisite the meeting of certain framework conditions in relation to the availability of low-sulphur diesel fuel and of a corresponding reference fuel for emissions testing, to the progress achieved on emission control technologies, and to the availability of an improved method for the control of production conformity which the Commission adopts in application of the procedure for adaptation to technical progress set out in Article 4 of Directive 88/77/EEC; whereas the Commission will present, before the end of 1993, a comprehensive report on these matters to the Council enabling the latter to decide, if necessary, before 30 September 1994, the limit value for the particulate emissions to be retained for the second stage;
Whereas an addition to the European 13-mode test cycle for checking the limit values of gaseous pollutants should be considered to take account of dynamic processes such as acceleration; whereas the Commission will submit a report on this subject in due course;
Whereas, under the spot-check procedure in production testing, the production limit value for pollutants need only be maintained on average; whereas an improved sampling procedure would be highly desirable; whereas the Commission will submit appropriate proposals;
Whereas, so that the limit values laid down can be complied with effectively, a special annual mandatory exhaust test must be introduced for all the vehicles in question; whereas the Commission will submit appropriate proposals;
Whereas in order to allow the European environment to benefit to the maximum from these provisions and at the same time ensure the unity of the market, it is necessary to impose the new, very stringent standards;
Whereas it would be desirable for the Member States to take the initiative to encourage, by means of tax incentives, compliance with European emission standards ahead of time, it being understood that such incentives were applicable to all models marketed in a Member State;
Whereas the process of tightening up the standards would also be speeded up if Member States introduced schemes
to encourage the purchasers of new cars to scrap their
old vehicles or, as far as possible, surrender them for recycling;
Whereas the the Community should study and develop alternative systems of propulsion, alternative fuels and corresponding transport concepts and provide financial support for research and development in these fields,
Article 1
Directive 88/77/EEC is hereby amended as follows:
1. The title is replaced by the following:
'Council Directive
of 3 December 1987
on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from diesel engines for use in vehicles'
2. Annexes I, II, III, V and VIII are amended in accordance with the Annex to this Directive.
Article 2
1. From 1 January 1992 no Member State may, on grounds relating to the gaseous and particulate pollutants emitted from an engine:
- refuse to grant EEC type-approval, or to issue the document provided for in the last indent of Article 10 (1) of Council Directive 70/156/EEC (5), or to grant national type-approval for a type of vehicle propelled by a diesel engine, or
- prohibit the registration, sale, entry into service or use of such new vehicles, or
- refuse to grant EEC type-approval, or to grant national type-approval for a type of diesel engine, or
- prohibit the sale or use of new diesel engines,
if the requirements of the Annexes to Directive 88/77/EEC are satisfied.
2. Member States may no longer grant EEC type-approval or issue the document provided for in the last indent of Article 10 (1) of Directive 70/156/EEC, and shall refuse national type-approval, of types of diesel engines and types of vehicle propelled by a diesel engine:
- from 1 July 1992 where the emissions of gaseous and particulate pollutants from the engine do not comply with the limit values set out in line A,
- from 1 October 1995 where the emission of gaseous and particulate pollutants from the engine do not comply with the limit values set out in line B
of the table in section 6.2.1. of Annex I to Directive 88/77/EEC.
3. Until 30 September 1993, paragraph 2 shall not apply to types of vehicle propelled by a diesel engine if the latter is
described in the Annex to a type-approval certificate granted before 1 July 1992 in accordance with Directive 88/77/EEC.
4. With the exception of vehicles and diesel engines intended for export to third countries, Member States shall prohibit the registration, sale, entry into service and use of new vehicles propelled by a diesel engine and the sale and use of new diesel engines:
- from 1 October 1993, where the emissions of gaseous and particulate pollutants from the engine do not comply with the limit values set out in line A,
- from 1 October 1996, where the emissions of gaseous and particulate pollutants from the engine do not comply with the limit values set out in line B
of the table in section 8.3.1.1. of Annex I to Directive 88/77/EEC.
Article 3
Member States may make provision for tax incentives for the vehicles covered by this Directive. Such incentives shall meet the provisions of the Treaty as well as the following conditions:
- they shall apply to all domestic car production and to vehicles imported for marketing in a Member State and fitted with equipment allowing the European standards to be met in 1996 to be satisfied ahead of time,
- they shall cease upon the date set in Article 2 (4) for the compulsory entry into force of the emission values for new vehicles,
- they shall be of a value, for each type of vehicle, substantially lower than the actual cost of the equipment fitted to meet the values set and of its fitting on the vehicle.
The Commission shall be informed of any plans to introduce or amend the tax incentives referred to in the first subparagraph in sufficient time to allow it to submit comments.
Article 4
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof.
When these measures are adopted by the Member States they shall contain a reference to this Directive or be accompanied
by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 5
1. Before the end of 1991, the Council, acting by a qualified majority on the basis of a Commission proposal, shall decide on measures to ensure the availability in the Member States of improved diesel fuel with a maximum permitted sulphur content of 0,05 %.
2. Before the end of 1993 the Commission shall give an account, in a report to the Council, of the progress made regarding:
- the availability of techniques for controlling air-polluting emissions from diesel engines, particularly those of less than 85 kW,
- a new statistical method for the monitoring of production conformity to be adopted in accordance with Article 4 of Directive 88/77/EEC.
If necessary it shall submit to the Council a proposal for revising upwards the limit values for particulate emissions. The Council shall take a decision on the basis of the proposal not later than 30 September 1994.
3. Before the end of 1996, in the light of the technical progress achieved, the Commission shall submit to the Council a revision of the limit values for polluting emissions combined if necessary with a revision of the test procedure. The new limit values shall not be applicable before 1 October 1999 as regards new type-approvals.
Article 6
The Council, acting by a qualified majority on a proposal from the Commission, which shall take account of the results of current work on the greenhouse effect, shall decide on the measures to be taken to limit CO2 emissions from motor vehicles.
Article 7
This Directive is addressed to the Member States. | [
"UKSI19912830",
"UKSI19912681",
"UKSI19922137"
] |
31991L0632 | 1991 | Commission Directive 91/632/EEC of 28 October 1991 adapting to technical progress for the fifteenth time Council Directive 67/548/EEC on the approximation of the laws, Regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Directive 79/831/EEC (2), and in particular Articles 19, 20 and 21 thereof,
Whereas the Federal Republic of Germany and the Kingdom of Denmark have requested a change in the labelling of a number of substances and notified the Commission accordingly under Article 23 of Directive 67/548/EEC;
Whereas examination of the list of dangerous substances in Annex I to Directive 67/548/EEC has shown that this list needs to be adapted in the light of present scientific and technical knowledge;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations,
Article 1
Annex I of Directive 67/548/EEC is hereby amended as follows:
1. The entries in Annex I of this Directive replace the corresponding entries in Annex I,
4. The entries in Annex II of this Directive are included for the first time in Annex I.
3. The entries with the EC No shown in Annex III of this Directive are deleted from Annex I.
Article 2
1. Not later than 1 July 1993 the Member States shall implement the laws, regulations and administrative provisions necessary to comply with this Directive. Member States shall immediately inform the Commission thereof.
2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19931746",
"UKSI19933050"
] |
31991L0630 | 1991 | Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards fo the protection of pigs
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas all Member States have ratified the European Convention on the protection of animals kept for farming purposes; whereas the Community has also approved this Convention by Decision 78/923/EEC (4) and has deposited its instrument of approval;
Whereas the European Parliament, in its resolution of 20 February 1987 on animal welfare policy (5), called on the Commission to make proposals on minimum standards for the intensive farming of pigs;
Whereas pigs, being live animals, are included in the list of products set out in Annex II of the Treaty;
Whereas the keeping of pigs is an integral part of agriculture; whereas it constitutes a source of revenue for part of the agricultural population;
Whereas differences which may distort conditions of competition interfere with the smooth running of the organization of the common market in pigs and pig products;
Whereas there is therefore a need to establish common minimum standards for the protection of pigs kept for rearing and fattening in order to ensure rational development of production;
Whereas it is necessary for official services, producers, consumers and others to be kept informed of developments in this field; whereas the Commission should therefore, on the basis of a report from the Scientific Veterinary Committee, pursue actively scientific research into the best pig-rearing system(s) from the point of view of pig welfare; whereas provision should accordingly be made for an interim period to enable the Commission to complete this task successfully,
Article 1
This Directive lays down the minimum standards for the protection of pigs confined for rearing and fattening.
Article 2
For the purposes of this Directive, the following definitions shall apply:
1. 'pig`: an animal of the porcine species, of any age, kept for breeding or fattening;
2.
'boar`: a male pig after puberty, intended for breeding;
3.
'gilt`: a female pig after puberty and before farrowing;
4.
'sow`: a female pig after the first farrowing;
5.
'farrowing sow`: a female pig between the perinatal period and the weaning of the piglets;
6.
'dry pregnant sow`: a sow between weaning her piglets and the perinatal period;
7.
'piglet`: a pig from birth to weaning;
8.
'weaner`: a pig from weaning to the age of ten weeks;
9.
'rearing pig`: a pig from ten weeks to slaughter or service;
10.
'competent authority`: a competent authority within the meaning of Article 2 (6), of Directive 90/425/EEC (6).
Article 3
Member States shall ensure that:
1. - from 1 January 1994, all holdings newly-built or rebuilt and/or brought into use for the first time after that date shall comply with at least the following requirement:
the unobstructed floor area available to each weaner or rearing pig reared in a group must be at least:
- 0,15 m$ for a pig of an average weight of 10 kg or less,
- 0,20 m$ for a pig of an average weight of between 10 kg and 20 kg,
- 0,30 m$ for a pig of an average weight of between 20 kg and 30 kg,
- 0,40 m$ for a pig of an average weight of between 30 kg and 50 kg,
- 0,55 m$ for a pig of an average weight of between 50 kg and 85 kg,
- 0,65 m$ for a pig of an average weight of between 85 kg and 110 kg,
- 1,00 m$ for a pig of an average weight of more than 110 kg;
- from 1 January 1998, the minimum standards provided for above shall apply to all holdings;
2. the construction or conversion of installations in which sows and gilts are tethered shall be prohibited after 31 December 1995.
However, the use of installations built prior to 1 January 1996 which do not meet the requirements of point 1 may be authorized by the competent authority in the light of the results of the inspections provided for in Article 7 (1), for a period which shall under no circumstances extend beyond 31 December 2005.
The provisions of this Article shall not apply to holdings with fewer than six pigs or five sows with their piglets.
Article 4
1. Member States shall ensure that the conditions for rearing pigs comply with the general provisions laid down in the Annex.
However, until 30 June 1995, the Member States' competent authorities may authorize derogations from paragraphs 3, 5, 8 and 11 of Chapter I of the Annex.
2. Moreover, before this Directive enters into force, the Commission, in cooperation with the Member States, shall issue a recommendation defining any additional minimum standards for the protection of pigs supplementing those in the Annex.
Article 5
The provisions of the Annex may be amended in accordance with the procedure laid down in Article 10, in order to take account of scientific progress.
Article 6
By 1 October 1997, the Commission shall submit to the Council a report, drawn up on the basis of an opinion from the Scientific Veterinary Committee, on the intensive pig-rearing system(s) which comply with the welfare requirements of pigs from the pathological, zootechnical, physiological and behavioural points of view and on the socio-economic implications of the different systems. The report shall particularly take into account the welfare of sows reared in varying degrees of confinement and in groups and shall be accompanied by appropriate proposals which take account of the conclusions of the report.
The Council shall act by qualified majority on those proposals no later than three months after their submission.
Article 7
1. Member States shall ensure that inspections are carried out under the responsibility of the competent authority in order to check that the provisions of this Directive and its Annex are being complied with.
These inspections, which may be carried out on the occasion of checks made for other purposes, shall each year cover a statistically representative sample of the different rearing systems used in each Member State.
2. The Commission shall, in accordance with the procedure laid down in Article 10, draw up a code of rules to be applied in carrying out the inspections provided for in paragraph 1.
3. Every two years, by the last working day in April and for the first time by 30 April 1996, Member States shall inform the Commission of the results of the inspections carried out during the previous two years in accordance with this Article, including the number of inspections carried out in proportion to the number of holdings in their territory.
Article 8
Animals imported from non-member countries must, with respect to the requirements for their welfare, whilst being reared, receive treatment at least equivalent to that guaranteed by this Directive to animals of Community origin. This requirement must be stated in a certificate issued by the competent authority of the non-member country concerned.
Article 9
Veterinary experts from the Commission may, where necessary for the uniform application of this Directive, carry out on-the-spot checks in cooperation with the competent authorities. The persons carrying out these checks shall implement the special personal hygiene measures necessary to exclude any risk of transmission of disease.
The Member State in the territory of which a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the competent authority of the Member State concerned of the results of the checks.
The competent authority of the Member State concerned shall take any measures which may prove necessary to take account of the results of the check.
With regard to relations with non-member countries, the provisions of Chapter III of Directive 91/496/EEC (1) shall apply.
General rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 10.
Article 10
1. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter without delay to the Standing Veterinary Committee set up by Directive 68/361/EEC (2), hereinafter referred to as the 'Committee`, either on his own initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
4. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, within three months of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission except where the Council has decided against the measures by a simple majority.
Article 11
1. Member States shall bring into force the laws, regulations and administrative provisions, including any sanctions, necessary to comply with this Directive not later than 1 January 1994. They shall forthwith inform the Commission thereof.
Where Member States adopt these provisions, the latter shall include a reference to this Directive or shall be accompanied by such a reference on their official publication. The details of this reference shall be adopted by the Member States.
2. However, from the date set in paragraph 1, Member States may, in compliance with the general rules of the Treaty, maintain or apply within their territories stricter provisions for the protection of pigs than those laid down in this Directive. They shall inform the Commission of any such measures.
Article 12
This Directive is addressed to the Member States. | [
"UKSI19942126"
] |
31991L0628 | 1991 | Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport and amending Directives 90/425/EEC and 91/496/EEC
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas in its resolution of 20 February 1987 on animal welfare policy (4), the European Parliament called upon the Commission to put forward proposals on the protection of animals during transport;
Whereas in order to eliminate technical barriers to trade in live animals and to allow the market organizations in question to operate smoothly, while ensuring a satisfactory level of protection for the animals concerned, the Community has adopted rules in this field;
Whereas all Member States have ratified the European Convention for the protection of animals during international transport and have signed the additional Protocol enabling the Community as such to accede to the said Convention;
Whereas Council Regulation (EEC) No 3626/82 of 3 December 1982 on the implementation in the Community of the Convention on international trade in endangered species of wild fauna and flora (5), hereinafter referred to as 'Cites`, regulates the conditions of transport of certain species;
Whereas Directive 77/489/EEC (6) laid down rules on the protection of animals during international transport; whereas Directive 81/389/EEC (7) established measures for the implementation of Directive 77/489/EEC, and in particular introduced controls at the internal frontiers of the Community;
Whereas in order to achieve the same objectives, and in particular the protection of animals during transport, it is necessary in the context of establishing the internal market to modify the rules of Directive 90/425/EEC (8), inter alia with a view to harmonizing prior checks relating to animal welfare during transport;
Whereas within this framework the transport of animals within, to and from the Community must be covered, and systematic checks at the internal frontiers of the Community must be abolished;
Whereas for reasons of animal welfare the transport over long distances of animals, including animals for slaughter, should be reduced as far as possible;
Whereas the rules proposed must ensure more effective protection of animals during transport;
Whereas Directive 91/496/EEC (9) should be amended so as to adapt it to this Directive; whereas Directives 77/489/EEC and 81/389/EEC should furthermore be repealed,
CHAPTER I General provisions
Article 1
1. This Directive applies to the transport of:
(a) domestic solipeds and domestic animals of the bovine, ovine, caprine and porcine species;
(b)
poultry, domestic birds and domestic rabbits;
(c)
domestic cats and domestic dogs;
(d)
other mammals and birds;
(e)
other vertebrate animals and cold-blooded animals.
( 7) OJ N° L 224, 18. 8. 1990, p. 29. Directive as last amended by Directive 91/496/EEC (OJ N° L 268, 24. 9. 1991, p. 56).
(§) OJ N° L 268, 24. 9. 1991, p. 56.
2. This Directive does not apply:
(a)
to travellers transporting pet animals for non-profit-making purposes;
(b)
without prejudice to the relevant national provisions, to the transport of animals carried out:
- up to a maximum distance of 50 km counted from the start of the transport of the animals to the place of destination, or
- by stock farmers or fatteners using agricultural vehicles or means of transport belonging to them in cases where the geographical circumstances call for non-profit-making seasonal transhumance of certain types of animal.
Article 2
1. For the purposes of this Directive, the definitions in Article 2 of Directives 89/662/EEC (1), 90/425/EEC, 90/675/EEC (2) and Directive 91/496/EEC shall apply as necessary.
2. In addition, the following definitions shall apply:
(a) 'means of transport`, those parts of road vehicles, rail vehicles, ships and aircraft used for loading and carrying animals, as well as containers for land, sea or air transport;
(b)
'transport`, any movement of animals, effected by a means of transport, which involves loading and unloading the animals;
(c)
'staging point`, a place where the journey is interrupted to rest, feed or water the animals;
(d)
'transfer point`, a place where transport is interrupted to transfer animals from one means of transport to another;
(e)
'place of departure`, the place at which, without prejudice to the provisions of Article 1 (2) (b), the animal is first loaded on to a means of transport, or any place where the animals have been unloaded and accommodated for at least 10 hours, watered, fed and, if necessary, cared for, but excluding any staging or transfer point.
Markets and assembly centres approved in accordance with Community legislation may also be regarded as places of departure:
- where the first place of loading of the animals is less than 50 km from the said markets or assembly centres,
- where, although the distance referred to in the first indent is over 50 km, the animals have had a rest period of a length to be determined in accordance with the procedure laid down in Article 17 and have been watered and fed before being reloaded;
(f)
'place of destination`, the place at which an animal is finally unloaded from a means of transport, but excluding a staging point or a transfer point;
(g)
'journey`, transport from place of departure to place of destination.
CHAPTER II Transport and controls in Community territory
Article 3
1. Member States shall ensure that:
(a) the transport of animals within, to and from each Member State shall be effected in accordance with this Directive and, in respect of the animals referred to in:
- Article 1 (a), the provisions of Chapter I of the Annex,
- Article 1 (b), the provisions of Chapter II of the Annex,
- Article 1 (c), the provisions of Chapter III of the Annex,
- Article 1 (d), the provisions of Chapter IV of the Annex,
- Article 1 (e), the provisions of Chapter V of the Annex;
(b)
no animal shall be transported unless it is fit for the intended journey and unless suitable provisions have been made for its care during the journey and on arrival at the place of destination. Animals that are ill or injured shall not be considered fit for transport. However, this provision shall not apply to:
i(i) animals that are slightly injured or ill whose transport would not cause unnecessary suffering;
(ii)
animals that are transported for scientific research purposes approved by the competent authority;
(c)
animals that fall ill or are injured during transport shall receive first-aid treatment as soon as possible; they shall be given appropriate veterinary treatment and if necessary undergo emergency slaughter in a way which does not cause them any unnecessary suffering.
2. Notwithstanding paragraph 1 (b), Member States may permit the transport of animals for emergency veterinary treatment or slaughter under conditions which do not meet the requirements of this Directive. Member States shall ensure that any such transport is permitted only where no unnecessary suffering or ill treatment is caused to the animals concerned. If necessary, specific rules for the application of this paragraph shall be adopted in accordance with the procedure laid down in Article 17.
3. Without prejudice to the requirements laid down in points 1 (a) and (b) and in the Annex to this Directive, the Council, acting by a qualified majority on a proposal from the Commission, shall lay down appropriate additional conditions for the transport of certain types of animal such as solipeds, wild birds and marine mammals in order to safeguard their welfare.
Pending implementation of these provisions, Member States may, subject to the general provisions of the Treaty, apply relevant national additional rules.
Article 4
Member States shall ensure that animals are identified and registered throughout their journey in accordance with Article 3 (1) (c) of Directive 90/425/EEC and are accompanied by the documentation required by Community or national legislation enabling the competent authority to check:
- their origin and their ownership,
- their place of departure and place of destination,
- the date and time of departure.
Article 5
Member States shall ensure that:
1. any natural or legal person transporting animals for profit:
(a) is registered in a manner enabling the competent authority to check that the requirements of this Directive are complied with;
(b)
transports animals covered by this Directive using means of transport meeting the requirements laid down in the Annex;
(c)
does not transport any animal, or cause any animal to be transported, in a way which may cause injury or unnecessary suffering to that animal;
2.
the person in charge of the animal transport undertaking:
(a)
entrusts the transport to staff who possess the necessary knowledge to administer any appropriate care to the animals transported;
(b)
draws up, for journeys exceeding 24 hours from the place of departure and taking account of the place of destination, an itinerary - including any staging and transfer points - whereby it can be ensured that the animals are rested, fed and watered and, if necessary, unloaded and given accommodation in accordance with the requirements of this Directive for the type of animal to be transported;
(c)
is able, according to the species transported and where the journey takes more than 24 hours, to demonstrate that steps have been taken to meet the animals' needs for food and water during the journey even where the route plan is changed or where the journey is interrupted for reasons beyond his control;
(d)
ensures that the animals are transported without delay to their place of destination, notwithstanding drivers' normal rest periods;
(e)
ensures that during the journey the consignment is accompanied by the original of the route plan referred to in (b), with the addition of the date, place and time of departure;
(f)
keeps for a period fixed by the competent authority a second copy of the abovementioned route plan, to be submitted on request to the competent authority for verification;
(g)
where animals are travelling unaccompanied, ensures that the consignor has presented them for transport in accordance with the provisions of this Directive and that the consignee is prepared to receive them;
3.
the staging points, agreed upon in advance by the person in charge referred to at 2, are regularly checked by the competent authority.
Article 6
1. Directive 90/425/EEC shall be amended as follows:
(a) the third paragraph of Article 1 shall be replaced by the following:
'This Directive shall not affect checks carried out as part of tasks conducted in a non-discriminatory manner by authorities responsible for the general application of laws in a Member State.`;
(b)
the following reference shall be added to section I of Annex A:
'Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport and amending Directives 90/425/EEC and 91/496/EEC. (OJ N° L 340, 11. 12. 1991, p. 17).`
2. The certificates or documents referred to in Article 3 of Directive 90/425/EEC shall be supplemented in accordance with the procedure laid down in Article 17, in order to take account of the requirements of this Directive.
3. The exchange of information between authorities in compliance with the requirements of this Directive must be integrated into the computerized system provided for in Article 20 of Directive 90/425/EEC (Animo) and, as regards imports from third countries, into the Shift project, in accordance with Article 12 (4) of Directive 91/496/EEC.
The detailed rules for the application of this paragraph shall be adopted in accordance with the procedure laid down in Article 17.
Article 7
1. Member States shall ensure that the necessary measures are taken to prevent or reduce to a minimum any delay during transport or suffering by animals when strikes or other unforeseeable circumstances impede the application of this Directive. In particular, special arrangements shall be made at ports, airports, railway stations, marshalling yards, and border inspection posts referred to in Article 6 of Directive 91/496/EEC to expedite the transport of animals under conditions in keeping with the requirements of this Directive.
2. Without prejudice to Community animal health requirements laid down elsewhere, no consignment of animals shall be detained during transport unless it is strictly necessary for the welfare of the animals. If any consignment of animals has to be detained during transport for more than two hours, appropriate arrangements shall be made for the care of the animals and, where necessary, their unloading and accommodation.
Article 8
Member States shall ensure that, in accordance with the principles and rules of control laid down in Directive 90/425/EEC, the competent authorities check that the requirements of this Directive have been complied with, by carrying out non-discriminatory inspections of:
(a) means of transport and animals arriving at their place of destination;
(b)
means of transport and animals at markets, at places of departure, at staging points and at transfer points;
(c)
the particulars on the accompanying documents.
Furthermore, where the competent authority of a Member State has information leading it to suspect an infringement, checks may also be carried out during the transport of animals on its territory.
This Article shall not affect checks carried out as part of tasks conducted in a non-discriminatory manner by authorities responsible for the general application of laws in a Member State.
Article 9
1. If it is found in the course of transport that the provisions of this Directive are not being or have not been complied with, the competent authority of the place at which such a finding is made shall require the person in charge of the means of transport to take any action which the competent authority considers necessary in order to safeguard the welfare of the animals concerned.
Depending on the circumstances of each case, such action may include:
(a) arranging for the journey to be completed or the animals to be returned to their place of departure by the most direct route, provided that this course of action would not cause unnecessary suffering to the animals;
(b)
arranging for the animals to be held in suitable accommodation with appropriate care until the problem is resolved;
(c)
arranging for the humane slaughter of the animals. The destination and use of the carcases of these animals shall be governed by the provisions laid down in Directive 64/433/EEC (1).
2. If the person in charge of the means of transport fails to comply with the instructions of the competent authority, the latter shall immediately have the measures in question carried out and shall recover the costs of such measures in the appropriate manner.
3. Rights of appeal existing under the laws in force in the Member States against decisions by the competent authorities shall not be affected by this Directive.
Decisions taken by the competent authorities of the Member States and the reasons for such decisions shall be notified to the consignor or his representative and to the competent authority of the Member State of dispatch.
If the consignor or his representative so requests, the said decisions and reasons shall be forwarded to him in writing with details of the rights of appeal which are available to him under the law in force in the Member State of destination and of the procedure and time limits applicable.
However, in the event of a dispute, the two parties concerned may, if they so agree, within a maximum period of one month, submit the dispute for the assessment of an expert whose name appears on a list of Community experts to be drawn up by the Commission.
Such experts shall issue their opinions within not more than 72 hours. The parties shall abide by the expert's opinion, with due regard for Community veterinary legislation.
Article 10
1. Commission experts may, to the extent necessary for uniform application of this Directive, carry out on-the-spot checks in collaboration with the competent authorities of the Member States. The Member State in whose territory the inspections are carried out shall provide the experts with any assistance required for the accomplishment of their task. The Commission shall inform the Member States of the results of these checks.
2. Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 17.
CHAPTER III Importation from third countries
Article 11
1. The rules laid down by Directive 91/496/EEC shall apply, in particular with regard to the organization of and follow-up to the checks.
2. The importation, transit and transport into and through Community territory of live animals covered by this Directive coming from third countries shall be authorized only if the exporter and/or importer gives a written undertaking to comply with the requirements of this Directive and has made arrangements to comply with them.
3. With effect from 1 January 1993, the first subparagraph of Article 4 (2) (d) of Directive 91/496/EEC shall be replaced by the following:
'(d) verification of compliance with the requirements of Council Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport and amending Directives 90/425/EEC and 91/496/EEC (*).
(*) OJ N° L 340, 11. 12. 1991, p. 17`.
4. The certificate or documents provided for in the third indent of Article 4 (1) of Directive 91/496/EEC shall be supplemented in accordance with the procedure laid down in Article 17, in order to take account of the requirements of this Directive.
Pending adoption of these provisions, the relevant national rules shall apply, subject to the general rules laid down by the Treaty.
CHAPTER IV Final provisions
Article 12
The rules and information procedures set out in Directive 89/608/EEC (;) shall apply mutatis mutandis for the purposes of this Directive.
(;) OJ N° L 351, 2. 12. 1989, p. 34.
Article 13
1. Before 1 July 1992, the Commission shall submit a report drawn up on the basis of an opinion from the Scientific Veterinary Committee, possibly accompanied by proposals, on:
- the question of fixing maximum journey times for certain types of animal;
- the intervals laid down in Chapter I, A (2) (d) of the Annex;
- the length of the rest provided for in Article 5 (2) (b);
- the loading density standards applicable to the transport of certain types of animal;
- the standards to be met by means of transport as regards the transport of certain types of animal.
The Council shall act on these proposals by a qualified majority.
2. In accordance with the procedure laid down in Article 17 and after consulting the Scientific Veterinary Committee, the Commission shall lay down the Community criteria to be met by staging points with regard to the feeding, watering, loading, unloading and, where appropriate, accommodation of certain types of animal.
3. Three years after the implementation of the provisions of this Directive, the Commission shall submit to the Council a report on the experience acquired by the Member States, particularly as regards the provisions referred to in paragraphs 1 and 2, possibly accompanied by proposals to amend those rules, on which the Council shall act by a qualified majority.
4. Pending implementation of the provisions referred to in paragraphs 1 and 2, the relevant national rules shall apply subject to the general rules laid down by the Treaty.
Article 14
The Annexes to this Directive shall be amended by the Council, acting by a qualified majority on a proposal from the Commission, with a view in particular to their adaptation to technological and scientific progress.
Article 15
In accordance with the procedure laid down in Article 17, the certificates or accompanying documents provided for by Community regulations for the transport of the animals referred to in Article 1 may be supplemented by an attestation from the competent authority within the meaning of Article 2 (6) of Directive 90/425/EEC certifying that the requirements of this Directive have been complied with.
Article 16
The rules regarding animal welfare during transport applicable to the movement of animals in certain parts of the territories referred to in Annex 1 to Directive 90/675/EEC, including, for the Kingdom of Spain, the Canary Islands, to take account of the natural constraints specific to those territories, in particular their remoteness from the mainland part of the Community territory, shall be adopted in accordance with the procedure laid down in Article 17, on the basis of the information laid down in the second paragraph.
To that end, by 1 July 1992 at the latest, the Member States concerned shall submit to the Commission the specific rules which will be complied with regarding animal welfare during transport when animals are moved within the regions concerned, taking into account the constraints specific to those territories.
Article 17
1. Where the procedure laid down in this Article is to be used, matters shall without delay be referred by the Chairman, either on his own initiative or at the request of the representative of a Member State, to the Standing Veterinary Committee (hereinafter called 'the Committee`) set up by Decision 68/361/EEC (1).
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft, within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
4. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission save where the Council has decided against the said measures by a simple majority.
Article 18
1. Member States shall take the appropriate specific measures to penalize any infringement of this Directive by natural or legal persons.
2. In the event of repeated infringements of this Directive, or of an infringement resulting in severe suffering to animals, a Member State may, without prejudice to the other sanctions imposed, take the measures necessary to correct the shortcomings noted.
Article 19
This Directive shall apply without prejudice to obligations arising from customs legislation.
Article 20
Directives 77/489/EEC and 81/389/EEC shall be repealed not later than the date referred to in Article 21.
Article 21
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Commission thereof.
2. When the Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
Article 22
This Directive is addressed to the Member States. | [
"UKSI19971480",
"UKSI19923304"
] |
31991L0659 | 1991 | Commission Directive 91/659/EEC of 3 December 1991 adapting to technical progress Annex I to Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (asbestos)
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (1), as last amended by Directive 91/339/EEC (2), and in particular Article 2a thereof, introduced by Directive 89/678/EEC (3),
Whereas the use of asbestos and even products containing it can, by releasing fibres, cause asbestosis, mesothelioma and lung cancer; whereas placing on the market and use should therefore be subject to the severest possible restrictions;
Whereas Council Directive 83/478/EEC (4) amending for the fifth time Directive 76/769/EEC specified that the crocidolite type of asbestos fibre and products containing it may, with three possible exceptions, no longer be placed on the market and used; whereas this same Directive established obligatory labelling provisions for all products containing asbestos fibres;
Whereas Council Directive 85/610/EEC (5) amending for the seventh time Directive 76/769/EEC specified that asbestos fibres can no longer be placed on the market and used in toys, materials and preparations applied by spraying, retail products in powder form, smoking accessories, catalytic heaters, paints and varnishes;
Whereas improved monitoring of the marketing and use of dangerous asbestos fibres is necessary to protect human heath, especially as there are for certain uses substitute products regarded, on the basis of risk analysis, as less dangerous;
Whereas a very effective way of protecting human health and the environment is to prohibit the use of certain fibres, such as those of amphibole asbestos, which according to some scientific sources are particularly dangerous; whereas for practical reasons such a prohibition can not for the time being be extended to naturally-occuring materials such as ores and sand containing asbestos fibres as natural impurities;
Whereas a fibre fixity test to assess the dangers posed by particular asbestos-containing products is not yet widely available; whereas, notwithstanding this, products should be promoted which reduce the overall risk to man and the environment;
Whereas Council Directive 91/382/EEC (6) amends Directive 83/477/EEC on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC);
Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaption to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in Dangerous Substances and Preparations,
Article 1
Annex I to Directive 76/769/EEC is hereby adapted to technical progress as set out in the Annex hereto.
Article 2
1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 1 January 1993 and shall forthwith inform the Commission thereof. They shall apply these provisions as from 1 July 1993.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. Member States shall communicate to the Commission no later than 18 months after the date of its adoption the text of the basic provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19923067",
"UKSI19871979",
"UKSI19852042",
"UKSI19841802"
] |
31991L0662 | 1991 | Commission Directive 91/662/EEC of 6 December 1991 adapting to technical progress Council Directive 74/297/EEC in respect of the behaviour of the steering wheel and column in an impact
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 74/297/EEC of 4 June 1974 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (the behaviour of the steering mechanism in the event of an impact) (1), and in particular Article 5 thereof,
Whereas, in view of experience gained and of the state of the art, it is now appropriate, in the case of a frontal impact, to improve protection offered to the driver by controlling the behaviour of the sterring wheel and mechanism which is the aim of Directive 74/297/EEC, by aligning it with the latest developments in the relevant Regulation of the United Nations Economic Commission for Europe and by the introduction of some further improvements;
Whereas, in view of experience gained from accidents indicating that the steering wheel should be soft to protect the driver's face from serious injury, further modifications to this Directive should be introduced for this purpose; whereas, as several proposals for a test method are available, the Commission should bring forward a further proposal to the Committee for Adaptation to Technical Progress by 31 December 1991;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on Motor Vehicles,
Article 1
The Annexes to Directive 74/297/EEC are hereby amended in accordance with the Annexes to this Directive.
Article 2
1. With effect from 1 October 1992 no Member State may
(a) - refuse, in respect of a type of vehicle, to grant EC type-approval, or to issue the copy of the certificate provided for in the last indent of Article 10 (1) of Council Directive 70/156/EEC (2), or to grant national type-approval, or
- prohibit the entry into service of vehicles,
on grounds relating to their steering mechanism if this has been approved in accordance with Directive 74/297/EEC as amended by this Directive;
(b)
- refuse to grant EC type-approval in respect of a type of steering control intended for installation in a vehicle or vehicles, or
- prohibit the placing on the market of steering controls intended for installation in a vehicle or vehicles
if the said steering control complies with the requirements of Directive 74/297/EEC as amended by this Directive.
2. With effect from 1 October 1996, in respect of motor vehicles of category M1 which are not forward control, Member States:
- shall no longer issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC, and
- may refuse to grant national type-approval
on grounds relating to the steering mechanism if this does not comply with the requirements of Directive 74/297/EEC as amended by this Directive.
3. With effect from 1 October 1995, in respect of forward-control motor vehicles of category M1 and all N1 motor vehicles with a permissible maximum mass not exceeding 1 500 kilograms, Member States:
- shall no longer issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC, and
- may refuse to grant national type-approval
on grounds relating to the steering mechanism if this does not comply with the requirements of Directive 74/297/EEC as amended by this Directive.
4. With effect from 1 October 1996, in respect of types of steering control, Member States:
- shall no longer issue the copy of the certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC, and
- may refuse to grant national type-approval
on grounds relating to steering controls if these steering controls do not comply with the requirements of paragraphs 5.2, 5.3 and 5.4 of Annex I to Directive 74/297/EEC as amended by this Directive.
5. With effect from 1 October 1996 Member States may prohibit the first entry into service of vehicles in which the steering mechanisms do not comply with the requirements of Directive 74/297/EEC, as amended by this Directive.
However, this shall not apply until 1 October 1997:
- to a forward-control vehicle of category M1, or
- to a vehicle of category N1 with a maximum permissible mass not exceeding 1 500 kilograms, or
- in the case of a vehicle of category M1 other than a forward-control vehicle, with respect to the requirements laid down in paragraph 5.1 of Annex I (maximum vertical displacement of the steering column).
6. With effect from 1 October 1995 Member States may prohibit the placing on the market of steering controls intended for the installation in a vehicle or vehicles if these steering controls do not comply with the requirements laid down in paragraphs 5.2, 5.3 and 5.4 of Annex I to Directive 74/297/EEC, as amended by this Directive.
Article 3
1. Member States shall bring into force the legislative, regulatory and administrative provisions necessary in order to comply with this Directive before 1 October 1992 and shall forthwith inform the Commission thereof.
When the Member States adopt these provisions these shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. Member States shall ensure that the terms of the main provisions of national law which they adopt in the field covered by this Directive are communicated to the Commission.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19922154"
] |
31991L0663 | 1991 | Commission Directive 91/663/EEC of 10 December 1991 adapting to technical progress Council Directive 76/756/EEC relating to the installation of lighting and light-signalling devices on motor vehicles and their trailers
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100A thereof,
Having regard to Council Directive 70/156/EEC of 6 February 1970 relating to the type-approval of motor vehicles and their trailers (1), as last amended by Directive 87/403/EEC of 25 June 1987 (2), and in particular Article 11 thereof,
Having regard to Council Directive 76/756/EEC of 27 July 1976 relating to the installation of lighting and light-signalling devices on motor vehicles and their trailers (3), as amended by Directives: 80/233/EEC of 21 November 1979 (4), 82/244/EEC of 17 March 1982 (5), 83/276/EEC of 26 May 1983 (6), 84/8/EEC of 14 December 1983 (7) and 89/278/EEC of 28 March 1989 (8),
Whereas for clarity it is now necessary to produce a consolidation of these Directives;
Whereas in the light of technical progress it is now possible to introduce further amendments, namely the colour of headlights will be required to be white only, side-marker lamps will be specified for certain vehicles and the requirement for lamps on movable components and other matters of detailed drafting can be clarified;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives on the Removal of Technical Barriers to Trade in the Motor Vehicles Sector,
Article 1
Directive 76/756/EEC is amended as follows:
1. the Articles are replaced by the following Articles to this Directive;
2. the Annexes are replaced by the Annexes to this Directive.
Article 2
For the purposes of this Directive, 'vehicle` means any vehicle to which Council Directive 70/156/EEC applies.
Article 3
1. With effect from 1 January 1993, no Member State may:
- refuse, in respect of a type of vehicle, to grant EC type-approval, to issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC, or to grant national type-approval, or
- prohibit the entry into service of vehicles
on grounds relating to the installation of the lighting and light-signalling devices on this type of vehicle or on these vehicles if these devices are installed in accordance with the requirements of this Directive.
2. With effect from 1 October 1993, Member States:
- shall no longer issue the document referred to in the last indent of Article 10 (1) of Directive 70/156/EEC, and
- may refuse to grant national type-approval
in respect of a type of vehicle on which the installation of the lighting and light-signalling devices is not in accordance with the requirements of this Directive.
3. With effect from 1 October 1994, Member States may prohibit the first entry into service of vehicles on which the installation of these devices is not in accordance with the requirements of this Directive.
Article 4
A Member State which has granted EC type-approval shall take the necessary measures to ensure that it is informed of any modification to any parts or characteristics referred to in item 1.1 of Annex I. The competent authorities of that Member State shall determine whether further tests should be carried out on the modified vehicle type and a fresh report drawn up. Where such tests reveal failure to comply with the requirements of this Directive, the modification shall not be approved.
Article 5
Any amendments necessary in order to adapt the content of the Annexes to this Directive to take account of technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC.
Article 6
1. Member States shall bring into force the legislative, regulatory and administrative provisions necessary in order to comply with this Directive before 1 January 1993 and shall forthwith inform the Commission thereof.
2. When the Member States adopt these provisions they shall make a reference to this Directive in their official publication. The form of this reference shall be determined by the Member States.
3. Member States shall ensure that the terms of the main provisions of national law which they adopt in the field covered by this Directive are communicated to the Commission.
Article 7
This Directive is addressed to the Member States. | [
"UKSI19922154"
] |
31991L0687 | 1991 | Council Directive 91/687/EEC of 11 December 1991 amending Directives 64/432/EEC, 72/461/EEC and 80/215/EEC as regards certain measures relating to swinefever
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Comission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Council Decision 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (4), as last amended by Directive 91/499/EEC (5), defines in particular the conditions which must be statisfied, as regards swine-fever, by live pigs intended for intra-Community trade;
Whereas Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat (6), as last amended by Directive 91/266/EEC (7), defines the conditions which must be satisfied as regards classical swine-fever by fresh pigmeat intended for intra-Community trade;
Whereas Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat products (8), as last amended by Directive 89/662/EEC (9), defines in particular the conditions which must be satisfied as regards classical swine-fever for meat products intended for intra-Community trade;
Whereas the measures applied to eradicate classical swine-fever have gradually improved the health status of the pig population in the territory of the Community;
Whereas one of the given objectives, namely to keep the territory of the Community free from classical swine-fever, has been attained in large areas and it is necessary to take this situation into account and consequently to amend Directives 64/432/EEC, 72/461/EEC and 80/215/EEC;
Whereas, in this context, it is appropriate not to extend the type of guarantees laid down in Article 4b of Directive 64/432/EEC and in Article 13a of Directive 72/461/EEC, and to discontinue the measures laid down in Article 10 of Directive 80/215/EEC,
Article 1
Directive 64/432/EEC is hereby amended as follows:
(1) in Article 2:
(a) the words 'swine-fever` in point (j) of (ii) shall be deleted;
(b) points (p), (q) and (r) shall be deleted;
(2) in Article 3:
(a) the words 'swine-fever` in the introductory words of paragraph 2 (b) shall be deleted;
(b) the words 'swine-fever` in paragraph 2 (b) (i) shall be deleted;
(c) paragraph 2 (b) (ii) shall be deleted;
(d) the words 'swine-fever` in paragraph 2 (c) (ii) shall be deleted;
(e) the first sentence of paragraph 4 shall be replaced by the following:
'4. Swine for breeding and production must, moreover, come from brucellosis-free stock.`;
(3) in Article 4b, '31 December 1991` shall be replaced by '1 July 1992`;
(4) with effect from 1 July 1992, Article 4b shall be replaced by the following:
'Article 4b In addition to the measures provided for in this Directive concerning classical swine-fever, each Member State shall ensure that pigs sent from its territory to that of another Member State shall not come from a holding or an area which is subject to restrictions for classical swine-fever in conformity with Council Decision 80/217/EEC of 22 January 1980 introducing Community measures for the control of classical swine-fever (*).
(*) OJ N° L 47, 21. 2. 1980, p. 11.`;
(5) in Annex F, Form III, V, point (c) shall be deleted. Points '(d), (e), (f), and (g)` shall become '(c), (d), (e) and (f)`.
Article 2
Directive 72/461/EEC is hereby amended as follows:
(1) in the first subparagraph of Article 13 a (3), '31 December 1991` shall be replaced by '1 July 1992`;
(2) in Article 3, the following point shall be added:
'(e) The meat shall not be subject of animal health restrictive measures pursuant to the provisions of Council Directive 80/217/EEC of 22 January 1980 introducing Community measures for the control of classical swine-fever (*).
(*) OJ N° L 47, 21. 2. 1980, p. 11.`
Article 3
Article 10 of Directive 80/215/EEC shall be deleted.
Article 4
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1 (3) and Article 2 (1) of this Directive not later than 1 January 1992 and, as regards compliance with the remaining provisions thereof, not later than 1 July 1992. They shall forthwith inform the Commission thereof.
When these measures are adopted by the Member States, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 5
This Directive is addressed to the Member States. | [
"UKSI19770944",
"UKSI19800014"
] |
31991L0688 | 1991 | Council Directive 91/688/EEC of 11 December 1991 amending Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine, fresh meat or meat products from third countries
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Directive 72/462/EEC (4), as last amended by Directive 91/266/EEC (5), defines in particular the conditions which must be satisfied as regards classical swine-fever upon importation of live pigs, fresh pig meat and meat products from third countries;
Whereas, given that the health situation within the Community in respect of classical swine-fever has improved and systematic vaccination against the disease has been discontinued, it is appropriate to amend the conditions laid down for importation of live pigs, fresh pig meat and meat products,
Article 1
Directive 72/462/EEC is hereby amended as follows:
1. the following paragraphs shall be added to Article 6:
'4. In respect of classical swine-fever, pigs must come from the territory of a third country which:
- has been free from classical swine-fever for at least 12 months,
- has not permitted vaccination for the preceding 12 months,
- does not allow on its territory pigs which have been vaccinated less than 12 months previously.
5. By way of derogation from paragraph 4, it may be decided, in accordance with the procedure laid down in Article 29, to authorize the importation of pigs coming from a part of the territory of a third country provided that vaccination against classical swine-fever is prohibited throughout the entire territory of that country and that the part of the territory of the third country concerned fulfils the conditions laid down in paragraph 4.
6. By way of derogation from paragraph 4, in the event of classical swine-fever occurring in a third country which fulfils the conditions of paragraph 4, it may be decided, in accordance with the procedure laid down in Article 29, that the period of 12 months referred to in the first indent of paragraph 4 may be reduced to six months if:
(a) an outbreak or a number of epizootiologically interrelated outbreaks occur within a geographical limited area; and (b) the outbreak or outbreaks have been stamped out, within a period of three months and without recourse to vaccination.`;
2. the following subparagraph shall be added to Article 14 (2):
'(c) in which no classical swine-fever has been detected for at least the preceding 12 months, vaccination against classical swine-fever has not been authorized for at least the preceding 12 months and no pigs have been vaccinated against classical swine-fever in the preceding 12 months.`;
3. the following sentence shall be added to Article 15:
'In accordance with the procedure laid down in Article 29, it may be decided to derogate from Article 14 (2) (c).`
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1992. They shall forthwith inform the Commission thereof.
When these measures are adopted by the Member States, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19770944"
] |
31991L0689 | 1991 | Council Directive 91/689/EEC of 12 December 1991 on hazardous waste
Having regard to the Treaty establishing the European Economic Community, and in particluar Article 103s thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Council Directive 78/319/EEC of 20 March 1978 on toxic and dangerous waste (4), established Community rules on the disposal of dangerous waste; whereas in order to take account of experience gained in the implementation of that Directive by the Member States, it is necessary to amend the rules and to replace Directive 78/319/EEC by this Directive;
Whereas the Council resolution of 7 May 1990 on waste policy (5) and the action programme of the European Communities on the environment, which was the subject of the resolution of the Council of the European Communities and of the representatives of the Government of the Member States, meeting within the Council, of 19 October 1987 on the continuation and implementation of a European Community policy and action programme on the environment (1987 to 1992) (6), envisage Community measures to improve the conditions under which hazardous wastes are disposed of and managed;
Whereas the general rules applying to waste management which are laid down by Council Directive 75/442/EEC of 15 July 1975 on waste (7), as amended by Directive 91/156/EEC (8), also apply to the management of hazardous waste;
Whereas the correct management of hazardous waste necessitates additional, more stringent rules to take account of the special nature of such waste;
Whereas it is necessary, in order to improve the effectiveness of the management of hazardous waste in the Community, to use a precise and uniform definition of hazardous waste based on experience;
Whereas it is necessary to ensure that disposal and recovery of hazardous waste is monitored in the fullest manner possible;
Whereas it must be possible rapidly to adapt the provisions of this Directive to scientific and technical progress; whereas the Committee set up by Directive 75/442/EEC must also empowered to adapt the provisions of this Directive to such progress,
Article 1
1. The object of this Directive, drawn up pursuant to Article 2 (2) of Directive 75/442/EEC, is to approximate the laws of the Member States on the controlled management of hazardous waste.
2. Subject ot this Directive, Directive 75/442/EEC shall apply to hazardous waste.
3. The definition of 'waste` and of the other terms used in this Directive shall be those in Directive 75/442/EEC.
4. For the purpose of this Directive 'hazardous waste` means:
- wastes featuring on a list to be drawn up in accordance with the procedure laid down in Article 18 of Directive 75/442/EEC on the basis of Annexes I and II to this Directive, not later than six months before the date of implementation of this Directive. These wastes must have one or more of the properties listed in Annex III. The list shall take into account the origin and composition of the waste and, where necessary, limit values of concentration. This list shall be periodically reviewed and if necessary by the same procedure,
- any other waste which is considered by a Member State to display any of the properties listed in Annex III. Such cases shall be notified to the Commission and reviewed in accordance with the procedure laid down in Article 18 of Directive 75/442/EEC with a view to adaptation of the list.
5. Domestic waste shall be exempted from the provisions of this Directive. The Council shall establish, upon a proposal from the Commission, specific rules taking into consideration the particular nature of domestic waste not later than the end of 1992.
Article 2
1. Member States shall take the necessary measures to require that on every site where tipping (discharge) of hazardous waste takes place the waste is recorded and identified.
2. Member States shall take the necessary measures to require that establishment and undertaking which dispose of, recover, collect or transport hazardous waste do not mix different categories of hazardous waste or mix hazardous waste with non-hazardous waste.
3. By way of derogation from paragraph 2, the mixing of hazardous waste with other hazardous waste or with other waste, substances or materials may be permitted only where the conditions laid down in Article 4 of Directive 75/442/EEC are complied with and in particular for the purpose of improving safety during disposal or recovery. Such an operation shall be subject to the permit requirement imposed in Articles 9, 10 and 11 of Directive 75/442/EEC.
4. Where waste is already mixed with other waste, substances or materials, separation must be effected, where technically and economically feasible, and where necessary in order to comply with Article 4 of Directive 75/442/EEC.
Article 3
1. The derogation referred to in Article 11 (1) (a) of Directive 75/442/EEC from the permit requirement for establishments or undertakings which carry out their own waste disposal shall not apply to hazardous waste covered by this Directive.
2. In accordance with Article 11 (1) (b) of Directive 75/442/EEC, a Member State may waive Article 10 of that Directive for establishments or undertakings which recover waste covered by this Directive:
- if the Member State adopts general rules listing the type and quantity of waste and laying down specific conditions (limit values for the content of hazardous substances in the waste, emission limit values, type of activity) and other necessary requirements for carrying out different forms of recovery, and - if the types or quantities of waste and methods of recovery are such that the conditions laid down in Article 4 of Directive 75/442/EEC are complied with.
3. The establishments or undertankings referred to in paragraph 2 shall be registered with the competent authorities.
4. If a Member State intends to make use of the provisions of paragraph 2, the rules referred to in that paragraph shall be sent to the Commission not later than three months prior to their coming into force. The Commission shall consult the Member States. In the light of these consultations the Commission shall propose that the rules be finally agreed upon in accordance with the procedure laid down in Article 18 of Directive 75/442/EEC.
Article 4
1. Article 13 of Directive 75/442/EEC shall also apply to producers of hazardous waste.
2. Article 14 of Directive 75/442/EEC shall also apply to producers of hazardous waste and to all establishments and undertakings transporting hazardous waste.
3. The records referred to in Article 14 of Directive 75/442/EEC must be preserved for at least three years except in the case of establishments and undertakings transporting hazardous waste which must keep such records for at least 12 months. Documentary evidence that the management operations have been carried out must be supplied at the request of the competent authorities or of a previous holder.
Article 5
1. Member States shall take the necessary measures to ensure that, in the course of collection, transport and temporary storage, waste is properly packaged and labelled in accordance with the international and Community standards in force.
2. In the case of hazardous waste, inspections concerning collection and transport operations made on the basis of Article 13 of Directive 75/442/EEC shall cover more particularly the origin and destination of such waste.
3. Where hazardous waste is transferred, it shall be accompanied by an identification form containing the details specified in Section A of Annex I to Council Directive 84/631/EEC of 6 December 1984 on the supervision and control within the European Community of the transfrontier shipment of hazardous waste (1), as last amended by Directive 86/279/EEC (2).
Article 6
1. As provided in Article 7 of Directive 75/442/EEC, the competent authorities shall draw up, either separately or in the framework of their general waste management plans, plans for the management of hazardous waste and shall make these plans public.
2. The Commission shall compare these plans, and in particular the methods of disposal and recovery. It shall make this information available to the competent authorities of the Member States which ask for it.
Article 7
In cases of emergency or grave danger, Member States shall take all necessary steps, including, where appropriate, temporary derogations from this Directive, to ensure that hazardous waste is so dealt with as not to constitute a threat to the population or the environment. The Member State shall inform the Commission of any such derogations.
Article 8
1. In the context of the report provided for in Article 16 (1) of Directive 75/442/EEC, and on the basis of a questionnaire drawn up in accordance with that Article, the Member States shall send the Commission a report on the implementation of this Directive.
2. In addition to the consolidated report referred to in Article 16 (2) of Directive 75/442/EEC, the Commission shall report to the European Parliament and the Council every three years on the implementation of this Directive.
3. In addition, by 12 December 1994, the Member States shall send the Commission the following information for every establishment or undertaking which carries out disposal and/or recovery of hazardous waste principally on behalf of third parties and which is likely to form part of the integrated network referred to in Article of Directive 75/442/EEC:
- name and address,
- the method used to treat waste,
- the types and quantities of waste which can be treated.
Once a year, Member States shall inform the Commission of any changes in this information.
The Commission shall make this information available on request to the competent authorities in the Member States.
The format in which this information will be supplied to the Commission shall be agreed upon in accordance with the procedure laid down in Article 18 of Directive 75/442/EEC.
Article 9
The amendments necessary for adapting the Annexes to this Directive to scientific and technical progress and for revising the list of wastes referred to in Article 1 (4) shall be adopted in accordance with the procedure laid down in Article 18 of Directive 74/442/EEC.
Article 10
1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 12 December 1993. They shall forthwith inform the Comission thereof.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
Article 11
Directive 78/319/EEC is hereby repealed with effect from 12 December 1993.
Article 12
This Directive is addressed to the Member States. | [
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"UKSI19962019"
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31991L0676 | 1991 | Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources
Having regard to the Treaty establishing the European Economic Community, and in particular Article 130s thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the nitrate content of water in some areas of Member States is increasing and is already high as compared with standards laid down in Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (4), as amended by Directive 79/869/EEC (5), and Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption (6), as amended by the 1985 Act of Accession;
Whereas the fourth programme of action of the European Economic Communities on the environment (7) indicated that the Commission intended to make a proposal for a Directive on the control and reduction of water pollution resulting from the spreading or discharge of livestock effluents and the excessive use of fertilizers;
Whereas the reform of the common agricultural policy set out in the Commission's green paper 'Perspectives for the common agricultural policy` indicated that, while the use of nitrogen-containing fertilizers and manures is necessary for Community agriculture, excessive use of fertilizers constitutes an environmental risk, that common action is needed to control the problem arising from intensive livestock production and that agricultural policy must take greater account of environmental policy;
Whereas the Council resolution of 28 June 1988 of the protection of the North Sea and of other waters in the Community (8) invites the Commission to submit proposals for measures at Community level;
Whereas the main cause of pollution from diffuse sources affecting the Community's waters in nitrates from agricultural sources;
Whereas it is therefore necessary, in order to protect human health and living resources and aquatic ecosystems and to safeguard other legitimate uses of water, to reduce water pollution caused or induced by nitrates from agricultural sources and to prevent further such pollution; whereas for this purpose it is important to take measures concerning the storage and the application on land of all nitrogen compounds and concerning certain land management practices;
Whereas since pollution of water due to nitrates on one Member State can influence waters in other Member States, action at Community level in accordance with Article 130r is therefore necessary;
Whereas, by encouraging good agricultural practices, Member States can provide all waters with a general level of protection against pollution in the future;
Whereas certain zones, draining into waters vulnerable to pollution from nitrogen compounds, require special protection;
Whereas it is necessary for Member States to identify vulnerable zones and to establish and implement action programmes in order to reduce water pollution from nitrogen compounds in vulnerable zones;
Whereas such action programmes should include measures to limit the land-application of all nitrogen-containing fertilizers and in particular to set specific limits for the application of livestock manure;
Whereas it is necessary to monitor waters and to apply reference methods of measurement for nitrogen compounds to ensure that measures are effective;
Whereas it is recognized that the hydrogeology in certain Member States is such that it may be many years before protection measures lead to improvements in water quality;
Whereas a Committee should be established to assist the Commission on matters relating to the implementation of this Directive and to its adaptation to scientific and technical progress;
Whereas Member States should establish and present to the Commission reports on the implementation of this Directive;
Whereas the Commission should report regularly on the implementation of this Directive by the Member States,
Article 1
This Directive has the objective of:
- reducing water pollution caused or induced by nitrates from agricultural sources and - preventing further such pollution.
Article 2
For the purpose of this Directive:
(a) 'groundwater`: means all water which is below the surface of the ground in the saturation zone and in direct contact with the ground or subsoil;
(b) 'freshwater`: means naturally occurring water having a low concentration of salts, which is often acceptable as suitable for abstraction and treatment to produce drinking water;
(c) 'nitrogen compound`: means any nitrogen-containing substance except for gaseous molecular nitrogen;
(d) 'livestock`: means all animals kept for use or profit;
(e) 'fertilizer`: means any substance containing a nitrogen compound or nitrogen compounds utilized on land to enhance growth of vegetation; it may include livestock manure, the residues from fish farms and sewage sludge;
(f) 'chemical fertilizer`: means any fertilizer which is manufactured by an industrial process;
(g) 'livestock manure`: means waste products excreted by livestock or a mixture of litter and waste products excreted by livestock, even in processed form;
(h) 'land application`: means the addition of materials to land whether by spreading on the surface of the land, injection into the land, placing below the surface of the land or mixing with the surface layers of the land;
(i) 'eutrophication`: means the enrichment of water by nitrogen compounds, causing an accelerated growth of algae and higher forms of plant life to produce an undesirable disturbance to the balance of organisms present in the water and to the quality of the water concerned;
(j) 'pollution`: means the discharge, directly or indirectly, of nitrogen compounds from agricultural sources into the aquatic environment, the results of which are such as to cause hazards to human health, harm to living resources and to aquatic ecosystems, damage to amenities or interference with other legitimate uses of water;
(k) 'vulnerable zone`: means an area of land designated according to Article 3 (2).
Article 3
1. Waters affected by pollution and waters which could be affected by pollution if action pursuant Article 5 is not taken shall be identified by the Member States in accordance with the criteria set out in Annex I.
2. Member States shall, within a two-year period following the notification of this Directive, designate as vulnerable zones all known areas of land in their territories which drain into the waters identified according to paragraph 1 and which contribute to pollution. They shall notify the Commission of this initial designation within six months.
3. When any waters identified by a Member State in accordance with paragraph 1 are affected by pollution from waters from another Member State draining directly or indirectly in to them, the Member States whose waters are affected may notify the other Member States and the Commission of the relevant facts.
The Member States concerned shall organize, where appropriate with the Commission, the concertation necessary to identify the sources in question and the measures to be taken to protect the waters that are affected in order to ensure conformity with this Directive.
4. Member States shall review if necessary revise or add to the designation of vulnerable zones as appropriate, and at last every four years, to take into account changes and factors unforeseen at the time of the previous designation. They shall notify the Commission of any revision or addition to the designations within six months.
5. Member States shall be exempt from the obligation to identify specific vulnerable zones, if they establish and apply action programmes referred to in Article 5 in accordance with this Directive throughout their national territory.
Article 4
1. With the aim of providing for all waters a general level of protection against pollution, Member States shall, within a two-year period following the notification of this Directive:
(a) establish a code or codes of good agricultural practice, to be implemented by farmers on a voluntary basis, which should contain provisions covering at least the items mentioned in Annex II A;
(b) set up where necessary a programme, including the provision of training and information for farmers, promoting the application of the code(s) of good agricultural practice.
2. Member States shall submit to the Commission details of their codes of good agricultural practice and the Commission shall include information on these codes in the report referred to in Article 11. In the light of the information received, the Commission may, if it considers it necessary, make appropriate proposals to the Council.
Article 5
1. Within a two-year period following the initial designation referred to in Article 3 (2) or within one year of each additional designation referred to in Article 3 (4), Member States shall, for the purpose of realizing the objectives specified in Article 1, establish action programmes in respect of designated vulnerable zones.
2. An action programme may relate to all vulnerable zones in the territory of a Member State or, where the Member State considers it appropriate, different programmes may be established for different vulnerable zones or parts of zones.
3. Action programmes shall take into account:
(a) available scientific and technical data, mainly with reference to respective nitrogen contributions originating from agricultural and other sources;
(b) environmental conditions in the relevant regions of the Member State concerned.
4. Action programmes shall be implemented within four years of their establishment and shall consist of the following mandatory measures:
(a) the measures in Annex III;
(b) those measures which Member States have prescribed in the code(s) of good agricultural practice established in accordance with Article 4, except those which have been superseded by the measures in Annex III.
5. Member States shall moreover take, in the framework of the action programmes, such additional measures or reinforced actions as they consider necessary if, at the outset or in the light of experience gained in implementing the action programmes, it becomes apparent that the measures referred to in paragraph 4 will not be sufficient for achieving the objectives specified in Article 1. In selecting these measures or actions, Member States shall take into account their effectiveness and their cost relative to other possible preventive measures.
6. Member States shall draw up and implement suitable monitoring programmes to assess the effectiveness of action programmes established pursuant to this Article.
Member States which apply Article 5 throughout their national territory shall monitor the nitrate content of waters (surface waters and groundwater) at selected measuring points which make it possible to establish the extent of nitrate pollution in the waters from agricultural sources.
7. Member States shall review and if necessary revise their action programmes, including any additional measures taken pursuant to paragraph 5, at least every four years. They shall inform the Commission of any changes to the action programmes.
Article 6
1. For the purpose of designating and revising the designation of vulnerable zones, Member States shall:
(a) within two years of notification of the Directive, monitor the nitrate concentration in freshwaters over a period of one year:
(i) at surface water sampling stations, laid down in Article 5 (4) of Directive 75/440/EEC and/or at other sampling stations which are representative of surface waters of Member States, at least monthly and more frequently during flood periods;
(ii) at sampling stations which are representative of the groundwater aquifers of Member States, at regular intervals and taking into account the provisions of Directive 80/778/EEC;
(b) repeat the monitoring programme outlined in (a) at least every four years, except for those sampling stations where the nitrate concentration in all previous samples has been below 25 mg/l and no new factor likely to increase the nitrage content has appeared, in which case the monitoring programme need be repeated only every eight years;
(c) review the eutrophic state of their fresh surface waters, estuarial and coastal waters every four years.
2. The reference methods of measurement set out in Annex IV shall be used.
Article 7
Guidelines for the monitoring referred to in Article 5 and 6 may be drawn up in accordance with the procedure laid down in Article 9.
Article 8
The Annexes to this Directive may be adapted to scientific and technical progress in accordance with the procedure laid down in Article 9.
Article 9
1. The Commission shall be assisted by a Committee composed of the representative of the Member States and chaired by the representative of the Commission.
2. The representative of the Commission shall submit to the Commission a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the EEC Treaty in the case of decisions which the Council is required to adopt a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
(c) If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority.
Article 10
1. Member States shall, in respect of the four-year period following the notification of this Directive and in respect of each subsequent four-year period, submit a report to the Commission containing the information outlined in Annex V.
2. A report pursuant to this Article shall be submitted to the Commission within six months of the end of the period to which it relates.
Article 11
On the basis of the information received pursuant to Article 10, the Commission shall publish summary reports within six months of receiving the reports from Member States and shall communicate them to the European Parliament and to the Council. In the light of the implementation of the Directive, and in particular the provisions of Annex III, the Commission shall submit to the Council by 1 January 1998 a report accompanied where appropriate by proposals for revision of this Directive.
Article 12
1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within two years of its notification (1). They shall forthwith inform the Commission thereof.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
Article 13
This Directive is addressed to the Member States. | [
"UKSI19960888",
"UKSI20022614"
] |
31991L0671 | 1991 | Council Directive 91/671/EEC of 16 December 1991 on the approximation of the laws of the Member States relating to compulsory use of safety belts in vehicles of less than 3,5 tonnes
Having regard to the Treaty establishing the European Economic Community, and in particular Article 75 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the national laws on compulsory use of safety belts differ widely from one Member State to another; whereas it is therefore necessary to harmonize that compulsory use;
Whereas the obligation to use safety belts should be harmonized in vehicles of less than 3,5 tonnes in order to guarantee road users a greater degree of safety;
Whereas Directives 76/115/EEC (4) and 77/541/EEC (5) concern the technical requirements relating to safety belts with which motor vehicles must comply, but not the use of safety belts;
Whereas in the resolution of 19 December 1984 (6), the Council and the Representatives of the Governments of the Member States, meeting within the Council, undertook to ensure the rapid adoption of road safety measures, and invited the Commission to submit proposals;
Whereas resolutions of the European Parliament on road safety (7) have recommanded that the wearing of safety belts by all passengers, including children, on all roads and in all seats in passenger vehicles (except public service vehicles), should be compulsory;
Whereas provision should be made for the compulsory use of child restraint systems on seats fitted with safety belts;
Whereas, pending harmonized Community standards for child restraint systems, those standards which correspond to Member States' national requirements must be recognized throughout the Member States;
Whereas studies have also shown that rear seats are almost as hazardous as front seats for unbelted passengers and that rear-seat passengers not wearing belts increase the risk of injuries to front seat passengers; whereas deaths and injuries could thus be further reduced if the wearing of belts in rear seats was made compulsory;
Whereas the fixing of the date of entry into force of the measures referred to in this Directive should allow time for the drafting of the implementing provisions required, particularly in those Member States where as yet no provisions on this matter exist,
Article 1
1. This Directive shall apply to all motor vehicles in categories M1, M2 (except for rear seats and vehicles of a maximum permissible weight exceeding 3,5 tonnes and those which include places specially designed for standing passengers) and N1 (except for rear seats), as defined in Annex I to Directive 70/156/EEC (1), intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h.
2. for the purposes of this Directive:
1. 'safety belt (seat belt, belt)` means an assembly of straps with a securing buckle, adjusting devices and attachments which is capable of being anchored inside a power-driven vehicle and is designed to diminish the risk of injury to its wearer, in the event of collision or of abrupt vehicle deceleration, by limiting the mobility of the wearer's body. Such an assembly is generally referred to as a 'belt assembly`, a term also embracing any devices for energy absorption or belt retraction;
2. 'restraint system` means a system combining a seat, fixed to the structure of the vehicle by appropriate means and a safety belt for which at least one anchorage point is located on the seat structure;
3. 'seat` means a structure which may or may not be integral with the vehicle structure complete with trim, intended to seat one adult person. The term covers both an individual seat and part of a bench seat intended to seat one person.
Article 2
Member States shall ensure that the driver and passengers occupying the seats of vehicles on the road as referred to in Article 1 wear safety belts or are restrained by an approved restraint system provided the occupied seats are fitted with such equipment. Rear-seat occupants must use equipped seats before others.
Member States shall ensure that children under 12 years of age and who are less than 150 cm tall, travelling in such vehicles and occupying belted seats, are restrained by an approved restraint system suitable for the child's height and weight. These seats must be occupied before the others.
The use of a restraint system approved by the competent authority of a Member State shall be permitted by the other Member States.
Article 3
The provisions of this Directive shall also apply to drivers and passengers of vehicles being used on the road in the Community which are registered in a third country.
Article 4
1. By way of derogation from the second paragraph of Article 2, Member States may, on their national territory, permit children aged three years and over occupying the seats of vehicles referred to in Article 1 to be restrained by a safety belt or other restraint system approved for adult use.
2. Member States shall also, on their territory and under conditions specified in their national law, allow that children under three years of age occupying rear seats need not be restrained by a restraint system suitable for their height and weight if such children are transported in a vehicle where such a system is unavailable.
Article 5
Persons provided by the competent authorities with an exemption certificate for serious medical reasons shall be exempt from the obligations laid down in Article 2. Any medical certificate issued by the competent authorities in one Member State shall also be valid in any other Member State; the medical certificate must indicate its period of validity and be shown to all authorized persons upon request in accordance with the relevant provisions in force in each Member State. It must bear the following symbol:
>REFERENCE TO A FILM>
Article 6
Member States may, with the Commission's agreement, grant exemptions other than those laid down in Article 5, in order to:
- take account of specific physical conditions, or particular circumstances of limited duration,
- allow certain types of occupation to be carried out effectively,
- ensure that the police, security services or emergency services can perform their duties properly.
Article 7
The Commission shall, by 1 August 1994, submit a report on the implementation of this Directive for the particular purpose of establishing whether or not more stringent safety measures and much closer harmonization are needed. If appropriate, the report shall be accompanied by proposals, on which the Council shall act by a qualified majority at the earliest opportunity.
Article 8
1. After consulting the Commission, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Commission thereof.
2. When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Member States shall communicate to the Commission the texts of the main provision of national law, which they adopt in the field governed by this Directive.
Article 9
This Directive is addressed to the Member States. | [
"UKSI19930176",
"UKSI19930031"
] |
31991L0670 | 1991 | Council Directive 91/670/EEC of 16 December 1991 on mutual acceptance of personnel licences for the exercise of functions in civil aviation
Having regard to the Treaty establishing the European Economic Community, and in particular Article 84 (2) thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the existence in sufficient numbers of cockpit personnel holding the necessary qualifications and licences is vital for the smooth and safe running of air transport services;
Whereas also the completion of the internal market by the end of 1992 requires the existence of an efficient air transport system in order to facilitate the movement of persons within the Community;
Whereas air transport is a highly dynamic and rapidly developing sector of a particularly international character; whereas, therefore, the balance between supply and demand in personnel can be maintained more efficiently at the Community than the national level;
Whereas it is therefore essential that the common transport policy in the field of civil aviation be extended to facilitate the movement of cockpit personnel within the Community;
Whereas the requirements for licences of cockpit personnel differ between Member States;
Whereas the qualifications required for licences are not at present laid down by the Community; whereas Member States therefore retain the option of fixing the level of such qualifications with a view to guaranteeing the safety of services provided by aircraft registered on their territority; whereas they may not, without infringing their obligations laid down in the Treaty, require a national of a Member State to obtain those qualifications, which in general they determine solely by reference to their own national education and training systems, where the person concerned has already acquired those qualifications in another Member State;
Whereas in order to facilitate compliance with Treaty obligations and to ensure the mobility of cockpit personnel, a Community procedure should be introduced for the acceptance of licences and qualifications of such personnel;
Whereas the recognition of private pilots' licences can already be established in all Member States;
Whereas, if in order to be permitted to operate aircraft registered in a Member State other than that where they obtained their licence, professional pilots have to be subjected to additional tests, they should be offered the possibility of sitting such tests as soon as possible;
Whereas training facilities available in Member States are not always commensurate with demand; whereas in conformity with Article 7 of the Treaty, Member States must admit nationals of other Member States to public and private training establishments and professional examinations on a non-discriminatory basis;
Whereas in order to achieve full mutual recognition of licences, the Council will adopt, taking account of progress reached in the proceedings of international organizations, before 1 January 1993, on a proposal by the Commission to be submitted before 1 July 1992, the measures for harmonized requirements in respect of licences and training programmes; whereas each Member State will recognize any licence which satisfies these requirements,
Article 1
This Directive shall apply to procedures for mutual acceptance of licences issued by Member States to civil aviation cockpit personnel.
Article 2
For the purposes of this Directive (a) licence means any valid document, issued by a Member State, authorizing the holder to exercise functions as a member of the cockpit personnel on board a civil aircraft registered in a Member State. This definition also includes ratings associated with the document;
(b) rating means a statement entered on a licence, or in a separate document, setting forth special conditions, privileges or limitations pertaining to such licence;
(c) acceptance of licences means any act of recognition or validation by a Member State of a licence issued by another Member State together with the privileges and certificates pertaining thereto. The acceptance, which may be effected through the issue by the Member State of a licence of its own, shall not extend beyond the period of validity of the original licence;
(d) recognition means the permission to use on an aircraft registered in one Member State a licence issued in another Member State, in accordance with the privileges pertaining thereto;
(e) validation means the express declaration by a Member State that a licence issued by another Member State can be used as one of its own;
(f) cockpit personnel means personnel holding a licence and charged with duties essential to the operation of an aircraft during flight time. This definition applies to pilots, flight navigators and flight engineers.
Article 3
1. A Member State shall accept, without undue delay or additional tests, any licence issued by another Member State together with privileges and certificates pertaining thereto.
2. Any person holding a private pilot's licence issued by a Member State shall be permitted to fly aircraft registered in another Member State. This recognition shall be limited to the exercise of the privileges of the holder of a private pilot's licence and of associated aircraft ratings under visual flight rules (VFR) by day only in an aircraft certificated for single-pilot operations.
Article 4
1. Article 3 (1) shall apply where a licence issued by a Member State and presented to another Member State for acceptance is based on requirements which are equivalent to those of the host Member State. In order to enable the competent authorities to assess the equivalence of licences issued by other Member States, the Commission shall make, and forward to all the Member States before 1 January 1992, a comparison of the requirements applied in each Member State for issuing licences for the same functions.
2. (a) Any Member State may ask the Commission for an opinion on the equivalence of a licence, presented to it for acceptance, within three weeks of receiving the request.
(b) The Commission must deliver an opinion within two months. The Member State concerned shall then have a month to reply to the applicant.
(c) If a Member State does not ask the Commission for an opinion, it shall be bound to reply to the applicant within three months.
(d) The periods referred to in (a), (b) and (c) above shall start to run when all the necessary information is available.
3. If, after the examination of a licence by the Member State to which it has been presented for acceptance, reasonable doubts remain as to the equivalence of the licence concerned, that Member State may, notwithstanding the principles laid down in Article 3 (1), consider that additional requirements and/or tests are necessary to enable the licence to be accepted. The licence holder, the Member State which issued the licence and the Commission shall be informed thereof in writing. The opportunity to take an additional test shall be given to the licence holder by the host Member State to which the licence is submitted for approval as soon as possible, and in any event without discrimination on grounds of nationality.
4. Where the applicant has met the additional requirements and/or has passed the required test(s) as laid down in paragraph 3 the Member State concerned shall forthwith accept the licence in question.
5. Notwithstanding the above, with respect to pilot's licences and notwithstanding paragraphs 1 to 4, a Member State shall accept any licence issued in accordance with the requirements of Annex 1 to the Chicago Convention on International Civil Aviation if the bearer satisfies the special validation requirements laid down in the Annex to this Directive.
Article 5
Member States shall ensure that nationals of other Member States are admitted to public and private training establishments and to licensing examinations and procedures on the same basis as applies to their own nationals.
Article 6
When a Member State issues, for reasons of equivalence, a licence on the basis of a licence issued by a third country together with the privileges and certificates pertaining thereto, this shall be recorded in the licence. Other Member States shall not be obliged to accept any such licence.
Article 7
1. After consulting the Commission, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 June 1992. They shall forthwith inform the Commission thereof.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.
4. Member States shall assist one another in the implementation of this Directive and shall, if need be, exchange information on the licences they have accepted on grounds of equivalence.
5. The confidential information obtained pursuant to this Directive shall be covered by professional secrecy.
Article 8
This Directive is addressed to the Member States. | [
"UKPGA19760074",
"UKSI19951038",
"UKSI19922673"
] |
31991L0674 | 1991 | Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings
Having regard to the Treaty establishing the European Economic Community, and in particular Article 54 thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Article 54 (3) (g) of the Treaty requires coordination to the necessary extent of the safeguards which, for the protection of the interests of members and others, are required by Member States of companies and firms within the meaning of the second paragraph of Article 58 of the Treaty, with a view to making such safeguards equivalent throughout the Community;
Whereas Council Directive 78/660/EEC of 25 July 1978 based on Article 54 (3) (g) of the Treaty on the annual accounts of certain types of companies (4), as last amended by Directive 90/605/EEC (5), need not be applied to insurance companies, hereinafter referred to as 'insurance undertakings`, pending further coordination; whereas, in view of the major importance of insurance undertakings in the Community, such coordination cannot be delayed any longer following the implementation of Directive 78/660/EEC;
Whereas Council Directive 83/349/EEC of 13 June 1983 based on Article 54 (3) (g) of the Treaty on consolidated accounts (6), as last amended by Directive 90/605/EEC, provides for derogations for insurance undertakings only until the expiry of the deadline imposed for the application of this Directive; whereas this Directive must therefore also include provisions specific to insurance undertakings in respect of consolidated accounts;
Whereas such coordination is also urgently required because insurance undertakings operate across borders; whereas for creditors, debtors, members, policyholders and their advisers and for the general public, improved comparability of the annual accounts and consolidated accounts of such undertakings is of crucial importance;
Whereas in the Member States insurance undertakings of different legal forms are in competition with each other; whereas undertakings engaged in the business of direct insurance customarily engage in the business of reinsurance as well and are therefore in competition with specialist reinsurance undertakings; whereas it is therefore appropriate not to confine coordination to the legal forms covered by Directive 78/660/EEC, but to choose a scope that corresponds to that of Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct insurance other than life assurance (7), as last amended by Directive 90/618/EEC (8), and to that of Council Directive 79/267/EEC of 5 March 1979 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct life assurance (1), as last amended by Directive 90/619/EEC (2), but which also includes certain undertakings that are excluded from the scope of those Directives and companies and firms which are reinsurance undertakings;
Whereas, although in view of the specific characteristics of insurance undertakings it would appear appropriate to propose a separate Directive on the annual accounts and consolidated accounts of such undertakings, that does not necessarily require the establishment of a set of standards different from those of Directive 78/660/EEC and 83/349/EEC; whereas such separate standards would be neither appropriate nor consistent with the principles underlying the coordination of company law since, given the important position they occupy in the Community economy, insurance undertakings cannot be excluded from a framework of rules devised for undertakings generally; whereas, for this reason, only the particular characteristics of insurance undertakings have been taken into account and this Directive deals only with derogations from the rules laid down in Directives 78/660/EEC and 83/349/EEC;
Whereas there are major differences in the structure and content of the balance sheets of insurance undertakings in different Member States; whereas this Directive must therefore lay down the same structure and the same item designations for the balance sheets of all Community insurance undertakings;
Whereas, if annual accounts and consolidated accounts are to be comparable, a number of basic questions regarding the disclosure of certain transactions in the balance sheet must be settled;
Whereas, in the interests of greater comparability, it is also necessary that the content of the various balance sheet items be determined precisely;
Whereas it may be useful to distinguish between the commitments of the insurer and those of the reinsurer by showing in the assets the reinsurer's share of technical provisions as an asset;
Whereas the structure of the profit and loss account should also be determined and certain items in it should be defined;
Whereas, given the specific nature of the insurance industry, it may be useful for unrealized gains and losses to be dealt with in the profit and loss account;
Whereas the comparability of figures in the balance sheet and profit and loss account also depends basically on the values at which assets and liabilities are shown in the balance sheet; whereas for a proper understanding of the financial situation of an insurance undertaking the current value of investments as well as their value based upon the principle of purchase price or production cost must be disclosed; whereas, however, the compulsory disclosure of the current value of investments, at least in the notes on the accounts, is prescribed solely for purposes of comparability and transparency and is not intended to lead to changes in the tax treatment of insurance undertakings;
Whereas in the calculation of life assurance provisions use may be made of actuarial methods customarily applied on the market or accepted by the insurance-monitoring authorities; whereas those methods may be implemented by any actuary or expert in accordance with the conditions which may be laid down in national law and with due regard for the actuarial principles recognized in the framework of the present and future coordination of the fundamental rules for the prudential and financial monitoring of direct life assurance business;
Whereas, in the calculation of the provision for claims outstanding, on the one hand, any implicit discounting or deduction should be prohibited, and, on the other hand, precise conditions for recourse to explicit discounting or deduction should be defined, for the sake of prudence and transparency;
Whereas, in view of the special nature of insurance undertakings, certain changes are necessary with regard to the notes on annual accounts and on consolidated accounts;
Whereas, in line with the intention of covering all insurance undertakings that come within the scope of Directive 73/239/EEC and 79/267/EEC as well as certain others, derogations such as those for small and medium-sized insurance undertakings in Directive 78/660/EEC are not provided for, but certain small mutual associations which are excluded from the scope of Directives 73/239/EEC and 79/267/EEC should not be covered;
Whereas for the same reasons the scope allowed Member States pursuant to Directive 83/349/EEC to exempt parent undertakings of groups from compulsory consolidation if the undertakings to be consolidated do not together exceed a certain size has not been extended to insurance undertakings;
Whereas in view of its particular nature special provisions are needed for the association of underwriters known as Lloyd's;
Whereas the provisions of this Directive also apply to the consolidated accounts drawn up by a parent undertaking which is a financial holding company where its subsidiary undertakings are eiher exclusively or mainly insurance undertakings;
Whereas the examination of problems which arise in connection with this Directive, in particular regarding its application, requires cooperation by representatives of the Member States and the Commission in a contact committee; whereas, in order to avoid the proliferation of such committees, it is desirable that such cooperation take place in the committee provided for in Article 52 of Directive 78/660/EEC; whereas, however, when examining problems concerning insurance undertakings, the committee must be appropriately constituted;
Whereas, in view of the complexity of the matter, the insurance undertakings covered by this Directive must be allowed an appropriate period to implement its provisions; whereas that period must be extended to allow the necessary adjustments to be made concerning, on the one hand, the association of underwriters known as Lloyd's and, on the other, those undertakings which, when this Directive becomes applicable, show their investments at historical cost;
Whereas provision should be made for the review of certain provisions of this Directive after five years' experience of its application, in the light of the aims of greater transparency and harmonization.
SECTION 1 Preliminary provisions and scope
Article 1
1. Articles 2, 3, 4 (1), (3) to (5), 6, 7, 13, 14, 15 (3) and (4), 16 to 21, 29 to 35, 37 to 42, 43 (1), points 1 to 7 and 9 to 13, 45 (1), 46, 48 to 50, 51 (1), 54, 56 to 59 and 61 of Directive 78/660/EEC shall apply to the undertakings referred to in Article 2 of this Directive, except where this Directive provides otherwise.
2. Where reference is made in Directives 78/660/EEC and 83/349/EEC to Articles 9 and 10 (balance sheet) or to Articles 23 to 26 (profit and loss account) of Directive 78/660/EEC, such references shall be deemed to be references to Article 5 (balance sheet) or to Article 29 (profit and loss account) of this Directive as appropriate.
3. References in Directives 78/660/EEC and 83/349/EEC to Articles 31 to 42 of Directive 78/660/EEC shall be deemed to be references to those Articles, taking account of Articles 45 to 62 of this Directive.
4. Where the aforementioned provisions of Directive 78/660/EEC relate to balance-sheet items for which this Directive lays down no equivalent, they shall be deemed to be references to the items in Article 6 of this Directive where the corresponding assets and liabilities items are listed.
Article 2
1. The coordination measures prescribed by this Directive shall apply to companies and firms within the meaning of the second paragraph of Article 58 of the Treaty which are:
(a) undertakings within the meaning of Article 1 of Directive 73/239/EEC, excluding those mutual associations which are excluded from the scope of that Directive by virtue of Article 3 thereof but including those bodies referred to in Article 4 (a), (b), (c) and (e) thereof except where their activity does not consist wholly or mainly in carrying on insurance business;
(b)
undertakings within the meaning of Article 1 of Directive 79/267/EEC, excluding those bodies and mutual associations referred to in Articles 2 (2) and (3) and 3 of that Directive; or
(c)
undertakings carrying on reinsurance business.
In this Directive, such undertakings shall be referred to as insurance undertakings.
2. Funds of a group pension fund within the meaning of Article 1 (2) (c) and (d) of Directive 79/267/EEC which an insurance undertaking administers in its own name but on behalf of third parties must be shown in the balance sheet if the undertaking acquires legal title to the assets concerned. The total amount of such assets and liabilities shall be shown separately or in the notes on the accounts, broken down according to the various assets and liabilities items. However, the Member States may permit the disclosure of such funds as off-balance-sheet items provided there are special rules whereby such funds can be excluded from the assets available for distribution in the event of the winding up of an insurance undertaking (or similar proceedings).
Assets acquired in the name of and on behalf of third parties must not be shown in the balance sheet.
Article 3
Those provisions of this Directive which relate to life assurance shall apply mutatis mutandis to insurance undertakings which underwrite only health insurance and which do so exclusively or principally according to the technical principles of life assurance.
Member States may apply the first paragraph to health insurance underwritten by joint undertakings according to the technical principles of life assurance where such activity is significant.
Article 4
This Directive shall apply to the association of underwriters known as Lloyd's subject to the adaptations set out in the Annex to take account of the particular nature and structure of Lloyd's.
SECTION 2 General provisions concerning the balance sheet and the profit and loss account
Article 5
The combination of items under the conditions laid down in Article 4 (3) (a) or (b) of Directive 78/660/EEC shall be restricted in the case of insurance undertakings,
- as regards the balance sheet, to items preceded by arabic numerals, except for items concerning technical provisions, and
- as regards the profit and loss account, to items preceded by one or more lower-case letters, except for items I (1) and (4) and II (1), (5) and (6).
Combination shall be authorized only under the rules laid down by the Member States.
SECTION 3 Layout of the balance sheet
Article 6
The Member States shall prescribe the following layout for balance sheets:
Assets
A. Subscribed capital unpaid
showing separately called-up capital (unless national law requires called-up capital to be included under liabilities, in which case capital called but not yet paid must be included as an asset either under A or under E (IV)).
B.
Intangible assets
as described unter items B and C (I) of Article 9 of Directive 78/660/EEC, showing separately:
- formation expenses, as defined by national law and in so far as national law permits their being shown as an asset (unless national law requires their disclosure in the notes on the accounts),
- goodwill, to the extent that it was acquired for valuable consideration (unless national law requires its disclosure in the notes on the accounts).
C.
Investments
III. Land and buildings:
showing separately land and buildings occupied by an insurance undertaking for its own activities (unless national law requires their disclosure in the notes on the accounts).
III.
Investments in affiliated undertakings and participating interests:
1. Shares in affiliated undertakings.
2.
Debt securities issued by, and loans to, affiliated undertakings.
3.
Participating interests.
4.
Debt securities issued by, and loans to, undertakings with which an insurance undertaking is linked by virtue of a participating interest.
III.
Other financial investments:
1. Shares and other variable-yield securities and units in unit trusts.
2.
Debt securities and other fixed-income securities.
3.
Participation in investment pools.
4.
Loans guaranteed by mortgages.
5.
Other loans.
6.
Deposits with credit institutions.
7.
Other.
IV.
Deposits with ceding undertakings.
D.
Investments for the benefit of life-assurance policyholders who bear the investment risk
E.
Debtors
(Amounts owed by:
- affiliated undertakings, and
- undertakings with which an insurance undertaking is linked by virtue of participating interests
shall be shown separately, as sub-items of items I, II and III).
III. Debtors arising out of direct insurance operations
1. policyholders;
2. intermediaries.
III.
Debtors arising out of reinsurance operations.
III.
Other debtors.
IV.
Subscribed capital called but not paid
(unless national law requires that capital called but not paid be shown as an asset under A).
F.
Other assets
III. Tangible assets and stocks as listed under C (II) and D (I) in Article 9 of Directive 78/660/EEC, other than land and buildings, buildings under construction and deposits paid on land and buildings.
III.
Cash at bank and in hand.
III.
Own shares (with an indication of their nominal value or, in the absence of a nominal value, their accounting par value) to the extent that national law permits their being shown in the balance sheet.
IV.
Other.
G.
Prepayments and accrued income
III.
Accrued interest and rent.
III.
Deferred acquisition costs (distinguishing those arising in non-life insurance and life-assurance business).
III.
Other prepayments and accrued income.
H.
Loss for the financial year
(unless national law requires it to be shown as a liability under A (VI)).
Liabilities
A. Capital and reserves
III. Subscribed capital or equivalent funds
(unless national law requires called-up capital to be shown under this item. In that case, the amounts of subscribed capital and paid-up capital must be shown separately).
III.
Share premium account.
III.
Revaluation reserve.
IV.
Reserve.
IV.
Profit or loss brought forward.
VI.
Profit or loss for the financial year
(unless national law requires it to be shown as an asset under H or as a liability under I).
B.
Subordinated liabilities
C.
Technical provisions
1. Provision for unearned premiums:
(a) gross amount
.
(b)
reinsurance amount ( )
.
.
2.
Life assurance provision:
(a) gross amount ( )
.
(b)
reinsurance amount ( )
.
.
3.
Claims outstanding:
(a) gross amount
.
(b)
reinsurance amount ( )
.
.
4.
Provision for bonuses and rebates
(unless shown under 2):
(a) gross amount
.
(b)
reinsurance amount ( )
.
.
5.
Equalization provision
6.
Other technical provisions:
(a) gross amount
.
(b)
reinsurance amount ( )
.
.
D.
Technical provisions for life-assurance policies where the investment risk is borne by the policyholders:
(a) gross amount
.
(b)
reinsurance amount ( )
.
.
E. Provisions for other risks and charges
1. Provisions for pensions and similar obligations.
2.
Provisions for taxation.
3.
Other provisions.
F.
Deposits received from reinsurers
G.
Creditors
(Amounts owed to:
- affiliated undertakings, and
- undertakings with which an insurance undertaking is linked by virtue of a participating interest
shall be shown separately, as sub-items.)
III. Creditors arising out of direct insurance operations.
III.
Creditors arising out of reinsurance operations.
III.
Debenture loans, showing convertible loans separately.
IV.
Amounts owed to credit institutions.
IV.
Other creditors, including tax and social security.
H.
Accruals and deferred income
I.
Profit for the financial year
(unless national law requires it to be shown as a liability under A (VI)).
Article 7
Article 14 of Directive 78/660/EEC shall not apply to commitments linked to insurance activities.
SECTION 4 Special provisions relating to certain balance-sheet items
Article 8
Article 15 (3) of Directive 78/660/EEC shall apply only to assets items B and C (I) and (II) as defined in Article 6 of this Directive. Any movements in these items shall be shown on the basis of the balance-sheet value at the beginning of the financial year.
Article 9
Assets: item C (III) (2)
Debt securities and other fixed-income securities
1. This item shall comprise negotiable debt securities and other fixed-income securities issued by credit institutions, by other undertakings or by public bodies, in so far as they are not covered by item C (II) (2) or (4).
2. Securities bearing interest the rate of which varies in line with specific factors, for example the interest rate on the inter-bank market or on the Euromarket, shall also be regarded as debt securities and other fixed-income securities.
Article 10
Assets: item C (III) (3)
Participation in investment pools
This item shall comprise shares held by an undertaking in joint investments constituted by several undertakings or pension funds, the management of which has been entrusted to one of those undertakings or to one of those pension funds.
Article 11
Assets: items C (III) (4) and (5)
Loans guaranteed by mortgages and other loans
Loans to policyholders for which the policy is the main security shall be included under 'Other loans` and their amount shall be disclosed in the notes on the accounts. Loans guaranteed by mortgage shall be shown as such even where they are also secured by insurance policies. Where the amount of 'Other loans` not secured by policies is material, an appropriate breakdown shall be given in the notes on the accounts.
Article 12
Assets: item C (III) (6)
Deposits with credit institutions
This item shall comprise sums the withdrawal of which is subject to a time restriction. Sums deposited with no such restriction shall be shown under F (II) even if they bear interest.
Article 13
Assets: item C (III) (7)
Other
This item shall comprise those investments which are not covered by items C (III) (1) to (6). Where the amount of such investments is significant, they must be disclosed in the notes on the accounts.
Article 14
Assets: item C (IV)
Deposits with ceding undertakings
In the balance sheet of an undertaking which accepts reinsurance this item shall comprise amounts, owed by the ceding undertakings and corresponding to guarantees, which are deposited with those ceding undertakings or with third parties or which are retained by those undertakings.
These amounts may not be combined with other amounts owed by the ceding insurer to the reinsurer or set off against amounts owed by the reinsurer to the ceding insurer.
Securities deposited with ceding undertakings or third parties which remain the property of the undertaking accepting reinsurance shall be entered in the latter's accounts as an investment, under the appropriate item.
Article 15
Assets: item D
Investments for the benefit of life assurance policyholders who bear the investment risk.
In respect of life assurance this item shall comprise, on the one hand, investments the value of which is used to determine the value of or the return on policies relating to an investment fund and, on the other hand, investments serving as cover for liabilities which are determined by reference to an index. This item shall also comprise investments which are held on behalf of the members of a tontine and are intended for distribution among them.
Article 16
Assets: item F (IV)
Other
This item shall comprise those assets which are not covered by items F (I), (II) and (III). Where such assets are material, they must be disclosed in the notes on the accounts.
Article 17
Assets: item G (I)
Accrued interest and rent
This item shall comprise those items that represent interest and rent that have been earned up to the balance-sheet date but have not yet become receivable.
Article 18
Assets: item G (II)
Deferred acquisition costs
1. The costs of acquiring insurance policies shall be deferred in accordance with Article 18 of Directive 78/660/EEC in so far as such deferral is not prohibited by Member States.
2. Member States may, however, permit the deduction of acquisition costs from unearned premiums in non-life-insurance business and their deduction by an actuarial method from mathematical reserves in life-assurance business. Where this method is used, the amounts deducted from the provisions must be indicated in the notes on the accounts.
Article 19
Liabilities: item A (I)
Subscribed capital or equivalent funds
This item shall comprise all amounts, irrespective of their actual designations, which, in accordance with the legal structure of an insurance undertaking, are regarded under the national law of the Member State concerned as equity capital subscribed by the shareholders or other persons.
Article 20
Liabilities: item A (IV)
Reserves
This item shall comprise all the types of reserves listed in Article 9 of Directive 78/660/EEC under liabilities item A (IV), as defined therein. The Member States may also require other types of reserves if necessary for insurance undertakings the legal structures of which are not covered by Directive 78/660/EEC.
Reserves shall be shown separately, as sub-items of liabilities item A (IV), in the balance sheets of the insurance undertakings concerned, except for the revaluation reserve, which shall be shown as a liability under A (III).
Article 21
Liabilities: item B
Subordinated liabilities
Where it has been contractually agreed that, in the event of winding up or of bankruptcy, liabilities, whether or not represented by certificates, are to be repaid only after the claims of all other creditors have been met, the liabilities in question shall be shown under this item.
Article 22
Where a Member States permits an undertaking's balance sheet to include funds the allocation of which either to policyholders or to shareholders has not been determined by the close of the financial year, those amounts shall be shown as liabilities under an item Ba (Fund for future appropriations).
Variations in this item shall derive from an item II (12a) (Transfers to or from the fund for future appropriations) in the profit and loss account.
Article 23
Liabilities: item C
Technical provisions
Article 20 of Directive 78/660/EEC shall apply to technical provisions, subject to Articles 24 to 30 of this Directive.
Article 24
Liabilities: items C (1) (b), (2) (b), (3) (b), (4) (b) and (6) (b) and D (b)
Reinsurance amounts
1. The reinsurance amounts shall comprise the actual or estimated amounts which, under contractual reinsurance arrangements, are deducted from the gross amounts of technical provisions.
2. As regards the provision for unearned premiums, the reinsurance amounts shall be calculated according to the methods referred to in Article 57 or in accordance with the terms of the reinsurance policy.
3. Member States may require or permit the reinsurance amounts to be shown as assets. Where this option is exercised, those amounts shall be shown as assets under an item Da (Reinsurers' share of technical provisions), subdivided as follows:
1. Provision for unearned premiums
2.
Life assurance provision
3.
Claims outstanding
4.
Provisions for bonuses and rebates (unless shown under 2)
5.
Other technical provisions
6.
Technical provisions for life-assurance policies where the investment risk is borne by the policyholders.
Notwithstanding Article 5, these items shall not be combined.
Article 25
Liabilities: item C (1)
Provision for unearned premiums
The provision for unearned premiums shall comprise the amount representing that part of gross premiums written which is to be allocated to the following financial year or to subsequent financial years. In the case of life assurance Member States may, pending further harmonization, require or permit the provision for unearned premiums to be included in item C (2).
If, pursuant to Article 26, item C (1) also includes the amount of the provision for unexpired risks, the description of the item shall be 'Provision for unearned premiums and unexpired risks`. Where the amount for unexpired risks is material, it shall be disclosed separately either in the balance sheet or in the notes on the accounts.
Article 26
Liabilities: item C (6)
Other technical provisions
This item shall comprise, inter alia, the provision for unexpired risks, i.e. the amount set aside in addition to unearned premiums in respect of risks to be borne by the insurance undertaking after the end of the financial year, in order to provide for all claims and expenses in connection with insurance contracts in force in excess of the related unearned premiums and any premiums receivable on those contracts. However, if national legislation so provides, the provision for unexpired risks may be added to the provision for unearned premiums, as defined in Article 25, and included in the amount shown under item C (1).
Where the amount of unexpired risks is significant, it shall be disclosed separately either in the balance sheet or in the notes on the accounts.
Where the option provided for in the second paragraph of Article 3 is not exercised, this item shall also include the ageing reserves.
Article 27
Liabilities: item C (2)
Life assurance provision
The life assurance provision shall comprise the actuarially estimated value of an insurance undertaking's liabilities including bonuses already declared and after deducting the actuarial value of future premiums.
Article 28
Liabilities: item C (3)
Claims outstanding
The provision for claims outstanding shall be the total estimated ultimate cost to an insurance undertaking of settling all claims arising from events which have occured up to the end of the financial year, whether reported or not, less amounts already paid in respect of such claims.
Article 29
Liabilities: item C (4)
Provision for bonuses and rebates
The provision for bonuses and rebates shall comprise amounts intended for policyholders or contract beneficiaries by way of bonuses and rebates as defined in Article 39 to the extent that such amounts have not been credited to policyholders or contract beneficiaries or included in an item Ba (Fund for future appropriations), as provided for in Article 22, first paragraph, or in item C (2).
Article 30
Liabilities: item C (5)
Equalization provision
1. The equalization provision shall comprise any amounts set aside in compliance with legal or administrative requirements to equalize fluctuations in loss ratios in future years or to provide for special risks.
2. Where, in the absence of any such legislative or administrative requirements, reserves within the meaning of Article 20 have been constituted for the same purpose, this shall be disclosed in the notes on the accounts.
Article 31
Liabilities: item D
Technical provisions for life-assurance policies where the investment risk is borne by the policyholders.
This item shall comprise technical provisions constituted to cover liabilities relating to investment in the context of life assurance policies the value of or the return on which is determined by reference to investments for which the policyholder bears the risk, or by reference to an index.
Any additional technical provisions constituted to cover death risks, operating expenses or other risks (such as benefits payable at the maturity date or guaranteed surrender values) shall be shown under item C (2).
Item D shall also comprise technical provisions representing the obligations of a tontine's organizer vis-à-vis its members.
Article 32
Liabilities: item F
Deposits received from reinsurers
In the balance sheet of an undertaking ceding reinsurance this item shall comprise amounts deposited by or withheld from other insurance undertakings under reinsurance contracts. These amounts may not be merged with other amounts owed to or by the other undertakings in question.
Where an undertaking ceding reinsurance has received as a deposit securities which have been transferred to its ownership, this item shall comprise the amount owed by the ceding undertaking by virtue of the deposit.
SECTION 5 Layout of the profit and loss account
Article 33
1. The Member States shall prescribe the layout shown in Article 34 for profit and loss accounts.
2. The technical account for non-life-insurance business shall be used for those classes of direct insurance which are within the scope of Directive 73/239/EEC and for the corresponding classes of reinsurance business.
3. The technical account for life-assurance business shall be used for those classes of direct insurance which are within the scope of Directive 79/267/EEC and for the corresponding classes of reinsurance business.
4. Member States may require or permit undertakings the activities of which consist wholly of reinsurance to use the technical account for non-life-insurance business for all their business. This shall also apply to undertakings underwriting direct non-life-insurance and also reinsurance.
Article 34
Profit and loss account
III. Technical account - Non-life-insurance business
1. Earned premiums, net of reinsurance:
(a) gross premiums written
.
(b)
outward reinsurance premiums ( )
.
.
(c)
change in the gross provision for unearned premiums and, in so far as national legislation authorizes the inclusion of this provision in liabilities item C (1), in the provision for unexpired risks (+/ )
.
(d)
change in the provision for unearned premiums, reinsurers' share (+/ )
.
.
.
2.
Allocated investment return transferred from the non-technical account (item III (6))
.
3.
Other technical income, net of reinsurance
.
4.
Claims incurred, net of reinsurance:
(a)
claims paid
(aa) gross amount
.
(bb)
reinsurers' share ( )
.
.
(b)
change in the provision for claims,
(aa)
gross amount
.
(bb)
reinsurers' share ( )
.
.
.
5.
Changes in other technical provisions, net of reinsurance, not shown under other headings (+/ )
.
6.
Bonuses and rebates, net of reinsurance
.
7.
Net operating expenses:
(a)
acquisition costs
.
(b)
change in deferred acquisition costs (+/ )
.
(c)
administrative expenses
.
(d)
reinsurance commissions
and profit participation ( )
.
.
8.
Other technical charges, net of reinsurance
.
9.
Change in the equalization provision (+/ )
.
10.
Sub-total (balance on the technical account for non-life-insurance business (item III 1)).
.
III.
Technical account - Life-assurance business
1. Earned premiums, net of reinsurance:
(a) gross premiums written
.
(b)
outward reinsurance premiums ( )
.
(c)
change in the provision for unearned premiums, net of reinsurance (+/ )
.
.
2.
Investment income:
(a)
income from participating interests,
with a separate indication of that derived from affiliated undertakings .................
.
(b)
income from other investments,
with a separate indication of that derived from affiliated undertakings .................
(aa) income from land and buildings
.
(bb)
income from other investments
.
.
(c)
value re-adjustments on investments
.
(d)
gains on the realization of investments
.
.
3.
Unrealized gains on investments
.
4.
Other technical income, net of reinsurance
.
5.
Claims incurred, net of reinsurance:
(a)
claims paid
(aa)
gross amount
.
(bb)
reinsurers' share ( )
.
.
(b)
change in the provision for claims
(aa)
gross amount
.
(bb)
reinsurers' share ( )
.
.
.
6.
Change in other technical provisions, net of reinsurance, not shown under other headings (+/ ):
(a)
life assurance provision, net of reinsurance
(aa)
gross amount
.
(bb)
reinsurers' share ( )
.
.
(b)
other technical provisions, net of reinsurance
.
.
7.
Bonuses and rebates, net of reinsurance
.
8.
Net operating expenses:
(a)
acquisition costs,
.
(b)
change in deferred acquisition costs (+/ )
.
(c)
administrative expenses
.
(d)
reinsurance commissions
and profit participation ( )
.
.
9.
Investment charges:
(a)
investment management charges, including interest
.
(b)
value adjustments on investments
.
(c)
losses on the realization of investments
.
.
10.
Unrealized losses on investments
.
11.
Other technical charges, net of reinsurance
.
12.
Allocated investment return transferred to the non-technical account ( ) (item III 4))
.
13.
Sub-total: (balance on the technical account - life assurance business) (item III 2))
.
III.
Non-technical account 1. Balance on the technical account - non-life-insurance business (item I (10))
.
2.
Balance on the technical account - life-assurance business (item II (13))
.
3.
Investment income
(a) income from participating interests,
with a separate indication of that derived from affiliated undertakings .................
.
(b)
income from other investments,
with a separate indication of that derived from affiliated undertakings .................
(aa) income from land and buildings
.
(bb)
income from other investments
.
.
(c)
value re-adjustments on investments
.
(d)
gains on the realization of investments
.
.
4.
Allocated investment return transferred from the life-assurance technical account (item II (12))
.
5.
Investment charges:
(a)
investment management charges, including interest
.
(b)
value adjustments on investments
.
(c)
losses on the realization of investments
.
.
6.
Allocated investment return transferred to the non-lifeinsurance technical account (item I 2))
.
7.
Other income
.
8.
Other charges, including value adjustments
.
9.
Tax on profit or loss on ordinary activities
.
10.
Profit or loss on ordinary activities after tax
.
11.
Extraordinary income
.
12.
Extraordinary charges
.
13.
Extraordinary profit or loss
.
14.
Tax on extraordinary profit or loss
.
15.
Other taxes not shown under the preceding items
.
16.
Profit or loss for the financial year
.
SECTION 6 Special provisions relating to certain profit-and-loss-account items
Article 35
Non-life-insurance technical account: item I (1) (a)
Life-assurance technical account: item II (1) (a)
Gross premiums written
Gross premiums written shall comprise all amounts due during the financial year in respect of insurance contracts regardless of the fact that such amounts may relate in whole or in part to a later financial year, and shall include inter alia:
ii(i) premiums yet to be written, where the premium calculation can be done only at the end of the year:
i(ii)
- single premiums, including annuity premiums,
- in life assurance, single premiums resulting from bonus and rebate provisions in so far as they must be considered as premiums on the basis of contracts and where national legislation requires or permits their being shown under premiums;
(iii)
additional premiums in the case of half-yearly, quarterly or monthly payments and additional payments from policyholders for expenses borne by the insurance undertaking;
(iv)
in the case of co-insurance, the undertaking's portion of total premiums;
i(v)
reinsurance premiums due from ceding and retroceding insurance undertakings, including portfolio entries,
after deduction of:
- portfolio withdrawals credited to ceding and retroceding insurance undertakings, and
- cancellations.
The above amounts shall not include the amounts of taxes or charges levied with premiums.
Article 36
Non-life-insurance technical account: item I (1) (b)
Life-assurance technical account: item II (1) (b)
Outward reinsurance premiums
Outward reinsurance premiums shall comprise all premiums paid or payable in respect of outward reinsurance contracts entered into by an insurance undertaking. Portfolio entries payable on the conclusion or amendment of outward reinsurance contracts shall be added; portfolio withdrawals receivable must be deducted.
Article 37
Non-life-insurance technical account: items I (1) (c) and (d)
Life-assurance technical account: item II (1) (c)
Change in the provision for unearned premiums, net of reinsurance
Pending further coordination, Member States may, in the case of life assurance, require or permit the change in unearned premiums to be included in the change in the life assurance provision.
Article 38
Non-life-insurance technical account: item I (4)
Life-assurance technical account: item II (5)
Claims incurred, net of reinsurance
1. Claims incurred shall comprise all payments made in respect of the financial year plus the provision for claims but minus the provision for claims for the preceding financial year.
These amounts shall include annuities, surrenders, entries and withdrawals of loss provisions to and from ceding insurance undertakings and reinsurers, external and internal claims management costs and charges for claims incurred but not reported such as referred to in Article 60 (1) (b) and (2) (a).
Sums recoverable on the basis of subrogation and salvage within the meaning of Article 60 (1) (d) shall be deducted.
2. Where the difference between:
- the loss provision made at the beginning of the year for outstanding claims incurred in previous years, and
- the payments made during the year on account of claims incurred in previous years and the loss provision shown at the end of the year for such outstanding claims is material,
it shall be disclosed in the notes on the accounts, broken down by category and amount.
Article 39
Non-life-insurance technical account: item I (6)
Life-assurance technical account: item II (7)
Bonuses and rebates, net of reinsurance
Bonuses shall comprise all amounts chargeable for the financial year which are paid or payable to policyholders and other insured parties or provided for their benefit, including amounts used to increase technical provisions or applied to the reduction of future premiums, to the extent that such amounts represent an allocation of surplus or profit arising on business as a whole or a section of business, after deduction of amounts provided in previous years which are no longer required.
Rebates shall comprise such amounts to the extent that they represent a partial refund of premiums resulting from the experience of individual contracts.
Where material, the amount charged for bonuses and that charged for rebates shall be disclosed separately in the notes on the accounts.
Article 40
Non-life-insurance technical account: item I (7) (a)
Life-assurance technical account: item II (8) (a)
Acquisition costs
Acquisition costs shall comprise the costs arising from the conclusion of insurance contracts. They shall cover both direct costs, such as acquisition commissions or the cost of drawing up the insurance document or including the insurance contract in the portfolio, and indirect costs, such as advertising costs or the administrative expenses connected with the processing of proposals and the issuing of policies.
Member States may require policy renewal commissions to be entered in item I (7) (c) or II (8) (c).
Article 41
Non-life-insurance technical account: item I (7) (c)
Life-assurance technical account: item II (8) (c)
Administrative expenses
Administrative expenses shall include the costs arising from premium collection, portfolio administration, handling of bonuses and rebates, and inward and outward reinsurance. They shall in particular include staff costs and depreciation provisions in respect of office furniture and equipment in so far as these need not be shown under acquisition costs, claims incurred or investment charges.
Article 42
Life-insurance technical account: items II (2) and (9)
Non-technical account: items III (3) and (5)
Investment income and charges
1. All investment income and charges relating to non-life insurance shall be disclosed in the non-technical account.
2. In the case of an undertaking carrying on life-assurance business only, investment income and charges shall be disclosed in the life-assurance technical account.
3. In the case of an undertaking carrying on both life-assurance and non-life-insurance business, investment income and charges shall, to the extent that they are directly connected with the carrying on of the life-assurance business, be disclosed in the life-assurance technical account.
4. Member States may require or permit the disclosure of investment income and charges according to the origin or attribution of the investments, if necessary by providing for further items in the non-life-insurance technical account, by analogy with the corresponding items in the life-assurance technical account.
Article 43
Non-life-insurance technical account: item I (2)
Life-assurance technical account: item II (2)
Non-technical account: items III (4) and (6)
Allocated investment return
1. Where part of the investment return is transferred to the non-life-insurance technical account, the transfer from the non-technical account shall be deducted from item III (6) and added to item I (2).
2. Where part of the investment return disclosed in the life-assurance technical account is transferred to the non-technical account, the amount transferred shall be deducted from item II (12) and added to item III (4).
3. Member States may lay down the procedures for and the amounts of transfers of allocated return from one part of the profit and loss account to another. The reasons for such transfers and the bases on which they are made shall be disclosed in the notes on the accounts in either event; where appropriate, a reference to the text of the relevant regulation shall suffice.
Article 44
Life-assurance technical account: items II (3) and (10)
Unrealized gains and losses on investments
1. In life-assurance business Member States may permit the disclosure in full or in part in items II (3) and (10) in the profit and loss account of variations in the difference between:
- the valuation of investments at their current value or by means of one of the methods referred to in Article 33 (1) of Directive 78/660/EEC, and
- their valuation at purchase price.
In any event, Member States shall require that the amounts referred to in the first paragraph be disclosed in the aforementioned items where they relate to investments shown as assets under D.
2. Member States which require or permit the valuation of the investments shown as assets under C at their current value may, in respect of non-life-insurance, permit the disclosure in full or in part in an item III (3a) and in an item III (5a) in the profit and loss account of the variation in the difference between the valuation of those investments at their current value and their valuation at purchase price.
SECTION 7 Valuation rules
Article 45
Article 32 of Directive 78/660/EEC, under which the valuation of items shown in the annual accounts must be based on the principle of purchase price or production cost, shall apply to investment subject to Articles 46 to 49 of this Directive.
Article 46
1. Member States may require or permit the valuation of investments shown as assets under C on the basis of their current value calculated in accordance with Articles 48 and 49.
2. The investments shown as assets under D shall be shown at their current value.
3. Where investments are shown at their purchase price, their current value shall be disclosed in the notes on the accounts.
However, Member States in which, on the date of the notification of this Directive, investments are shown at their purchase price may give undertakings the option of initially disclosing in the notes on the account the current value of investment shown as assets under C (I) no later than five years after the date referred to in Article 70 (1) and the current value of other investments no later than three years after the same date.
4. Where investments are shown at their current value, their purchase price shall be disclosed in the notes on the accounts.
5. The same valuation method shall be applied to all investments included in any item denoted by an arabic numeral or shown as assets under C (I).
6. The method applied to each investment item shall be stated in the notes on the accounts.
Article 47
Where current value is applied to investments, Article 33 (2) and (3) of Directive 78/660/EEC shall apply, except as provided in Articles 37 and 44 of this Directive.
Article 48
1. In the case of investments other than land and buildings, current value shall mean market value, save as provided in paragraph 5.
2. Where investments are officially listed on an official stock exchange, market value shall mean the value on the balance-sheet date or, when the balance-sheet date is not a stock-exchange trading day, on the last stock-exchange trading day before that date.
3. Where a market exists for investments other than those referred to in paragraph 2, market value shall mean the average price at which such investments were traded on the balance-sheet date or, when the balance-sheet date is not a trading day, on the last trading day before that date.
4. Where on the date on which the accounts are drawn up investments such as referred to in paragraphs 2 or 3 have been sold or are to be sold within the short term, the market value shall be reduced by the actual or estimated realization costs.
5. Except where the equity method is applied in accordance with Article 59 of Directive 78/660/EEC, all other investments shall be valued on a basis which has prudent regard to the likely realizable value.
6. In all cases the method of valuation shall be precisely described and the reason for adopting it stated in the notes on the accounts.
Article 49
1. In the case of land and buildings current value shall mean the market value on the date of valuation, where relevant reduced as provided in paragraphs 4 and 5.
2. Market value shall mean the price at which land and buildings could be sold under private contract between a willing seller and an arm's length buyer on the date of valuation, it being assumed that the property is publicly exposed to the market, that market conditions permit orderly disposal and that a normal period, having regard to the nature of the property, is available for the negotiation of the sale.
3. The market value shall be determined through the separate valuation of each land and buildings item, carried out at least every five years according to methods generally recognized or recognized by the insurance supervisory authorities. Article 35 (1) (b) of Directive 78/660/EEC shall not apply.
4. Where the value of any land and buildings item has diminished since the preceding valuation under paragraph 3, an appropriate value adjustment shall be made. The lower value thus arrived at shall not be increased in subsequent balance sheets unless such increase results from a new determination of market value arrived at in accordance with paragraphs 2 and 3.
5. Where on the date on which the accounts are drawn up land and buildings have been sold or are to be sold within the short term, the value arrived at in accordance with paragraphs 2 and 4 shall be reduced by the actual or estimated realization costs.
6. Where it is impossible to determine the market value of a land and buildings item, the value arrived at on the basis of the principle of purchase price or production cost shall be deemed to be the current value.
7. The method by which the current value of land and buildings has been arrived at and their breakdown by financial year of valuation shall be disclosed in the notes on the accounts.
Article 50
Where Article 33 of Directive 78/660/EEC is applied to insurance undertakings, it shall be so in the following manner:
(a) paragraph 1 (a) shall apply to assets shown under F (I) as defined in Article 6 of this Directive;
(b)
paragraph 1 (c) shall apply to assets shown under C (I), (II), (III) and (IV) and F (I) (except for stocks) and (III) as defined in Article 6 of this Directive.
Article 51
Article 35 of Directive 78/660/EEC shall apply to insurance undertakings subject to the following provisions:
(a)
it shall apply to assets shown under B and C and to fixed assets shown under F (I) as defined in Article 6 of this Directive;
(b)
paragraph 1 (c) (aa) shall apply to assets shown under C (II), (III) and (IV) and F (III) as defined in Article 6 of this Directive.
Member States may require that value adjustments be made in respect of transferable securities shown as investments, so that they are shown at the lower value to be attributed to them at the balance-sheet date.
Article 52
Article 38 of Directive 78/660/EEC shall apply to assets shown under F (I) as defined in Article 6 of this Directive.
Article 53
Article 39 of Directive 78/660/EEC shall apply to assets shown under E (I), (II) and (III) and F (II) as defined in Article 6 of this Directive.
Article 54
In non-life insurance the amount of any deferred acquisition costs shall be established on a basis compatible with that used for unearned premiums.
In life assurance the calculation of the amount of any acquisition costs to be deferred may be taken into the actuarial calculation referred to in Article 59.
Article 55
1. (a) If they have not been valued at market value, debt securities and other fixed-income securities shown as assets under C (II) and (III) shall be shown in the balance sheet at purchase price. Member States may, however, require or permit such debt securities to be shown in the balance sheet at the amount repayable at maturity.
(b)
Where the purchase price of the securities referred to in point (a) exceeds the amount repayable at maturity, the amount of the difference shall be charged to the profit and loss account. Member States may, however, require or permit the amount of the difference to be written off in instalments so that it is completely written off when the securities are repaid. That difference must be shown separately in the balance sheet or in the notes on the accounts.
(c)
Where the purchase price of the securities referred to in point (a) is less than the amount repayable at maturity, Member States may require or permit the amount of the difference to be released to income in instalments over the period remaining until repayment. That difference must be shown separately in the balance sheet or in the notes on the accounts.
2. Where debt securities or other fixed-income securities that are not valued at market value are sold before maturity and the proceeds are used to purchase other debt securities or fixed-income securities, Member States may permit the difference between the proceeds of sale and their book value to be spread uniformly over the period remaining until the maturity of the original investment.
Article 56
Technical provisions
The amount of technical provisions must at all times be such that an undertaking can meet any liabilities arising out of insurance contracts as far as can reasonably be foreseen.
Article 57
Provision for unearned premiums
1. The provision for unearned premiums shall in principle be computed separately for each insurance contract. Member States may, however, permit the use of statistical methods, and in particular proportional and flat-rate methods, where they may be expected to give approximately the same results as individual calculations.
2. In classes of insurance where the assumption of a temporal correlation between risk experience and premium is not appropriate, calculation methods shall be applied that take account of the differing pattern of risk over time.
Article 58
Provision for unexpired risks
The provision for unexpired risks referred to in Article 26 shall be computed on the basis of claims and administrative expenses likely to arise after the end of the financial year from contracts concluded before that date, in so far as their estimated value exceeds the provision for unearned premiums and any premiums receivable under those contracts.
Article 59
Life assurance provision
1. The life assurance provision shall in principle be computed separately for each life assurance contract. Member States may, however, permit the use of statistical or mathematical methods where they may be expected to give approximately the same results as individual calculations. A summary of the principal assumptions made shall be given in the notes on the accounts.
2. The computation shall be made annually by an actuary or other specialist in this field on the basis of recognized actuarial methods.
Article 60
Provisions for claims outstanding
1. Non-life insurance
(a) A provision shall in principle be computed separately for each case on the basis of the costs still expected to arise. Statistical methods may be used if they result in an adequate provision having regard to the nature of the risks; Member States may, however, make the application of such methods subject to prior approval.
(b)
This provision shall also allow for claims incurred but not reported by the balance-sheet date; its amount shall be determined having regard to past experience as to the number and magnitude of claims reported after the balance-sheet date.
(c)
Claims settlement costs shall be included in the calculation of the provision irrespective of their origin.
(d) Recoverable amounts arising out of the acquisition of the rights of policyholders with respect to third parties (subrogation) or of the legal ownership of insured property (salvage) shall be deducted from the provision for claims outstanding; they shall be estimated on a prudent basis. Where such amounts are material, they shall be disclosed in the notes on the accounts.
(e)
By way of derogation from subparagraph (d), Member States may require or permit the disclosure of recoverable amounts as assets.
(f)
Where benefits resulting from a claim must be paid in the form of annuity, the amounts to be set aside for that purpose shall be calculated by recognized actuarial methods.
(g)
Implicit discounting or deductions, whether resulting from the placing of a present value on a provision for an outstanding claim which is expected to be settled later at a higher figure or otherwise effected, shall be prohibited.
Member States may permit explicit discounting or deductions to take account of investment income. N° such discounting or deductions shall be permissible unless:
ii(i) the expected average date for the settlement of claims is at least four years after the accounting date;
i(ii)
the discounting or deduction is effected on a recognized prudential basis; the competent authority must be given advance notification of any change in method;
(iii)
when calculating the total cost of settling claims, an undertaking takes account of all factors that could cause increases in that cost;
(iv)
an undertaking has adequate data at its disposal to construct a reliable model of the rate of claims settlements;
i(v)
the rate of interest used for the calculation of present values does not exceed a prudent estimate of the investment income from assets invested as a provision for claims during the period necessary for the payment of such claims. Moreover, it must not exceed either of the following:
- the investment income from such assets over the preceding five years,
- the investment income from such assets during the year preceding the balance-sheet date.
When discounting or effecting deductions, an undertaking shall, in the notes on its accounts, disclose the total amount of provisions before discounting or deduction, the categories of claims which are discounted or from which deductions have been made and, for each category of claims, the methods used, in particular the rates used for the estimates referred to in the preceding subparagraph, points (iii) and (v), and the criteria adopted for estimating the period that will elapse before the claims are settled.
2. Life insurance
(a) The amount of the provision for claims shall be equal to the sums due to beneficiaries, plus the costs of settling claims. It shall include the provision for claims incurred but not reported.
(b)
Member States may require the disclosure in liabilities item C (2) of the amounts referred to in (a).
Article 61
1. Pending further coordination, Member States may require or permit the application of the following methods where, because of the nature of the class or type of insurance in question, information about premiums receivable, claims payable or both for the underwriting years is insufficient when the annual accounts are drawn up for accurate estimates to be made.
Method 1
The excess of the premiums written over the claims and expenses paid in respect of contracts commencing in the underwriting year shall form a technical provision which is included in the technical provision for claims outstanding shown in the balance sheet in liabilities item C (3). The provision may also be computed on the basis of a given percentage of the premiums written where such a method is appropriate for the type of risk insured. Should the need arise, the amount of this technical provision shall be increased to make it sufficient to meet present and future obligations. The technical provision constituted by this method shall be replaced by a provision for claims outstanding estimated in the usual manner as soon as sufficient information has been gathered and not later than the end of the third year following the underwriting year.
Method 2
The figures shown in the technical account or in certain items within it shall relate to a year which wholly or partly precedes the financial year. It must not do so by more than 12 months. The amounts of the technical provisions shown in the annual accounts shall if necessary be increased to make them sufficient to meet present and future obligations.
2. Where one of the methods described in paragraph 1 is adopted, it shall be applied systematically in successive years unless circumstances justify a change. The use of either method shall be disclosed in the notes on the accounts and the reasons given; in the event of a change in the method applied, the effect on the assets, liabilities, financial position and profit or loss shall be indicated in the notes on the accounts. Where Method 1 is used, the length of time that elapses before a provision for claims outstanding is constituted on the usual basis shall be disclosed in the notes on the accounts. Where Method 2 is used, the length of time by which the earlier year to which the figures relate precedes the financial year and the magnitude of the transactions concerned shall be disclosed in the notes on the accounts.
3. For the purposes of this Article, 'underwriting year` shall mean the financial year in which the insurance contracts in the class or type of insurance in question commenced.
Article 62
Pending further coordination, those Member States which require the constitution of equalization provisions shall prescribe the valuation rules to be applied to them.
SECTION 8 Contents of the notes on the accounts
Article 63
In place of the information provided for in Article 43 (1) (8) of Directive 78/660/EEC, insurance undertakings shall provide the following particulars:
III. As regards non-life insurance, the notes on the accounts shall disclose:
1. gross premiums written;
2.
gross premiums earned;
3.
gross claims charges;
4.
gross operating expenses;
5.
the reinsurance balance.
These amounts shall be shown broken down between direct insurance and reinsurance acceptances, if reinsurance acceptances amount to 10 % or more of gross premiums written, and then within direct insurance into the following groups of classes:
- accident and health,
- motor, third-party liability,
- motor, other classes,
- marine, aviation and transport,
- fire and other damage to property,
- third-party liability,
- credit and suretyship,
- legal expenses,
- assistance,
- miscellaneous.
The breakdown into groups of classes within direct insurance shall not be required where the amount of the gross premiums written in direct insurance for the group in question does not exceed ECU 10 million. However, undertakings shall in any case disclose the amounts relating to the three largest groups of classes in their business.
III.
As regards life assurance, the notes on the accounts shall disclose:
1. gross premiums written, broken down between direct insurance and reinsurance acceptances, if reinsurance acceptances amount to 10 % or more of gross premiums written, and then within direct insurance to indicate:
(a) ii(i) individual premiums;
i(ii)
premiums under group contracts;
(b)
ii(i)
periodic premiums;
i(ii)
single premiums;
(c)
ii(i) premiums from non-bonus contracts;
i(ii)
premiums from bonus contracts;
(iii)
premiums from contracts where the investment risk is borne by policyholders.
Disclosure of the figure relating to (a), (b) or (c) shall not be required where it does not exceed 10 % of the gross premiums written in direct insurance;
2.
the reinsurance balance;
III.
In the case covered by Article 33 (4), gross premiums broken down between life assurance and non-life insurance.
IV.
In all cases, the total gross direct insurance premiums resulting from contracts concluded by the insurance undertaking
- in the Member State of its head office,
- in the other Member States, and
- in other countries,
except that disclosure of the figure relating to the above shall not be required if they do not exceed 5 % of total gross premiums.
Article 64
In the notes on their accounts insurance undertakings shall disclose the total amount of commissions for direct insurance business taken into the accounts for the financial year. This requirement shall cover commissions of any kind, and in particular acquisition, renewal, collection and portfolio management commissions.
SECTION 9 Provisions relating to consolidated accounts
Article 65
1. Insurance undertakings shall draw up consolidated accounts and consolidated annual reports in accordance with Directive 83/349/EEC, save as otherwise provided in this section.
2. In so far as a Member State does not have recourse to Article 5 of Directive 83/349/EEC, paragraph 1 shall also apply to parent undertakings, the sole or essential object of which is to acquire holdings in subsidiary undertakings and turn them to profit, where those subsidiary undertakings are either exclusively or mainly insurance undertakings.
Article 66
Directive 83/349/EEC shall apply subject to the following provisions:
1. Articles 4, 6, and 40 shall not apply;
2. the information referred to in the first and second indents of Article 9 (2), namely:
- the amount of the fixed assets, and
- the net turnover,
shall be replaced by particulars of the gross premiums written as defined in Article 35 of this Directive;
3.
a Member State may also apply Article 12 of Directive 83/349/EEC to two or more insurance undertakings which are not connected as described in Article 1 (1) or (2) of the same Directive but are managed on a unified basis other than pursuant to a contract or provisions of their memoranda or articles of association. Unified management may also consist of important and durable reinsurance links;
4.
Member States may permit derogations from Article 26 (1) (c) of Directive 83/349/EEC where a transaction has been concluded according to normal market conditions and has established policyholder rights. Any such derogation shall be disclosed and where they have a material effect on the assets, liabilities, financial position and profit or loss of all the undertakings included in the consolidation that fact shall be disclosed in the notes on the consolidated accounts;
5.
Article 27 (3) of Directive 83/349/EEC shall apply provided that the balance-sheet date of an undertaking included in a consolidation does not precede the consolidated balance-sheet date by more than six months;
6.
Article 29 of Directive 83/349/EEC shall not apply to those liabilities items, the valuation of which by the undertakings included in a consolidation is based on the application of provisions specific to insurance undertakings or to those assets items changes in the values of which also affect or establish policyholders' rights. Where recourse is had to this derogation, the fact shall be disclosed in the notes on the consolidated accounts.
Article 67
In consolidated accounts alone Member States may require or permit all investment income and charges to be disclosed in the non-technical account, even when such income and charges are connected with life-assurance business.
Furthermore, Member States may in such cases require or permit the allocation of part of the investment return to the life-assurance technical account.
SECTION 10 Publication
Article 68
1. The duly approved annual accounts of insurance undertakings, together with the annual reports and the reports by the persons responsible for auditing the accounts, shall be published as laid down by the laws of each Member State in accordance with Article 3 of Directive 68/151/EEC (;).
(;) OJ N° L 65, 14. 3. 1968, p. 8.
The laws of a Member State may, however, provide that annual reports need not be published as provided in the first subparagraph. In that event, they shall be made available to the public at the undertakings' head offices in the Member State concerned. It must be possible to obtain a copy of all or part of any such report upon request. The price of such a copy shall not exceed its administrative cost.
2. Paragraph 1 shall also apply to the duly approved consolidated accounts, the consolidated annual report and the reports by the persons responsible for auditing the accounts.
3. Where an insurance undertaking which has drawn up annual accounts or consolidated accounts is not established as one of the types of company listed in Article 1 (1) of Directive 78/660/EEC and is not required by its national law to publish the documents referred to in paragraph 1 and 2 of this Article as prescribed in Article 3 of Directive 68/151/EEC, it shall at least make them available to the public at its head office. It must be possible to obtain copies of such documents on request. The price of such copies shall not exceed their administrative cost.
4. Member States shall provide for appropriate sanctions for failure to comply with the publication rules laid down in this Article.
SECTION 11 Final provisions
Article 69
The contact committee set up pursuant to Article 52 of Directive 78/660/EEC shall also, when constituted appropriately, have the following functions:
(a) to facilitate, without prejudice to Articles 169 and 170 of the Treaty, harmonized application of this Directive through regular meetings dealing in particular with practical problems arising in connection with its application;
(b)
to advise the Commission, if the need arises, on additions or amendments to this Directive.
Article 70
1. Member States shall adopt the laws, regulations and administrative provisions necessary for them to comply with this Directive before 1 January 1994. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall include a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States may provide that the provisions referred to in paragraph 1 shall first apply to annual accounts and consolidated accounts for financial years beginning on 1 January 1995 or during the calendar year 1995.
3. Member States shall communicate to the Commission the texts of the main provisoins of national law which they adopt in the field governed by this Directive.
Article 71
Five years after the date referred to in Article 70 (2) the Council, acting on a proposal from the Commission, shall examine and if need be revise all those provisions of this Directive which provide for Member State options in the light of the experience acquired in applying this Directive and in particular of the aims of greater transparency and harmonization of the provisions referred to by this Directive.
Article 72
This Directive is addressed to the Member States. | [
"UKSI19933245",
"UKSI19933246"
] |
31991L0682 | 1991 | Council Directive 91/682/EEC of 19 December 1991 on the marketing of ornamental plant propagating material and ornamental plants
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the production of ornamental plants occupies an important place in the agriculture of the Community;
Whereas satisfactory results in the cultivation of ornamental plants depend to a large extent on the quality and health of the material used for their propagation and of the plants themselves; whereas certain Member States have in consequence introduced rules intended to guarantee the quality and health of the propagating material of ornamental plants and ornamental plants placed on the market;
Whereas the different treatment accorded to propagating material and ornamental plants in different Member States is likely to create barriers to trade and thus hinder the free movement of these goods within the Community; whereas, with a view to achieving the internal market, these barriers should be removed, by adopting Community provisions to replace those laid down by the Member States;
Whereas the establishment of harmonized conditions at Community level will ensure that purchasers throughout the Community receive propagating material and ornamental plants which are healthy and of good quality;
Whereas, so far as they relate to plant health, such harmonized conditions must be consistent with Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction in to the Member States of organisms harmful to plants or plant products (4), as last amended by Directive 91/683/EEC (5);
Whereas it is appropriate initially to establish Community rules for those genera and species of ornamental plant which are of major economic importance in the Community, with a Community procedure for adding further genera and species later;
Whereas, without prejudice to the plant health provisions of Directive 77/93/EEC, it is not appropriate to apply the Community rules on the marketing of propagating material and ornamental plants when it is shown that such material and plants are intended for export to third countries, as the rules applicable there may be different from those contained in this Directive;
Whereas the determination of plant health and quality standards for each genus and species of ornamental plant requires lengthy and detailed technical and scientific consideration; whereas a procedure should accordingly be established for the determination of these standards;
Whereas in the first instance it is the responsibility of the suppliers of propagating material and/or ornamental plants to ensure that their products fufil the conditions laid down in this Directive;
Whereas the competent authorities of the Member States must, when carrying out controls and inspections, ensure that suppliers fulfil those conditions;
Whereas Community control measures should be introduced to ensure uniform application in all the Member States of the standards laid down in this Directive;
Whereas it is in the interests of the purchasers of propagating materials and ornamental plants that the names of varieties or of groups of plants be known and that their identity be safeguarded;
Whereas the characteristics specific to the industry operating in the ornamental plant sector are a complicating factor; whereas, accordingly, the objective stated above can best be achieved either through common knowledge of the variety or, in the case of varieties or groups of plants, through the availability of a description drawn up and kept by the supplier;
Whereas, in order to ensure the identity and orderly marketing of propagating material and ornamental plants, Community rules must be laid down concerning the separation of lots and marking; whereas the labels should give the particulars needed both for official control and for the information of the grower;
Whereas rules should be established permitting, in the case of temporary supply difficulties, the marketing of propagating material and ornamental plants subject to requirements less stringent than those contained in this Directive;
Whereas, as a first step towards harmonized conditions, Member States should be prohibited in the case of the genera and species referred to in the Annex, for which fact sheets will be drawn up, from imposing new conditions or marketing restrictions on propagating material or ornamental plants, other than those provided for in this Directive;
Whereas provision should be made for authorizing the marketing, within the Community, of propagating material and ornamental plants produced in third countries, provided always that they afford the same assurance as propagating material and ornamental plants produced in the Community and complying with Community rules;
Whereas, in order to harmonize technical methods of examination used in the Member States and to compare propagating material and ornamental plants produced in the Community with those produced in third countries, comparative trials should be carried out to check compliance of propagating material and ornamental plants with the requirements of this Directive;
Whereas, in order to facilitate the effective operation of this Directive, the Commission should be entrusted with the task of adopting measures for its implementation and for the amendment of its Annex; whereas such measures should be adopted by a procedure involving close cooperation between the Commission and the Member States within a Standing Committee on Propagating Material and Ornamental Plants,
Article 1
1. This Directive applies to the marketing of ornamental-plant-propagating material and ornamental plants within the Community.
2. Articles 2 to 20 and 24 shall apply to the genera and species listed in the Annex.
Rootstocks of other genera or species shall also be subject to the abovementioned Articles if material of one of the said genera or species is grafted on to them.
3. Amendments to the list of genera and species in the Annex shall be adopted in accordance with the procedure laid down in Article 22.
Article 2
This Directive shall not apply to propagating material or ornamental plants shown to be intended for export to third countries, if properly identified as such and kept sufficiently isolated, without prejudice to the health rules laid down by Directive 77/93/EEC.
Implementing measures for the first subparagraph, with particular reference to identification and isolation, shall be adopted in accordance with the procedure laid down in Article 21.
Article 3
For the purposes of this Directive, the following definitions shall apply:
(a) Propagating material: seeds, parts of plants and all plant material intended for the propagation and production of ornamental plants and other plants for ornamental purposes;
(b)
Ornamental plants: plants intended, after marketing, to be planted or replanted;
(c)
Supplier: any natural or legal person carrying out professionally at least one of the following activities with regard to propagating material or ornamental plants: reproducing, producing, preserving and/or treating and placing on the market;
(d)
Placing on the market: the holding available or in stock, displaying or offering for sale, selling and/or delivering to another person, in whatever form, of propagating material or ornamental plants;
(e)
Responsible official body:
1. the sole and central authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning quality;
2.
any State authority established:
- either at national level
- or at regional level, under the supervision of national authorities, within the limits set by the constitution of the Member State concerned.
The bodies referred to in 1 and 2 may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to any legal person, whether governed by public or by private law, which, under its officially approved constitution, is charged exclusively with specific public functions, provided that such person, and its members, has no personal interest in the outcome of the measures it takes.
The Member States shall ensure that there is close cooperation between the bodies referred to in 2 and those referred to in 1.
Moreover, in accordance with the procedure laid down in Article 21, other legal persons established on behalf of the body referred to in 1 and acting under the authority and supervision of such body may be approved, provided that such person has no personal interest in the outcome of the measures it takes.
Member States shall notify the Commission of their responsible official bodies. The Commission shall forward that information to the other Member States;
(f)
Official measures: measures taken by the responsible official body;
(g)
Official inspection: inspection carried out by the responsible official body;
(h)
Official statement: statement issued by, or under the responsibility of, the responsible official body;
(i)
Lot: a number of units of a single commodity, identifiable by its homogeneity of composition and origin;
(j)
Laboratory: a public - or private - law entity carrying out analysis and proper diagnosis, enabling the producer to monitor production quality.
Article 4
In accordance with the procedure laid down in Article 22, a schedule shall be established for each genus or species referred to in the Annex, with a reference to the plant health conditions laid down in Directive 77/93/EEC applying to the genus or species concerned, and laying down:
1. the conditions concerning the quality with which propagating material and ornamental plants must comply, in particular those related to the propagation system applied, the purity of the growing crop and, where appropriate, varietal characteristics;
2.
the conditions with which rootstocks of other genera and species must comply if material of the genus or species concerned is grafted onto them.
Article 5
1. Member States shall ensure that suppliers take all the necessary measures to guarantee compliance with the standards set by this Directive at all stages of the production and marketing of ornamental-plant-propagating material and ornamental plants.
2. To that end, the said suppliers shall either carry out themselves, or have carried out by an accredited supplier or the responsible official body, checks based on the following principles:
- identification of critical points in their production process on the basis of the production methods used,
- establishment and implementation of methods for monitoring and checking the critical points referred to in the first indent,
- taking samples for analysis in a laboratory accredited by the responsible official body for the purpose of checking compliance with the standards established by this Directive,
- keeping a written record, or a record registered in an indelible fashion, of the data referred to in the first, second and third indents, as well as records on production and marketing of propagating material and ornamental plants, to be held at the disposal of the responsible official body. These documents and records shall be kept for a period of at least one year.
However, suppliers whose activity in this connection is confined merely to the distribution of propagating material and ornamental plants produced and packaged on premises other than their own shall be required only to keep a written record or a record registered in an indelible fashion of the buying and selling and/or delivery of propagating material and ornamental plants.
This paragraph shall not apply to suppliers whose activity in this connection is confined to the supply of small quantities of propagating material and ornamental plants to non-professional final consumers.
3. If the results of their own checks or any information at the disposal of the suppliers referred to in paragraph 1 reveal the presence of one or more of the harmful organisms listed in the relevant schedules established pursuant to Article 4, the suppliers shall immediately report this to the responsible official body and shall carry out the measures indicated by that body. The supplier shall keep records of all occurrences of harmful organisms on his premises and of all measures taken in relation to such occurrences.
4. Rules for the application of the second subparagraph of paragraph 2 shall be established in accordance with the procedure laid down in Article 21.
Article 6
1. The responsible official body shall accredit suppliers once it has verified that their production methods and establishments meet the requirements of this Directive with regard to the nature of the activities they carry out. The accreditation must be renewed if a supplier decides to carry out activities other than those for which he has received accreditation.
2. The responsible official body shall accredit laboratories once it has verified that these laboratories, their methods and their establishments meet the requirements of this Directive to be specified according to the procedure laid down in Article 21, with regard to the testing activities they carry out. The accreditation must be renewed if a laboratory decides to carry out activities other than those for which it has received accreditation.
3. The responsible official body shall take the necessary measures if the requirements referred to in paragraphs 1 and 2 cease to be met. To this end, it shall take particular account of the conclusions of any check carried out in accordance with Article 7.
4. The supervision and monitoring of suppliers, establishments and laboratories shall be carried out regularly by or under the responsibility of the responsible official body, which shall at all times have free access to all parts of establishments, in order to ensure compliance with the requirements of this Directive. Implementing measures concerning supervision and monitoring may be adopted, in accordance with the procedure laid down in Article 21.
If such supervision and monitoring reveal that the requirements of this Directive are not being met, the responsible official body shall take appropriate action.
Article 7
1. Experts from the Commission may, in cooperation with the responsible official bodies of the Member States, make on-the-spot checks in so far as this is necessary to ensure the uniform application of this Directive. They may in particular verify whether suppliers are in effect complying with the requirements of this Directive. A Member State in whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the Member States of the results of the investigations.
2. Detailed rules for the application of paragraph 1 shall be adopted in accordance with the procedure laid down in Article 21.
Article 8
1. Propagating material or ornamental plants shall not be placed on the market except by accredited suppliers and unless they meet the requirements for propagating material and ornamental plants laid down in the schedule referred to in Article 4.
2. Without prejudice of Directive 77/93/EEC, paragraph 1 shall not apply to propagating material or ornamental plants intended for:
(a) trials or scientific purposes;
(b)
selection work.
Article 9
1. Propagating material and ornamental plants shall be marketed with a reference either to the variety or to the group of plants to which they belong.
2. The varieties to which reference is made pursuant to paragraph 1 shall be:
- either commonly known, and protected in accordance with provisions on the protection of new varieties of plants, officially registered on a voluntary or other basis,
- or entered on lists kept by suppliers, with their detailed descriptions and relevant denominations. These lists must be accessible, upon request, to the responsible official body of the Member State concerned.
Each variety shall be described and, as far as possible, bear the same denomination in all the Member States, in accordance with accepted international guidelines.
3. Where reference is made to a group of plants, the supplier should describe and quote the denomination of the group of plants in such a way as to avoid confusion with any of the varieties referred to in paragraph 2.
4. Except where the varietal aspect is explicitly mentioned in the schedules referred to in Article 4, paragraphs 1, 2 and 3 shall not mean any extra responsibility for the responsible official body.
5. A system for the notification of varieties or other groups of plants to the responsible official bodies of the Member States may be set up in accordance with the procedure laid down in Article 21. Additional implementing provisions for the second indent of paragraph 2 may be adopted in accordance with the same procedure.
Article 10
1. While growing and during lifting or removal from the parent material, propagating material or ornamental plants shall be kept in separate lots.
2. If propagating material or ornamental plants of different origins are put together or mixed during packaging, storage, transport or at delivery, the supplier shall keep records including the following data: composition of the lot and origin of the individual components.
3. Member States shall ensure compliance with the requirements referred to in paragraphs 1 and 2 by carrying out official inspections.
Article 11
Without prejudice to Article 10 (2), propagating material and ornamental plants shall be marketed only in sufficiently homogeneous lots.
Propagating material and ornamental plants shall in all cases satisfy the requirements of this Directive and shall be accompanied by a document made out by the supplier in accordance with the conditions laid down in the schedule established pursuant to Article 4. If an official statement appears on this document, it shall be clearly separated from all other contents of the document.
If appropriate, requirements on propagating material and/or ornamental plants for labelling and/or sealing and packaging shall be included in the schedule established pursuant to Article 4.
In the case of retail supply of propagating material or ornamental plants to a non-professional final consumer, requirements on labelling may be confined to appropriate product information.
Article 12
Member States may exempt
- from the application of Article 11, small producers all of whose production and sales of propagating material and ornamental plants is intended for final use by persons on the local market who are not professionally involved in plant production ('local circulation`),
- from the official control provided for in Article 18, the local circulation of propagating materials and ornamental plants produced by such exempt persons.
In accordance with the procedure laid down in Article 21, implementing measures relating to other requirements concerning the exemptions referred to in the first and second indents above, in particular as regards the concepts of 'small producers` and 'local market`, and to the relevant procedures, shall be adopted.
Article 13
In the event of temporary difficulties in the supply of propagating material or ornamental plants satisfying the requirements of this Directive, rules may be adopted, in accordance with the procedure laid down in Article 21, concerning the marketing of propagating material and ornamental plants meeting less stringent requirements, without prejudice to the plant-health rules laid down in Directive 77/93/EEC.
Article 14
The marketing of propagating material and ornamental plants which comply with the requirements and conditions of this Directive shall be subject to no restrictions as regards supplier, plant health, growing medium and inspection arrangements, other than those laid down in this Directive.
Article 15
As concerns the products referred to in the Annex, Member States shall refrain from imposing more stringent conditions or marketing restrictions other than the conditions laid down in the schedules established pursuant to Article 4 or those obtaining on the date of adoption of this Directive as the case may be.
Article 16
1. In accordance with the procedure laid down in Article 21, it shall be decided whether propagating material and ornamental plants produced in a third country and affording the same guarantees as regards obligations on the supplier, identity, characteristics, plant health, growing medium, packaging, inspection arrangements, marking and sealing, are equivalent in all these respects to propagating material and ornamental plants produced in the Community and complying with the requirements and conditions of this Directive.
2. Pending the decision referred to in paragraph 1, Member States may, until 1 January 1993, apply to the import of propagating material and ornamental plants from third countries conditions equivalent to those applicable to the production and marketing of products obtained in the Community.
In accordance with the procedure laid down in Article 21, the date referred to in the first subparagraph may, for the various third countries, be put back pending the decision referred to in paragraph 1.
Propagating material and ornamental plants imported by a Member State in accordance with a decision taken by that Member State pursuant to the first subparagraph shall be subject to no marketing restrictions as regards the matters referred to in paragraph 1 in other Member States.
Article 17
Member States shall ensure that propagating material and ornamental plants are officially inspected during production and marketing, at least by random checks, to verify compliance with the requirements and conditions of this Directive.
Article 18
Detailed implementing procedures for the official inspection referred to in Articles 5, 10 and 17, including sampling methods, may be established in accordance with the procedure laid down in Article 21.
Article 19
1. If, during the supervision and monitoring referred to in Article 6 (4), the official inspection referred to in Article 17, or the trials referred to in Article 20, it is found that propagating material or ornamental plants do not meet the requirements of this Directive, the responsible official body of the Member State shall take appropriate action to ensure that they do comply with the provisions of this Directive or, if that is not possible, to ban the marketing of that propagating material or those ornamental plants in the Community.
2. If it is found that propagating material or ornamental plants marketed by a particular supplier do not comply with the requirements and conditions of this Directive, the Member State concerned shall ensure that appropriate measures are taken against that supplier. If the supplier is forbidden to market propagating material and ornamental plants, the Member State shall notify the Commission and the competent national bodies in the Member States.
3. Any measures taken under paragraph 2 shall be withdrawn as soon as it has been established with adequate certainty that the propagating material or ornamental plants intended for marketing by the supplier will, in future, comply with the requirements and conditions of this Directive.
Article 20
1. Trials, or where appropriate tests, shall be carried out in the Member States on samples to check that propagating material or ornamental plants comply with the requirements and conditions of this Directive, including those relating to plant health. The Commission may organize inspections of the trials by representatives of the Member States and of the Commission.
2. It may be decided in accordance with the procedure laid down in Article 21 that it is necessary to carry out Community trials or tests for the same purpose as mentioned in paragraph 1. The Commission may organize inspections of Community trials by representatives of the Member States and of the Commission.
3. The trials or tests referred to in paragraphs 1 and 2 shall be used to harmonize technical methods of examination of propagating material and ornamental plants. Progress reports shall be made on the trials or tests and sent in confidence to the Member States and to the Commission.
4. The Commission shall ensure that, in appropriate cases, arrangements for coordinating, carrying out and inspecting the trials referred to in paragraphs 1 and 2, and assessing their results, are made within the Committee set up by Article 21. When plant health problems occur, the Commission shall notify the Standing Committee on Plant Health. If necessary, specific arrangements shall be adopted. Propagating material and ornamental plants produced in third countries shall be included in the trials.
Article 21
Where reference is made to the procedure laid down in this Article, the Commission shall be assisted by a Committee, referred to as the Standing Committee for Propagating Material and Ornamental Plants, chaired by a representative of the Commission.
The representative of the Commission shall submit to the Standing Committee a draft of the measures to be taken. The Standing Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the EEC Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the Standing Committee, they shall be communicated by the Commission to the Council forthwith. In that event, the Commission may defer application of the measures which it has decided for a period of not more than one month from the date of such communication.
The Council, acting by a qualified majority, may take a different decision within the time referred to in the previous paragraph.
Article 22
Where reference is made to the procedure laid down in this Article, the Commission shall be assisted by the Standing Committee for Propagating Materials and Ornamental Plants, chaired by the representative of the Commission.
The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the EEC Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 23
Amendments to the schedules established pursuant to Article 4 and to the conditions and detailed rules adopted for the implementation of this Directive shall be adopted in accordance with the procedure laid down in Article 21.
Article 24
1. Member States shall ensure that propagating material and ornamental plants produced in their territory and intended for marketing comply with the requirements of this Directive.
2. If it is found, at an official inspection, that propagating material or ornamental plants cannot, by reason of non-compliance with a condition relating to plant health, be placed on the market, the Member State concerned shall take appropriate official measures to eliminate any consequent plant-health risk.
Article 25
1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 31 December 1992. They shall forthwith inform the Commission thereof.
When these measures are adopted by the Member States, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods for making such reference shall be adopted by the Member States.
2. As far as Articles 5 to 11, 14, 15, 17, 19 and 24 are concerned, the date of application for each genera or species referred to in the Annex shall be adopted in accordance with the procedure provided for in Article 21, when the schedule referred to in Article 4 is drawn up. These dates may not fall after 1 January 1993.
Article 26
This Directive is addressed to the Member States. | [
"UKSI19952651"
] |
31991L0683 | 1991 | Council Directive 91/683/EEC of 19 December 1991 amending Directive 77/93/EEC on protective measures against the introduction into the Member States of organisms harmful to plants or plant products
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas by Directive 77/93/EEC (4), as last amended by Directive 91/27/EEC (5), the Council laid down protective measures against the introduction into the Member States of organisms harmful to plants or plant products; whereas the protection of plants against such organisms is absolutely necessary to increase agricultural productivity, which is one of the objectives of the common agricultural policy;
Whereas the completion of the internal market at the end of 1992 will entail the application of the Community plant health regime established by Directive 77/93/EEC, with effect from that time, to the Community as an area without internal frontiers; whereas it is furthermore considered that areas which are not affected by particular harmful organisms need protection wherever they are located in the Community; whereas, accordingly, the scope of the regime should no longer be restricted to trade between Member States and third countries, but should also be extended to marketing within single Member States;
Whereas, in principle, all parts of the Community should benefit from the same degree of protection against harmful organisms; whereas, however, differences in ecological conditions and in the distribution of certain harmful organisms must be taken into account; whereas, in consequence, 'protected zones` exposed to particular plant health risks should be defined and should be accorded special protection under conditions compatible with the internal market;
Whereas to ensure more effective application of the Community plant-health regime in the internal market, it must be possible to use, for the purpose of plant-health checks, available official manpower other than that of Member States' official plant-protection organizations, whose training shall be coordinated and supported financially by the Community;
Whereas the application of the Community plant health regime to the Community as an area without internal frontiers, and the introduction of protected zones will necessitate a restructuring, based in particular on a more realistic assessment of plant health risks arising from Community products, of the requirements laid down in the Annexes to Directive 77/93/EEC, so as to classify them as applicable to Community products on the one hand and to imports from third countries on the other, and to identify harmful organisms relevant for protected zones; whereas this restructuring should lead to a simplification of the Annexes, in particular by the removal of a number of harmful organisms established in certain parts of the Community and the related requirements;
Whereas some of this restructuring should be entrusted to the Commission assisted by the Standing Committee on Plant Health established by Decision 76/894/EEC (6);
Whereas in the context of the internal market it must be possible to rely on plant health checks carried out in consignor Member States; whereas it is accordingly necessary to establish more detailed and more uniform rules for these checks;
Whereas the most appropriate place for carrying out plant-health checks is the place of production; whereas, in respect of Community products, these checks must therefore be made mandatory at the place of production and should extend to all relevant plants and plant products grown, produced, used or otherwise present there, and to the growing medium used there; whereas, for the efficient operation of such a system of checks, all producers should be officially registered;
Whereas, if the results of the checks are satisfactory, instead of the phytosanitary certificate used in international trade, an agreed mark ('plant passport`), adapted to the type of product, should be attached to the product, in order to ensure its free movement throughout the Community or those parts thereof for which it is valid;
Whereas the official measures to be taken when the results of the checks are not satisfactory should be specified;
Whereas, to ensure compliance with the Community plant-health regime in the context of the internal market, a system of official checks during marketing should be established; whereas this system should be as reliable and uniform as possible throughout the Community but should exclude specific controls at borders between Member States;
Whereas, as from completion of the internal market, products originating in third countries should in principle be subjected to plant health checks on first introduction into the Community; whereas, if the results of the checks are satisfactory, third country products should be issued with a plant passport, ensuring free movement, in the same way as Community products;
Whereas, in order to confront the new situation created by the completion of the internal market with the necessary guarantees, it is essential to reinforce the plant-health infrastructure at national and Community level at the Community's external frontiers, paying particular attention to those Member States which, by reason of their geographical situation, are points of entry to the Community; whereas the Commission will propose the inclusion in the General Budget of the European Communities of the necessary appropriations for that purpose;
Whereas, with a view to improving the efficiency of the Community plant health regime in the context of the internal market, the Member States should standardize the practices of the personnel responsible for plant health; whereas the Commission will submit, before 1 January 1993, a Community code of plant health practice;
Whereas it should no longer be possible for Member States to adopt any special plant-health provisions on the introduction into their territory of plants or plant products originating in other Member States; whereas all provisions on plant health requirements for plants and plant products should be established at Community level; whereas Article 18 (2) of Directive 77/93/EEC should therefore be deleted and replaced by a simplified procedure for establishing the coherence of the provisions of the Directive with other Community provisions on plant health requirements,
Article 1
Directive 77/93/EEC is hereby amended as follows:
1. The title shall be replaced by the following:
'Council Directive of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community`.
2.
In Article 1, the following paragraphs shall be added:
'5. With effect from 1 January 1993, this Directive shall also concern protective measures against the spread of harmful organisms within the Community by means related to movements of plants, plant products and other related objects within a Member States.
6. Each Member State shall establish or designate one single and central authority responsible, under the control of the national government, in particular for coordination and contacts in matters related to plant health within the context of this Directive. The official plant protection service set up under the International Plant Protection Convention (IPPC) shall preferably be designated for this purpose. This authority and any subsequent change shall be notified to the other Member States and to the Commission.`
3.
In Article 2 (1), point (f) shall be replaced by the following points:
'(f) plant passport: shall be considered to mean an official label which gives evidence that the provisions of this Directive related to plant health standards and special requirements are satisfied, and which is:
- standardized at Community level for different types of plants or plant products, and
- prepared by the responsible official body in a Member State and issued in accordance with the implementing rules governing the details of the procedure for issuing plant passports.
For specific types of product, official agreed marks other than a label may be decided on in accordance with the procedure laid down in Article 16a.
The standardization shall be established in accordance with the same procedure. Under this standardization, different marks shall be determined for plant passports which are not valid, in accordance with the second subparagraph, of Article 10 (1), for all parts of the Community.
(g)
The responsible official bodies in a Member State shall be:
(a) the official plant protection service(s) of a Member State referred to in Article 1 (6); or
(b)
any State authority established
- at national level,
- or, under the supervision, within the limits set by the constitution of the Member State concerned, of national authorities, at regional level,
The bodies referred to in the first subparagraphs (a) and (b) may, in accordance with national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to any legal person, whether governed by public or by private law, which under its officially approved constitution is charged exclusively with specific public functions, provided that such person, and its members, has no personal interest in the outcome of the measures it takes.
The Member States shall ensure that there is close cooperation between the bodies referred to in the first subparagraph (b) and those referred to in (a).
Moreover, in accordance with the procedure laid down in Article 16a, other legal persons established on behalf of the body(ies) referred to in the first subparagraph (a) and acting under the authority and supervision of such body may be approved, provided that such person has no personal interest in the outcome of the measures it takes.
The single central authority referred to in Article 1 (6) shall inform the Commission of the responsible official bodies in the Member State concerned. The Commission shall forward that information to the other Member States.`
4.
In Article 2 (1) the following points shall be added:
'(h) protected zone: shall be considered to mean a zone in the Community:
- in which one or more harmful organisms referred to in this Directive, which are established in one or more parts of the Community, are not endemic or established, despite favourable conditions for them to establish there,
- in which there is a danger that certain harmful organisms will establish themselves, given propitious ecological conditions, for particular crops, despite the fact that these organisms are not endemic or established in the Community,
and which has been recognized, in accordance with the procedure laid down in Article 16a, as fulfilling the conditions set out in the first and second indents and, in the case referred to in the first indent, at the request of the Member State(s) concerned and on the grounds that the results of appropriate surveys which have been monitored by the experts referred to in Article 19a under the procedure laid down therein show no evidence to the contrary. Surveys in the eventuality referred to in the second indent are optional.
A harmful organism shall be considered to be established in an area if it is known to occur there and if either no official measures have been taken there with a view to its eradication or such measures have proved, for a period of at least two successive years, to be ineffective.
The Member State(s) concerned shall conduct, with respect to the case provided for in the first indent of the first subparagraph, regular and systematic official surveys on the presence of organisms in respect of which the protected zone has been recognized. Each finding of such organisms shall immediately be notified to the Commission. The risk arising from such finding shall be assessed by the Standing Committee on Plant Health and appropriate action decided on in accordance with the procedure referred to in Article 16a.
The details of the surveys referred to in the first and third subparagraphs may be established in accordance with the said procedure, account being taken of sound scientific and statistical principles.
The results of the above surveys shall be notified to the Commission. The Commission shall forward this information to the other Member States.
The Commission shall, before 1 January 1998, submit a report to the Council on the operation of the system of protected zones together, if necessary, with any appropriate proposals;
(i)
a statement or measure shall be considered to be official if made or taken, without prejudice to the provisions of Article 19a:
- by representatives of the official plant protection organization of a Member State or, under their responsibility, by other public servants, in the case of statements or measures related to the issuing of the certificates specified in Article 7 (1) or Article 8 (2);
- either by such representatives or public servants or by "qualified agents" employed by one of the responsible official bodies as specified in (f) of a Member State, in all other cases, provided that such agents have no personal interest in the outcome of the measures they take, and satisfy minimum standards of qualification.
Member States shall ensure that their public servants and qualified agents have the qualifications necessary for the proper operation of this Directive. In accordance with the procedure laid down in Article 16a, guidelines may be established for such qualifications.
The Commission shall, acting within the Standing Committee on Plant Health, draw up Community programmes, the implementation of which it shall monitor, regarding the further training of the public servants and qualified agents concerned, in an effort to raise the knowledge and experience acquired at national level to the level of the aforementioned qualifications. It shall contribute to the financing of this further training and shall propose the inclusion of the necessary appropriations for that purpose in the Community budget.`
5.
In Article 3, paragraphs 4, 5, 6 and 7 shall be replaced by the following:
'4. With effect from 1 January 1993, Member States shall provide that paragraphs 1 and 2 shall be applied also to the spread of the harmful organisms concerned by means connected with the movement of plants, plant products or other objects within the territory of a Member State.
5. Member States shall ban from the same date the introduction into, and the spread within the relevant protected zones, of:
(a) the harmful organisms listed in Annex I, part B;
(b)
the plants and plant products listed in Annex II, part B, where they are contaminated by the relevant harmful organisms listed therein.
6. In accordance with the procedure laid down in Article 16a:
(a) the harmful organisms listed in Annexes I and II shall be subdivided as follows:
- organisms not known to occur in any part of the Community and relevant for the entire Community shall be listed in Annex I, part A, section I and Annex II, part A, section I respectively,
- organisms known to occur in the Community but not endemic or established throughout the Community and relevant for the entire Community shall be listed in Annex I, part A, section II and Annex II, part A, section II respectively,
- the other organisms shall be listed in Annex I, part B, and Annex II, part B, respectively, against the protected zone for which they are relevant;
(b)
harmful organisms endemic or established in one or more parts of the Community shall be deleted, save those referred to in the second and third indents of point (a);
(c)
the titles of Annexes I and II, as well as the different parts and sections thereof, shall be adapted to the above.
7. In accordance with the procedure laid down in Article 16a, it may be decided that Member States shall lay down that the introduction into their territories, and the spread within their territories, of specified organisms, whether singly or not, which are considered to be harmful to plants or plant products but are not listed in Annexes I and II, shall be prohibited or require special authorization under conditions specified under the same procedure.
This provision shall also apply to such organisms where they are not affected by Directive 90/220/EEC (*) or other more specific Community provisions regarding genetically modified organisms.
(*) OJ N° L 117, 8. 5. 1990, p. 15.`
6. Article 4 (2) (a) shall be replaced by the following:
'(a) The Member States shall provide that, from 1 January 1993, the introduction of plants, plant products and other objects listed in Annex III, part B, into the relevant protected zones located in their territory is prohibited.`
7. In Article 4, the following paragraphs shall be added:
'3. In accordance with the procedure laid down in Article 16a, Annex III shall be revised in such a way that part A contains plants, plant products and other objects which constitute a plant-health risk for all parts of the Community, and part B contains plants, plant products and other objects which constitute a plant-health risk only for protected zones. The protected zones shall be specified there respectively.
4. With effect from 1 January 1993, paragraph 1 shall no longer apply to plants, plant products and other objects originating in the Community, and paragraph 2 (b) shall be deleted.`
8.
In Article 5, the second sentence of paragraph 1 shall be deleted.
9.
Article 5 (2) shall be replaced by the following:
'2. Member States shall ban from 1 January 1993 the introduction into and the movement within the protected zones of the plants, plant products and other objects listed in Annex IV, part B, unless the relevant special requirements indicated in that part of the Annex are met.`
10.
In Article 5, the following paragraphs shall be added:
'3. In accordance with the procedure laid down in Article 16a, Annex IV shall be amended in accordance with the criteria laid down in Article 3 (6).
4. With effect from 1 January 1993, Member States shall provide that paragraph 1 shall also apply to the movement of plants, plant products and other objects within the territory of a Member State, without prejudice however to Article 6 (6).`
11.
In Article 6 (1) the words 'part A` shall be inserted after the words 'Annex V`.
12.
In Article 6, the following paragraph shall be inserted after paragraph 1:
'1a. As soon as the measures provided for in Article 3 (6) (a) and in Article 5 (3) are adopted, paragraph 1 shall apply only in respect of Annex I, part A, section II, Annex II, part A, section II and Annex IV, part A, section II. Where, in the course of the examination carried out in accordance with this provision, harmful organisms listed in Annex I, part A, section I or Annex II, part A, section I are detected, the conditions referred to in Article 10 are not deemed to be fulfilled.`
13.
In Article 6 (2), the terms 'Article 3 (5), (6) and (7)` shall be replaced by the terms 'Article 3 (4), (5) and (7)`.
14.
In Article 6, the following paragraphs shall be added:
'4. With effect from 1 January 1993, and without prejudice to paragraph 6, paragraphs 1, 2 and 3 shall also apply to the movement of plants, plant products and other objects within the territory of a Member State. Paragraphs 1, 2 and 3 shall not apply, as regards the harmful organisms listed in Annex I, part B, or Annex II, part B, and the special requirements set out in Annex IV, part B, to the movement of plants, plant products or other objects through or outside a protected zone.
The official examinations referred to in paragraphs 1, 2 and 3 shall be carried out in accordance with the following provisions:
(a) They shall extend to the relevant plants or plant products grown, produced or used by the producer or otherwise present on his premises as well as to the growing medium used there.
(b)
They shall be made on the premises, preferably at the place of production.
(c)
They shall be made regularly at appropriate times, at least once a year, and at least by visual observation, without prejudice to the special requirements listed in Annex IV; further action may be taken where this is provided for under paragraph 7.
Any producer for whom the official examination referred to above is required under paragraphs 1 to 4 shall be listed in an official register under a registration number by which to identify him. The official registers thus established shall be accessible to the Commission on request.
The producer is subject to certain obligations established in accordance with paragraph 7. In particular, he shall immediately notify the responsible official body of the Member State concerned of any unusual occurrence of harmful organisms, symptoms or any other plant abnormality.
5. With effect from 1 January 1993, Member States shall provide that producers of certain plants, plant products or other objects not listed in Annex V, part A, specified in accordance with paragraph 7, or collective warehouses or dispatching centres in the production zone, shall also be listed in an official local, regional or national register in accordance with the last subparagraph of paragraph 4. They may at any time be subjected to the examinations provided for in the second subparagraph of paragraph 4.
In accordance with paragraph 7, a system may be set up so that certain plants, plant products and other objects may if necessary and in so far as possible, be traced back to their origins, bearing in mind the nature of the production or trading conditions.
6. Member States may, in so far as no spreading of harmful organisms is to be feared, exempt
- small producers or processors whose entire production and sale of relevant plants, plant products and other objects are intended for final usage by persons on the local market, and who are not professionally involved in plant production ('local movement`), from official registration as laid down in paragraphs 4 and 5, or
- the local movement of plants, plant products and other objects originating from producers so exempted from the official examination required under paragraphs 4 and 5.
14.
The provisions of this Directive on local movement shall be reviewed by the Council before 1 January 1998 on the basis of a Commission proposal and in the light of experience gained.
7. In accordance with the procedure laid down in Article 16a, implementing provisions relating to:
- less stringent conditions on the movement of plants, plant products and other objects within a protected zone established for the said plants, plant products and other objects in respect of one or more harmful organisms,
- guarantees in respect of the movement of plants, plant products and other objects through a protected zone established for the said plants, plant products and other objects in respect of one or more harmful organisms,
- the frequency and timing of the official examination, including further action referred to in paragraph 4, second subparagraph, (c),
- the obligations on registered producers referred to in paragraph 4, last subparagraph,
- the specification of the products referred to in paragraph 5, and the products for which the system introduced in paragraph 5 is envisaged,
- other requirements regarding the exemption referred to in paragraph 6, in particular as regards the concepts of "small producer" and "local market" and the relevant procedures
shall be adopted.
14.
8. Implementing rules related to the registration procedure and the registration number referred to in paragraph 4, last subparagraph may be adopted in accordance with the procedure laid down in Article 16a.
9. Member States may apply paragraphs 4, 5 and 6 in advance of 1 January 1993, either wholly or in relation to certain regions or certain groups of plants or plant products.
In such cases, the Member States concerned shall immediately inform the Commission and the other Member States of the provisions adopted for that purpose'.
15.
In Article 7 (2) and Article 8 (1), 'part A` shall be inserted after 'Annex V`.
16.
After Article 9, the following Articles shall be inserted:
'Article 10
1. With effect from 1 January 1993, where it is considered, on the basis of the examination provided for in Article 6 (1), (2) and (3) and carried out in accordance with Article 6 (4), that the conditions of those paragraphs are fulfilled, a plant passport shall be issued in accordance with provisions which may be adopted under paragraph 4, instead of the phytosanitary certificates referred to in Articles 7 or 8.
If the examination does not concern conditions relevant to the protected zones, or if it is considered that such conditions are not fulfilled, the plant passport issued shall not be valid for those zones and it shall have the mark reserved for such cases, pursuant to Article 2
(1) (f).
2. (a) With effect from 1 January 1993, plants, plant products and other objects listed in Annex V, part A, section I, may not be moved within the Community, other than locally within the meaning of Article 6 (6), unless a plant passport valid for the territory concerned and issued in accordance with paragraph 1 is attached to them, to their packaging or to the vehicles transporting them.
(b)
With effect from 1 January 1993, plants, plant products and other objects listed in Annex V, part A, section II, may not be introduced into a specified protected zone or move therein, unless a plant passport valid for that zone and issued in accordance with paragraph 1 is attached to them, to their packaging or to the vehicles transporting them. If the conditions laid down in Article 6 (7) with regard to transport through protected zones are fulfilled, this paragraph shall not apply.
3. A plant passport may be replaced at a later date and in any part of the Community by another plant passport, in accordance with the following provisions:
- a plant passport may be replaced only where consignments are divided up or where several consignments or parts thereof are combined or where the plant-health status of consignments changes, without prejudice to the particular requirements provided for in Annex IV, or in other cases specified in accordance with paragraph 4,
- the replacement may take place only at the request of a natural or legal person, whether a producer or not, listed in an official register, in accordance with Article 6 (4) third subparagraph, mutatis mutandis,
- the replacement passport may be prepared only by the responsible official body of the area in which the requesting premises are situated and only if the identity of the product concerned and the absence of any risk of infection due to harmful organisms listed in Annexes I and II since dispatch by the producer can be guaranteed,
- the replacement procedure must comply with the provisions which may be adopted under paragraph 4,
- the replacement passport must bear a special mark, stipulated in accordance with paragraph 4 and including the number of the original producer and, if there was a change in plant-health status, of the operator responsible for that change.
4. In accordance with the procedure laid down in Article 16a, implementing provisions may be adopted for:
- the detailed procedures for issuing plant passports as laid down in paragraph 1,
- the conditions under which a plant passport may be replaced in accordance with paragraph 3, first indent,
- the details of the procedure for the replacement passport as laid down in paragraph 3, third indent,
- the special mark required for the replacement passport as laid down in paragraph 3, fifth indent.
5. Member States which make use of Article 6 (9) may issue plant passports in accordance with paragraph 1, in advance of 1 January 1993, without prejudice to the provisions on the issue of phytosanitary certificates.
Article 10a
1. Where it is not considered, on the basis of the examination provided for in Article 6 (1) (2), and (3) and carried out in accordance with Article 6 (4), that the conditions in those paragraphs are fulfilled, a plant passport shall not be issued, without prejudice to paragraph 2.
2. In the special cases where it is established, taking into account the nature of the findings made in the examination concerned, that part of the plants or plant products grown, produced or used by the producer or otherwise present on his premises, or part of the growing medium used there, cannot present any risk of spreading harmful organisms, paragraph 1 shall not apply to that part.
3. To the extent that paragraph 1 applies, the plants, plant products or growing medium concerned shall be the subject of one or more of the following official measures:
- appropriate treatment, followed by the issue of the appropriate plant passport in accordance with Article 10 if it is considered that, as a result of the treatment, the conditions are fulfilled,
- a permit for movement, under official control, to zones where they do not present an additional risk,
- a permit for movement, under official control, to places for industrial processing,
- destruction.
In accordance with the procedure laid down in Article 16a, implementing provisions may be adopted concerning:
- the conditions under which one or more of the above measures must or must not be adopted,
- the particular features of and conditions for such measures.
4. To the extent that paragraph 1 applies, the activities of the producer shall be totally or partially suspended until it is established that the risk of spreading harmful organisms is eliminated. As long as this suspension lasts, the relevant provisions of Article 10 shall not apply.
5. Where it is considered, on the basis of the official examination carried out in accordance with Article 6 (5), that products referred to therein are not free of the harmful organisms listed in Annexes I and II, paragraphs 2, 3 and 4 shall apply mutatis mutandis.`
17.
In Article 11, the following paragraphs shall be added:
'7. With effect from 1 January 1993, paragraphs 1, 3 and 3a shall no longer apply and Member States shall instead organize official checks to ensure compliance with the provisions of this Directive, in particular with Article 10 (2), which shall be carried out at random and without any discrimination in respect of the origin of the plants, plant products or other objects, and in accordance with the following provisions:
- occasional checks, at any time and at any place where plants, plant products or other objects are moved,
- occasional checks on premises where plants, plant products or other objects are grown, produced, stored or offered for sale, as well as on the premises of purchasers,
- occasional checks at the same time as any other documentary check which is carried out for reasons other than plant health.
The checks must be regular in premises listed in an official register in accordance with Article 10 (3) and Article 12 (6) and may be regular in premises listed in an official register in accordance with Article 6 (5).
The checks may be regular and may be targeted if facts have come to light to suggest that one or more provisions of this Directive have not been complied with.
8. Commercial purchasers of plants, plant products or other objects shall, as final users professionally engaged in plant production, retain the related plant passports for at least one year, and make references to them in their records.
Inspectors shall have access to the plants, plant products or other objects at any stage in the production and marketing chain. They shall be entitled to make any investigation necessary for the official checks concerned, including those related to the plant passports and the records.
9. The Member States may be assisted in the official checks by the experts referred to in Article 19a.
10. Where it is established, through the official checks carried out in accordance with paragraphs 7 and 8, that plants, plant products or other objects present a risk of spreading harmful organisms, they shall be the subject of official measures in accordance with Article 10a (3).`
18.
In Article 12 (1) and (3a), 'part B` shall be inserted after 'Annex V`.
19.
In Article 12 (1) (b), the references to Articles 4, 5 and 9 shall be deleted.
20. In Article 12, the following paragraphs shall be added:
'6. With effect from 1 January 1993, paragraph 1 (a) shall apply, in cases of consignments to a protected zone, to harmful organisms and to the special requirements listed in part B of Annexes I, II and IV respectively. With effect from the same date, paragraphs 3 and 4 shall be deleted. With effect from the same date, paragraph 1 shall apply on the occasion of the first introduction of the plants, plant products or other objects concerned into the Community, without prejudice to specific agreements concluded in this respect between the Community and certain third countries.
Member States shall provide that importers, whether or not producers, must be included in an official register in accordance with Article 6 (4), mutatis mutandis.
The inspections, where they are documentary and identity checks and also checks intended to ensure compliance with the provisions of Article 4, must be made at the same place and at the same time as the other administrative formalities concerning import, including customs formalities.
The inspections, where they are plant-health checks, shall be carried out at the places where the inspections are carried out as referred to in the previous subparagraph or near to those places. The competent authorities of the Member States shall forward to the Commission and the other Member States the list of points of entry. However, in these particular cases, plant-health checks may be carried out at the place of destination as long as specific guarantees as regards the transport of the plants, plant products and other objects are provided. Implementing provisions, which may stipulate minimum conditions, shall be adopted in accordance with the procedure laid down in Article 16a. Plant-health checks shall be regarded as being an integral part of the formalities referred to in the previous subparagraph.
Member States may derogate from these provisions only under the conditions laid down as part of the technical arrangements referred to in paragraph 5.
7. With effect from 1 January 1993, Article 10 (1) and (3) shall apply in the same way to the plants, plant products or other objects referred to in paragraph 1 of this Article in so far as they are listed in Annex V, part A, and where it is considered, on the basis of the inspection laid down in paragraph 6, that the conditions referred to in paragraph 1 are fulfilled.
8. With effect from 1 January 1993, where it is not considered on the basis of the inspections provided for in paragraph 6, that the conditions referred to in paragraph 1 are fulfilled, one or more of the following official measures shall be taken immediately:
- appropriate treatment where it is considered that, as a result of the treatment, the conditions are fulfilled,
- removal of infected/infested produce from the consignment,
- imposition of a quarantine period until the results of the examinations or official tests are available,
- refusal or permission to send products to a destination outside the Community,
- destruction.
Article 10a (3), second subparagraph, shall apply mutatis mutandis`.
21.
In Article 14 (3), the following subparagraphs shall be added:
'Each authorization shall apply individually to all or part of the territory of the Community under conditions which take into account the risk of spreading harmful organisms by the product in question in protected zones taking into account the differences in agricultural and ecological conditions. In such cases, the Member States concerned shall be expressly exempted from the obligations derived from the above provisions in the decisions providing for the authorizations.
The risk shall be assessed on the basis of available scientific and technical information. Where such information is insufficient, it shall be supplemented by additional enquiries or, where appropriate, by investigations carried out by the Commission in the country of origin of the plants, plant products or other objects concerned.`
22.
The following paragraph shall be inserted into Article 15, and paragraphs 1, 2 and 3 of that Article becoming paragraphs 2, 3 and 4 respectively:
'1. Each Member State shall immediately notify the Commission and the other Member States of the presence in its territory of any of the harmful organisms listed in Annex I, part A, section I, or Annex II, part A, section I, or of the appearance in part of its territory in which their presence was previously unknown of any of the harmful organisms listed in Annex I, part A, section II or in part B, or in Annex II, part A, section II or in part B.
It shall take all necessary measures to eradicate, or if that is impossible, inhibit the spread of the harmful organisms concerned. It shall inform the Commission and the other Member States of the measures taken.`
23. In Article 15 (2) (a), the first sentence shall be replaced by the following:
'Each Member State shall immediately notify the Commission and the other Member States of the actual or suspected appearance of any harmful organisms not listed in Annex I or Annex II whose presence was previously unknown in its territory.`
24.
In Article 15 (2) (b), the terms 'referred to in (a)` shall be replaced by the terms 'referred to in paragraphs 1 and 2 (a).`
25.
In Article 15 (2) (c), the reference to 'paragraph 2` shall be replaced by a reference to 'paragraph 3`.
26.
In Article 15 (3) and (4), 'paragraph 1` shall be replaced in each case by 'paragraphs 1 and 2`.
27.
Article 18 (2) shall be replaced by the following:
'2. Amendments to this Directive which are necessary to establish coherence with Community provisions referred to in paragraph 1 shall be adopted in accordance with the procedure laid down in Article 16a.`
28.
Annex V shall be replaced by the following:
'ANNEX V
B. II.
A.
Plants, plant products and other objects originating in the Community.
A. I.
Plants, plant products and other objects which are potential carriers of harmful organisms of relevance for the entire Community.
A. II.
Plants, plant products and other objects which are potential carriers of harmful organisms of relevance for certain protected zones. Without prejudice to the plants, plant products and other objects listed in part A.I.
B.
Plants, plant products and other objects originating in territories other than those referred to in part A.
B. I.
Plants, plant products and other objects which are potential carriers of harmful organisms of relevance for the entire Community.
B. II.
Plants, plant products and other objects which are potential carriers of harmful organisms of relevance for certain protected zones. Without prejudice to the plants, plant products and other objects listed in part B. I.`
Article 2
The Council, acting by a qualified majority on a proposal from the Commission, shall adopt the revised version of Annex V to Directive 77/93/EEC before 1 July 1992.
Article 3
1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive six months after the revision of Annexes I to V to Directive 77/93/EEC. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication.
The methods of making such a reference shall be laid down by the Member States.
2. Member States shall immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19931320"
] |
31992L0002 | 1992 | Commission Directive 92/2/EEC of 13 January 1992 laying down the sampling procedure and the Community method of analysis for the official control of the temperatures of quick-frozen foods intended for human consumption
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 89/108/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to quick-frozen foods intended for human consumption (1), and in particular Article 11 thereof,
Whereas the temperature of quick-frozen foods should be controlled;
Whereas the Member States may use other methods scientifically valid provided that this does not hinder the free movement of quick-frozen foods and that the rules of competition are not altered;
Whereas after checking air temperature records according to procedures laid down in Commission Directive 92/1/EEC of 13 January 1992 on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption (2) and taking into account temperatures required in Article 5 of Directive 89/108/EEC, and where this leaves reasonable doubt, Member States may proceed to a destructive test;
Whereas the inspection conforms to Council Directive 89/397/EEC of 14 June 1989, concerning the official control of foodstuffs (3) and principally to its Articles 4 and 14;
Whereas the provisions provided for in this Directive are in line with the opinion of the Standing Committee on Foodstuffs,
Article 1
1. Member States shall ensure that the sampling procedure and the method of analysis needed for the official inspection of the temperatures of quick-frozen foods is carried out in accordance with the provisions described in Annexes I and II of this Directive.
2. However, the method of analysis described in Annex II of this Directive may be used only in the case where the inspection leaves reasonable doubts on the threshold of temperatures provided for in Directive 89/108/EEC on the approximation of the laws of the Member States relating to quick-frozen foods intended for human consumption.
Article 2
The introduction of requirements provided for in Article 1 (1) and Annexes I and II shall not preclude Member States from using other scientifically valid methods provided that this does not hinder the free movement of quick-frozen foods recognized as complying with the rules by virtue of the method described in Annex II of this Directive.
However, in the event of differences in the results, those obtained by the use of Community methods shall take precedence.
Article 3
1. Member States shall put into effect the laws, regulations and administrative provisions needed in order to comply with this Directive by, at the latest by 31 July 1993.
They shall forthwith inform the Commission thereof.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19940804",
"UKSI19940298"
] |
31992L0001 | 1992 | Commission Directive 92/1/EEC of 13 January 1992 on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 89/108/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to quick-frozen foods intended for human consumption (1), and in particular Article 11 thereof,
Whereas the legal provisions must, in this case, be restricted solely to the requirements that are necessary in order to meet essential and imperative needs regarding the monitoring of temperatures in means of transport, warehousing and storage in such a way as to ensure that the temperatures required by Article 5 of Directive 89/108/EEC are fully maintained;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
Article 1
This Directive concerns the monitoring of temperatures in the means of transport, warehousing and storage for quick-frozen foods.
Article 2
1. The means of transport, warehousing and storage must be fitted with suitable recording instruments to monitor, at frequent and regular intervals, the air temperatures to which quick-frozen foods intended for human consumption are subjected.
In the case of transport, the measuring instruments must be approved by the competent authorities of the country in which means of transport is registered.
Temperature recordings obtained in this manner must be dated and stored by the operator for at least one year or longer according to the nature of food.
2. The air temperature during storage in retail display cabinets, and in the course of local distribution, shall be measured by at least one easily visible thermometer which, in the case of open retail display cabinets, shall indicate the temperature at the air return side at the level of the clearly marked maximum load line.
3. Member States may permit a derogation from paragraph 1 in the case of cold chambers of less than 10 cubic metres for storing stock in retail outlets, so as to permit the air temperature to be measured by an easily visible thermometer.
Article 3
Member States shall bring into force the laws, regulations and administrative provisions needed in order to comply with this Directive by 31 July 1993, except for railways for which the date of implementation will be decided later.
They shall immediately inform the Commission thereof.
When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19940804",
"UKSI19940298"
] |
31992L0004 | 1992 | Commission Directive 92/4/EEC of 10 February 1992 amending Council Directive 78/663/EEC laying down specific criteria of purity for emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3 (3) thereof,
Whereas taking into account the specifications as adopted by the Codex Alimentarius and to take into account new production techniques, it is necessary to amend Council Directive 78/663/EEC (2), as last amended by Commission Directive 90/612/EEC (3);
Whereas, in pursuance of Article 6 of Directive 89/107/EEC, the Scientific Committee of Foodstuffs was consulted on the provisions likely to affect public health;
Whereas, the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
Article 1
The Annex to Directive 78/663/EEC is hereby amended as set out in the Annex to this Directive.
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 1993, at the latest, and shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The procedure for such reference shall be laid down by Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19931161"
] |
31992L0006 | 1992 | Council Directive 92/6/EEC of 10 February 1992 on the installation and use of speed limitation devices for certain categories of motor vehicles in the Community
Having regard to the Treaty establishing the European Economic Community, and in particular Article 75 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas one of the objectives of a common transport policy is to lay down common rules applicable to international transport within the Community and to facilitate the circulation of vehicles;
Whereas the growth of road traffic and the resulting increase in danger and nuisance present all Member States with road safety and environmental problems of a serious nature;
Whereas the available engine power for heavy goods vehicles and buses needed for climbing slopes enables them to be driven on level roads at excessive speeds that are not compatible with the specifications of other components of those vehicles such as brakes and tyres; whereas, for that reason and for reasons of environmental protection in certain Member States, speed limitation devices were made compulsory for certain categories of motor vehicles;
Whereas the beneficial effects of speed limitation devices with regard to protection of the environment and energy consumption, the wear and tear of the motor and tyres and road safety will be increased if such devices are in general use;
Whereas the use of speed limitation devices serves no purpose unless the appliances are of a degree of technical perfection such as will provide an adequate guarantee that no fraud is possible;
Whereas, as a first step, requirements should be introduced in the case only of the heaviest categories of motor vehicles which are most involved in international transport and thereafter, depending on technical possibilities and experiences in Member States, could be extended to lighter categories of motor vehicles;
Whereas, in certain Member States, vehicles intended exclusively for the carriage of dangerous goods must be equipped with speed limitation devices set at maximum speeds lower than those provided for by this Directive; whereas, in this specific case, the Member States in question should be allowed to maintain such regulations for vehicles registered within their territory because they enhance road safety and civil protection of the public, in accordance with the objectives of this Directive;
Whereas the installation of speed limitation devices on category M3 and N3 vehicles covered by this Directive, registered before it is brought into effect and intended exclusively for national transport operations could entail excessive costs in certain Member States; whereas it should therefore be made possible for those Member States to postpone the application of Articles 2 and 3 of this Directive to the vehicles concerned;
Whereas this Directive does not affect Member States' prerogatives as regards speed restriction provisions for traffic,
Article 1
For the purpose of this Directive, 'motor vehicle' means any power-driven vehicle falling within one of the categories listed below, intended for use on the road and having at least four wheels and a maximum design speed exceeding 25 km/h:
- category M3 vehicles having a maximum weight exceeding 10 metric tonnes,
- category N3 vehicles,
categories M3 and N3 being understood to be those defined in Annex I to Directive 70/156/EEC (4).
Article 2
Member States shall take the necessary steps to ensure that motor vehicles of the category M3 referred to in Article 1 shall be used on the road only if speed limitation devices are installed for which the maximum speed is set at 100 km/h.
Article 3
1. Member States shall take the necessary measures to ensure that motor vehicles of category N3 shall be used on the road only if equipped with a device set in such a way that their speed cannot exceed 90 km/h; bearing in mind the technical tolerance which is allowed, at the present state of technology, between the regulating value and the actual speed of traffic, the maximum speed on this device shall be set at 86 km/h.
2. Member States shall be authorized to set the maximum speed of the device at less than 85 km/h in vehicles used exclusively for the carriage of dangerous goods and registered in their territory.
Article 4
1. Articles 2 and 3 shall be applicable to vehicles registered as from 1 January 1994.
2. Articles 2 and 3 shall also be applicable, at the latest from 1 January 1995, to vehicles registered between 1 January 1988 and 1 January 1994.
However, where these vehicles are used exclusively for national transport operations, Articles 2 and 3 may be applied at the latest from 1 January 1996.
Article 5
1. Until Community provisions on these matters are applied, the speed limitation devices referred to in Articles 2 and 3 must satisfy the technical requirements laid down by the competent national authorities.
2. Speed limitation devices shall be installed by workshops or bodies approved by the Member States.
Article 6
The requirements of Articles 2 and 3 do not apply to motor vehicles used by armed forces, civil defence, fire and other emergency services and forces responsible for maintaining public order.
The same shall apply for motor vehicles which:
- by their construction, cannot drive faster than the limits provided for in Articles 2 and 3,
- are used for scientific tests on roads,
- are used only for public services in urban areas.
Article 7
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 October 1993. They shall immediately inform the Commission thereof.
When these provisions are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for making such reference shall be adopted by Member States.
2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.
Article 8
This Directive is addressed to the Member States. | [
"UKSI19971340"
] |
31992L0005 | 1992 | Council Directive 92/5/EEC of 10 February 1992 amending and updating Directive 77/99/EEC on health problems affecting intra-Community trade in meat products and amending Directive 64/433/EEC
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposals from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas meat from bovine animals, swine, sheep and goats and domestic solipeds, poultrymeat, game meat and treated products derived from such meat are included in the list of products in Annex II to the Treaty; whereas production of and trade in these products constitute an important source of income for part of the farming population;
Whereas, in order to ensure the rational development of this sector and to increase productivity, public health rules governing production and placing on the market must be laid down at Community level;
Whereas the Community has to adopt measures for the progressive establishment of the internal market over a period expiring on 31 December 1992;
Whereas Directive 77/99/EEC (4) laid down the health requirements to be complied with in intra-Community trade in meat products;
Whereas Directive 89/662/EEC (5) laid down rules on the checks to be applied with a view to the completion of the internal market, and in particular abolished veterinary checks at frontiers between Member States;
Whereas to take account of the abolition of the said checks and of the introduction of more stringent guarantees at origin when it is no longer possible to distinguish between products for the domestic market and products to be marketed in another Member State, the requirements of Directive 77/99/EEC should be adapted and extended to all production;
Whereas the object of this adaptation must be in particular to standardize health requirements for the production, storage and transport of meat products and other products of animal origin intended for human consumption;
Whereas a system of approval should be introduced for the establishments which meet the health requirements laid down by this Directive, together with a Community inspection procedure to ensure that the conditions for such approval are observed;
Whereas low-capacity establishments should be approved by means of simplified structure and infrastructure criteria, while complying with the rules of hygiene laid down in this Directive;
Whereas health marking of meat products is the best way of satisfying the competent authority of the place of destination that a consignment complies with the provisions of this Directive; whereas the health certificate should be maintained for the purposes of verifying the destination of certain products;
Whereas the rules, principles and safeguard measures established by Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (6) should apply here;
Whereas, in the context of intra-Community trade, the rules laid down in Directive 89/662/EEC should also be applied;
Whereas the Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas, to that end, procedures should be laid down establishing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee;
Whereas in view of the particular supply difficulties arising from its geographical situation special derogations should be permitted for the Hellenic Republic; whereas for the same reasons remote regions should be given additional time to comply with the requirements of this Directive;
Whereas the adoption of specific rules for the products covered by this Directive is without prejudice to the adoption of rules on food hygiene and safety in general, on which the Commission has submitted a proposal for a framework Directive;
Whereas for the sake of clarity Directive 77/99/EEC should be updated and Directive 64/433/EEC (7) on health problems affecting intra-Community trade in fresh meat should be adapted,
Article 1
As from 1 January 1993 the title, Articles 1 to 21 and the Annexes to Directive 77/99/EEC shall be replaced by the text annexed to this Directive.
Article 2
Directive 91/497/EEC is hereby amended as follows:
1. In the title, the words 'amending and consolidating` shall be replaced by 'amending and updating` and the words 'and amending Directive 72/462/EEC` shall be added.
2. Article 1 shall be replaced by the following:
'Article 1
As from 1 January 1993 the title and Articles of Directive 64/433/EEC shall be replaced in accordance with the Annex to this Directive.`
3. In the Annex, in the title of Directive 64/433/EEC, the reference to '26 June 1964` shall be deleted.
4. In Chapter XII of Annex I to Directive 64/433/EEC, in the third paragraph of point 60, the following sentence shall be added:
'This requirement may be waived for frozen meat intended to be used without further processing as a raw material for the products referred to in Directive 77/99/EEC or Directive 88/657/EEC.`
Article 3
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1993, except in the case of:
- remote regions recognized in accordance with Article 17 of Directive 90/675/EEC, including - as regards the Kingdom of Spain - the Canary Islands, and with Article 13 of Directive 91/496/EEC,
and
- establishments situated in the new Laender of the Federal Republic of Germany covered by restructuring plans,
in respect of which they shall comply with this Directive not later than 1 January 1995.
They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19922037",
"UKSI19923298",
"UKSI19912825",
"UKSI19921971",
"UKSI19902490",
"UKSI19943082"
] |
31992L0008 | 1992 | Fourteenth Commission Directive 92/8/EEC of 18 February 1992 adapting to technical progress Annexes III, IV, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 91/184/EEC (2), and in particular Article 8 (2) thereof,
Whereas, on the basis of the available information, the substances, colouring agents, preservatives, and ultraviolet filters whose date of admission expired on 31 December 1991 should continue to be used in cosmetic products for a further six months;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the removal of technical barriers to trade in the cosmetic products sector,
Article 1
Directive 76/768/EEC is hereby amended as follows:
1. In Annex III, Part 2, the date of 31 December 1991 in the 'allowed until' column is replaced by that of 30 June 1992 for the following substance:
2.1,1,1-Trichloroethane (methyl chloroform);
2. In Annex IV, Part 2, the date of 31 December 1991 in the 'allowed until' column is replaced by that of 30 June 1992 for the following numbers and denominations: 26 100, 73 900, 74 189, Solvent Yellow 98 and 15 585;
3. In Annex VI, Part 2, the date of 31 December 1991 in the 'allowed until' column is replaced by that of 30 June 1992 for the following substances:
2. Chlorphenesin (INN)
15. Benzethonium chloride (INN) (+)
16. Benzalkonium chloride (INN), bromide and saccharinate (+)
20. Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate) (+)
21. Benzylhemiformal (a 1: 1 mixture of benzyloxymethanol and (benzyloxymethoxy) methanol)
26. Glutaraldehyde
27. 3-Decyloxy 2-hydroxy-1-amino propane-hydro-chloride (Decominol) (INN);
4. In Annex VII, Part 2, the date of 31 December 1991 in the 'allowed until' is replaced by that of 30 June 1992 for the following substances:
1. N-Propoxylated ethyl-4-aminobenzoate (mixed isomers)
2. Ethoxylated ethyl-4-aminobenzoate
4. Glycerol 1-(4-aminobenzoate)
5. 2-Ethylhexyl 4-dimethylaminobenzoate
6. 2-Ethylhexyl salicylate
12. Isopentyl-4-methoxycinnamate (mixed isomers)
13. 2-Ethylhexyl 4-methoxycinnamate
16. 2-Hydroxy-4-methoxy-4-methylbenzophenone (mexenone)
17. 2-Hydroxy-4-methoxybenzophenone-5 sulphonic acid and sodium salt (Sulisobenzone and Sulisobenzone sodium)
24. Alpha-(2-Oxoborn-3-ylidene) toluene-4-sulphonic acid and its salts
25. 3(4-Methylbenzylidene)-d-1-camphor
26. 3-Benzylidene camphor
28. 4-Isopropyl-dibenzoylmethane
29. 4-Isopropylbenzyl salicylate
31. 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)
propane-1-3-dione
32. 2,4,6-Trianilino-(p-carbo-2-ethylhexyl-1-oxi)-
1,3,5-triazine.
Article 2
1. Regardless of the dates of admission mentioned in Article 1, Member States shall take all the necessary measures to ensure that as from 1 July 1992, for the substances referred to in Article 1, neither manufacturers nor importers established in the Community shall place on the market products which do not comply with the requirements of this Directive.
2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances referred to in Article 1 cannot be sold or otherwise disposed of to the final consumer after 30 June 1993 if they do not comply with the requirements of this Directive.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1992. They shall forthwith inform the Commission thereof.
When the Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19921525"
] |
31992L0009 | 1992 | Commission Directive 92/9/EEC of 19 February 1992 amending certain Annexes to Council Directive 69/208/EEC on the marketing of seed of oil and fibre plants
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (1), as last amended by Council Directive 90/654/EEC (2), and in particular Article 20a thereof,
Whereas, in the light of the development of scientific and technical knowledge, Annexes I and II to Directive 69/208/EEC should be amended in respect of organisms harmful to soya bean for the reasons set out below;
Whereas, according to present scientific and technical knowledge, Pseudomonas syringae pv. glycinea, Diaporthe phaseolorum var. caulivora and var. sojae, Phialophora gregata and Phytophthora megasperma f.sp. glycinea have been considered as harmful organisms whose introduction could be prohibited in certain Member States under the Community plant health regime established under Directive 77/93/EEC (3), as amended;
Whereas the relevant Annexes to Directive 77/93/EEC are now being amended to take into account the actual spread situation of the organisms concerned;
Whereas, nevertheless, it is desirable to ensure that the abovementioned harmful organisms which may reduce the usefulness of seed should be kept at the lowest possible level;
Whereas in the cases of Pseudomonas syringae pv. glycinea and Diaporthe phaseolorum var. caulivora and var. sojae it is desirable that appropriate standards applicable to soya bean seed should be laid down in order to maintain the usefulness of the seed despite a certain level of contamination by the said harmful organisms;
Whereas the inert matter in seed lots represents a risk for the spread of Phialophora gregata and Phytophthora megasperma f.sp. glycinae; whereas appropriate standards in respect of the maximum content of inert matter in soya bean seed should be adopted in order to reduce the risk of contamination by the said harmful organisms;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,
Article 1
Directive 69/208/EEC is hereby amended as follows:
1. The following sentence is added to paragraph 4 of Annex I:
'In the case of Glycine max., this condition is applicable in particular to the organisms Pseudomonas syringae pv. glycinea, Diaporthe phaseolorum var. caulivora and var. sojae, Phialophora gregata and Phytophthora megasperma f.sp. glycinea.'
2. The following sub-paragraph is added to Section I (3) of Annex II:
'C. Particular standards or other conditions applicable to Glycine max:
(a) In respect of Pseudomonas syringae pv. glycinea, the maximum number of sub-samples within a sample of 5 000 seeds minimum per lot subdivided into 5 sub-samples which have been found to be contaminated by the said organism shall not exceed 4.
Where suspect colonies are identified in all five subsamples, appropriate biochemical tests on the suspect colonies isolated on a preferential medium for each subsample may be used to confirm the above standards or conditions.
(b) In respect of Diaporthe phaseolorum the maximum number of seeds contaminated shall not exceed 15 %.
(c) The percentage by weight of inert matter, as defined in accordance with current international testing methods, shall not exceed 0,3 %.
In accordance with the procedure laid down in Article 20, Member States may be authorized not to carry out the examination in respect of the above particular standards or other conditions unless, on the basis of previous experience, there is doubt whether those standards or conditions have been satisfied.'
Article 2
The standards and conditions referred to in Article 1 above shall, where appropriate, be reviewed by 30 June 1995 at the latest.
Article 3
Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive by 30 June 1992 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 4
This Directive is addressed to the Member States. | [
"UKSI19921613"
] |
31992L0013 | 1992 | Council Directive 92/13/EEC of 25 February 1992 coordinating the laws, regulations and administrative provisions relating to the application of Community rules on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission(1) ,
In cooperation with the European Parliament(2) ,
Having regard to the opinion of the Economic and Social Committee(3) ,
Whereas Council Directive 90/531/EEC of 17 September 1990 on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors(4) lays down rules for procurement procedures to ensure that potential suppliers and contractors have a fair opportunity to secure the award of contracts, but does not contain any specific provisions ensuring its effective application;
Whereas the existing arrangements at both national and Community levels for ensuring its application are not always adequate;
Whereas the absence of effective remedies or the inadequacy of existing remedies could deter Community undertakings from submitting tenders; whereas, therefore, the Member States must remedy this situation;
Whereas Council Directive 89/665/EEC of 21 December 1989 on the coordination of the laws, regulations and administrative provisions relating to the application of review procedures to the award of public supply and public works contracts(5) is limited to contract award procedures within the scope of Council Directive 71/305/EEC of 26 July 1971 concerning the coordination of procedures for the award of public works contracts(6) , as last amended by Directive 90/531/EEC, and Council Directive 77/62/EEC of 21 December 1976 coordinating procedures for the award of public supply contracts(7) , as last amended by Directive 90/531/EEC;
Whereas the opening-up of procurement in the sectors concerned to Community competition implies that provisions must be adopted to ensure that appropriate review procedures are made available to suppliers or contractors in the event of infringement of the relevant Community law or national rules implementing that law;
Whereas it is necessary to provide for a substantial increase in the guarantees of transparency and non-discrimination and whereas, for it to have tangible effects, effective and rapid remedies must be available;
Whereas account must be taken of the specific nature of certain legal orders by authorizing the Member States to choose between the introduction of different powers for the review bodies which have equivalent effects;
Whereas one of these options includes the power to intervene directly in the contracting entities' procurement procedures such as by suspending them, or by setting aside decisions or discriminatory clauses in documents or publications;
Whereas the other option provides for the power to exert effective indirect pressure on the contracting entities in order to make them correct any infringements or prevent them from committing infringements, and to prevent injury from occurring;
Whereas claims for damages must always be possible;
Whereas, where a claim is made for damages representing the costs of preparing a bid or of participating in an award procedure, the person making the claim is not be required, in order to obtain the reimbursement of his costs, to prove that the contract would have been awarded to him in the absence of such infringement;
Whereas the contracting entities which comply with the procurement rules may make this known through appropriate means; whereas this requires an examination, by independent persons, of procurement procedures and practices applied by those entities;
Whereas for this purpose an attestation system, allowing for a declaration on the correct application of the procurement rules, to be made in notices published in the Official Journal of the European Communities, is appropriate;
Whereas the contracting entities should have the opportunity of having recourse to the attestation system if they so wish; whereas the Member States must offer them the possibility of doing so; whereas they can do so either by setting up the system themselves or by allowing the contracting entities to have recourse to the attestation system established by another Member State; whereas they may confer the task of carrying out the examination under the attestation system to persons, professions or staff of institutions;
Whereas the necessary flexibility in the introduction of such a system is guaranteed by laying down the essential requirements for it in this Directive; whereas operational details should be provided in European Standards to which this Directive refers;
Whereas the Member States may need to determine operational details prior to, or in addition to, the rules contained in European Standards;
Whereas, when undertakings do not seek review, certain infringements may not be corrected unless a specific mechanism is put in place;
Whereas, accordingly, the Commission, when it considers that a clear and manifest infringement has been committed during a contract award procedure, should be able to bring it to the attention of the competent authorities of the Member State and of the contracting entity concerned so that appropriate steps are taken for the rapid correction of that infringement;
Whereas it is necessary to provide for the possibility of conciliation at Community level to enable disputes to be settled amicably;
Whereas the application in practice of this Directive should be reviewed at the same time as that of Directive 90/531/EEC on the basis of information to be supplied by the Member States concerning the functioning of the national review procedures;
Whereas this Directive must be brought into effect at the same time as Directive 90/531/EEC;
Whereas it is appropriate that the Kingdom of Spain, the Hellenic Republic and the Portuguese Republic are granted adequate additional periods to transpose this Directive, taking account of the dates of application of Directive 90/531/EEC in those countries,
CHAPTER I Remedies at national level
Article 1
1. The Member States shall take the measures necessary to ensure that decisions taken by contracting entities may be reviewed effectively and, in particular, as rapidly as possible in accordance with the conditions set out in the following Articles and, in particular, Article 2 (8), on the grounds that such decisions have infringed Community law in the field or procurement or national rules implementing that law as regards:
(a) contract award procedures falling within the scope of Council Directive 90/531/EEC; and
(b) compliance with Article 3 (2) (a) of that Directive in the case of the contracting entities to which that provision applies.
2. Member States shall ensure that there is no discrimination between undertakings likely to make a claim for injury in the context of a procedure for the award of a contract as a result of the distinction made by this Directive between national rules implementing Community law and other national rules.
3. The Member States shall ensure that the review procedures are available, under detailed rules which the Member States may establish, at least to any person having or having had an interest in obtaining a particular contract and who has been or risks being harmed by an alleged infringement. In particular, the Member States may require that the person seeking the review must have previously notified the contracting entity of the alleged infringement and of his intention to seek review.
Article 2
1. The Member States shall ensure that the measures taken concerning the review procedures specified in Article 1 include provision for the powers:
either
(a) to take, at the earliest opportunity and by way of interlocutory procedure, interim measures with the aim of correcting the alleged infringement or preventing further injury to the interests concerned, including measures to suspend or to ensure the suspension of the procedure for the award of a contract or the implementation of any decision taken by the contracting entity; and
(b) to set aside or ensure the setting aside of decisions taken unlawfully, including the removal of discriminatory technical, economic or financial specifications in the notice of contract, the periodic indicative notice, the notice on the existence of a system of qualification, the invitation to tender, the contract documents or in any other document relating to the contract award procedure in question;
or
(c) to take, at the earliest opportunity, if possible by way of interlocutory procedures and if necessary by a final procedure on the substance, measures other than those provided for in points (a) and (b) with the aim of correcting any identified infringement and preventing injury to the interests concerned; in particular, making an order for the payment of a particular sum, in cases where the infringement has not been corrected or prevented.
Member States may take this choice either for all contracting entities or for categories of entities defined on the basis of objective criteria, in any event preserving the effectiveness of the measures laid down in order to prevent injury being caused to the interests concerned;
(d) and, in both the above cases, to award damages to persons injured by the infringement.
Where damages are claimed on the grounds that a decision has been taken unlawfully, Member States may, where their system of internal law so requires and provides bodies having the necessary powers for that purpose, provide that the contested decision must first be set aside or declared illegal.
2. The powers referred to in paragraph 1 may be conferred on separate bodies responsible for different aspects of the review procedure.
3. Review procedures need not in themselves have an automatic suspensive effect on the contract award procedures to which they relate.
4. The Member States may provide that, when considering whether to order interim measures, the body responsible may take into account the probable consequences of the measures for all interests likely to be harmed, as well as the public interest, and may decide not to grant such measures where their negative consequences could exceed their benefits. A decision no to grant interim measures shall not prejudice any other claim of the person seeking these measures.
5. The sum to be paid in accordance with paragraph 1 (c) must be set at a level high enough to dissuade the contracting entity from committing or persisting in an infringement. The payment of that sum may be made to depend upon a final decision that the infringement has in fact taken place.
6. The effects of the exercise of the powers referred to in paragraph 1 on a contract concluded subsequent to its award shall be determined by national law. Furthermore, except where a decision must be set aside prior to the award of damages, a Member State may provide that, after the conclusion of a contract following its award, the powers of the body responsible for the review procedures shall be limited to awarding damages to any person harmed by an infringement.
7. Where a claim is made for damages representing the costs of preparing a bid or of participating in an award procedure, the person making the claim shall be required only to prove an infringement of Community law in the field of procurement or national rules implementing that law and that he would have had a real chance of winning the contract and that, as a consequence of that infringement, that chance was adversely affected.
8. The Member States shall ensure that decisions taken by bodies responsible for review procedures can be effectively enforced.
9. Whereas bodies responsible for review procedures are not judicial in character, written reasons for their decisions shall always be given. Furthermore, in such a case, provision must be made to guarantee procedures whereby any allegedly illegal measures taken by the review body or any alleged defect in the exercise of the powers conferred on it can be the subject of judicial review or review by another body which is a court or tribunal within the meaning of Article 177 of the Treaty and independent of both the contracting entity and the review body.
The members of the independent body referred to in the first paragraph shall be appointed and leave office under the same conditions as members of the judiciary as regards the authority responsible for their appointment, their period of office, and their removal. At least the President of this independent body shall have the same legal and professional qualifications as members of the judiciary. The independent body shall take its decisions following a procedure in which both sides are heard, and these decisions shall, by means determined by each Member State, be legally binding.
CHAPTER 2 Attestation
Article 3
The Member States shall give contracting entities the possibility of having recourse to an attestation system in accordance with Articles 4 to 7.
Article 4
Contracting entities may have their contract award procedures and practices which fall within the scope of Directive 90/531/EEC examined periodically with a view to obtaining an attestation that, at that time, those procedures and practices are in conformity with Community law concerning the award of contracts and the national rules implementing the law.
Article 5
1. Attestors shall report to the contracting entity, in writing, on the results of their examination. They shall satisfy themselves, before delivering to the contracting entity the attestation referred to in Article 4, that any irregularities identified in the contracting entity's award procedures and practices have been corrected and measures have been taken to ensure that those irregularities are not repeated.
2. Contracting entities having obtained that attestation may include the following statement in notice published in the Official Journal of the European Communities pursuant to Articles 16 to 18 of Directive 90/531/EEC:
'The contracting entity has obtained an attestation in accordance with Council Directive 92/13/EEC that, on ................., its contract award procedures and practices were in conformity with Community law and the national rules implementing that law.'
Article 6
1. Attestors shall be independent of the contracting entities and must be completely objective in carrying out their duties. They shall offer appropriate guarantees of relevant professional qualifications and experience.
2. Member States may identify any persons, professions or institutions whose staff, called upon the act as attestors, they regard as fulfilling the requirements of paragraph 1. For these purposes, Member States may require professional qualifications, at least at the level of a higher education diploma within the meaning of Directive 89/48/EEC(8) , which they regard as relevant, or provide that particular examinations of professional competence organized or recognized by the State offer such guarantees.
Article 7
The provisions of Articles 4, 5 and 6 shall be considered as essential requirements for the development of European standards on attestation.
CHAPTER 3 Corrective mechanism
Article 8
1. The Commission may invoke the procedures for which this Article provides when, prior to a contract being concluded, it considers that a clear and manifest infringement of Community provisions in the field of procurement has been committed during a contract award procedure fallig within the scope of Directive 90/531/EEC or in relation to Article 3 (2) (a) of that Directive in the case of the contracting entities to which that provision applies.
2. The Commission shall notify the Member States and the contracting entity concerned of the reasons which have led it to conclude that a clear and manifest infringement has been committed and request its correction by appropriate means.
3. Within 30 days of receipt of the notification referred to in paragraph 2, the Member States concerned shall communicate to the Commission:
(a) its confirmation that the infringement has been corrected; or
(b) a reasoned submission as to why no correction has been made; or
(c) a notice to the effect that the contract award procedure has been suspended either by the contracting entity on its own initiative or on the basis of the powers specified in Article 2 (1) (a).
4. A reasoned submission in accordance with paragraph 3 (b) may rely among other matters on the fact that the alleged infringement is already the subject of judicial review proceedings or of a review as referred to in Article 2 (9). In such a case, the Member State shall inform the Commission of the result of those proceedings as soon as it becomes known.
5. Where notice has been given that a contract award procedure has been suspended in accordance with paragraph 3 (c), the Member State concerned shall notify the Commission when the suspension is lifted or another contract procedure relating in whole or in part to the same subject matter is begun. That new notification shall confirm that the alleged infringement has been corrected or include an reasoned submission as to why no correction has been made.
CHAPTER 4 Conciliation
Article 9
1. Any person having or having had an interest in obtaining a particular contract falling within the scope of Directive 90/531/EEC and who, in relation to the procedure for the award of that contract, considers that he has been or risks being harmed by an alleged infringement of Community law in the field of procurement or national rules impelementing that law may request the application of the conciliation procedure provided for in Articles 10 and 11.
2. The request referred to in paragraph 1 shall be addressed in writing to the Commission or to the national authorities listed in the Annex. These authorities shall forward requests to the Commission as quickly as possible.
Article 10
1. Where the Commission considers, on the basis of the request referred to in Article 9, that the dispute concerns the correct application of Community law, it shall ask the contracting entity to state whether it is willing to take part in the conciliation procedure. If the contracting entity declines to take part, the Commission shall inform the person who made the request that the procedure cannot be initiated. If the contracting entity agrees, paragraphs 2 to 7 shall apply.
2. The Commission shall propose, as quickly as possible, a conciliator drawn from a list of independent persons accredited for this purpose. This list shall be drawn up by the Commission, following consultation of the Advisory Committee for Public Contracts or, in the case of contracting entities the activities of which are defined in Article 2 (2) (d) of Directive 90/531/EEC, following consultation of the Advisory Committee on Telecommunications Procurement.
Each party to the conciliation procedure shall declare whether it accepts the conciliator, and shall designate an additional conciliator. The conciliators may invite not more than two other persons as experts to advices them in their work. The parties to the conciliation procedure and the Commission may reject any expert invited by the conciliators.
3. The conciliators shall give the person requesting the application of the conciliation procedure, the contracting entity and any other candidate or tenderer participating in the relevant contract award procedure the opportunity to make representations on the matter either orally or in writing.
4. The conciliators shall endeavour as quickly as possible to reach an agreement between the parties which is in accordance with Community law.
5. The conciliators shall report to the Commission on their findings and on any result achieved.
6. The person requesting the application of the concilation procedure and the contracting entity shall have the right to terminate the procedure at any time.
7. Unless the parties decide otherwise, the person requesting the application of the conciliation procedure and the contracting entity shall be responsible for their own costs. In addition, they shall each bear half of the costs of the procedure, excluding the costs of intervening parties.
Article 11
1. Where, in relation to a particular contract award procedure, an interested person within the meaning of Article 9, other than the person requesting the conciliation procedure, is pursuing judicial review proceedings or other proceedings for review within the meaning of this Directive, the contracting entity shall inform the conciliators. These shall inform that person that a request has been made to apply the conciliation procedure and shall invite that person to indicate within a given time limit whether he agrees to participate in that procedure. If that person refuses to participate, the conciliators may decide, acting if necessary by a majority, to terminate the conciliation procedure if they consider that the participation of this person is necessary to resolve the dispute. They shall notify their decision to the Committee and give the reasons for it.
2. Action taken pursuant to this Chapter shall be without prejudice to:
(a) any action that the Commission or any Member State might take pursuant ot Articles 169 or 170 of the Treaty or pursuant to Chapter 3 of this Directive;
(b) the rights of the persons requesting the conciliation procedure, of the contracting entity or of any other person.
CHAPTER 5 Final provisions
Article 12
1. Not later than four years after the application of this Directive, the Commission, in consultation with the Advisory Committee for Public Contracts, shall review the manner in which the provisions of this Directive have been implemented and, in particular, the use of the European Standards and, if necessary, make proposals for amendments.
2. Before 1 March each year the Member States shall communicate to the Commission information on the operation of their national review procedures during the preceding calendar year. The nature of the information shall be determined by the Commission in consultation with the Advisory Committee for Public Contracts.
3. In the case of matters relating to contracting entities the activities of which are defined in Article 2 (2) (d) of Directive 90/531/EEC, the Commission shall also consult the Advisory Committee on Telecommunications Procurement.
Article 13
1. Member States shall take, before 1 January 1993, the measures necessary to comply with this Directive. The Kingdom of Spain shall take these measures not later than 30 June 1995. The Hellenic Republic and the Portuguese Republic shall take these measures not later than 30 June 1997. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain an reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall bring into force the measures referred to in paragraph 1 on the same dates as those (laid down in Directive 90/531/EEC).
3. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive.
Article 14
This Directive is addressed to the Member States. | [
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31992L0012 | 1992 | Council Directive 92/12/EEC of 25 February 1992 on the general arrangements for products subject to excise duty and on the holding, movement and monitoring of such products
Having regard to the Treaty establishing the European Economic Community, and in particular Article 99 thereof,
Having regard to the proposal from the Commission(1) ,
Having regard to the opinion of the European Parliament(2) ,
Having regard to the opinion of the Economic and Social Committee(3) ,
Whereas the establishment and functioning of the internal market require the free movement of goods, including those subject ot excise duties;
Whereas provision should be made to define the territory on which this Directive, as well as the Directive on the rates and structures of duty on products subject to excise duties, are to be applied;
Whereas the concept of products subject to excise duty should be defined; whereas only goods which are treated as such in all the Member States may be the subject of Community provisions; whereas such products may be subject to other indirect taxes for specific purposes; whereas the maintenance or introduction of other indirect taxes must not give rise to border-crossing formalities;
Whereas, in order to ensure the establishment and functioning of the internal market, chargeability of excise duties should be identical in all the Member States;
Whereas any delivery, holding with a view to delivery or supply for the purposes of a trader carrying out an economic activity independently or for the purposes of a body governed by public law, taking place in a Member State other than that in which the product is released for consumption gives rise to chargeability of the excise duty in that other Member State;
Whereas in the case of products subject to excise duty acquired by private individuals for their own use and transported by them, the duty must be charged in the country where they were acquired;
Whereas to establish that products subject to excise duty are not held for private but for commercial purposes, Member States must take account of a number of criteria;
Whereas products subject to excise duty purchased by persons who are not approved warehousekeepers or registered or non-registered traders and dispatched or transported directly or indirectly by the vendor or on his behalf must be subject to excise duty in the Member State of destination;
Whereas in order to ensure that the tax debt is eventually collected it should be possible for checks to be carried out in production and storage facilities; whereas a system of warehouses, subject to authorization by the competent authorities, should make it possible to carry out such checks;
Whereas movement from the territory of one Member State to that of another may not give rise to checks liable to impede free movement within the Community; whereas for the purposes of chargeability it is nevertheless necessary to know of the movements of products subject to excise duty; whereas provision should therefore be made for an accompanying document for such products;
Whereas the requirements to be complied with by authorized warehousekeepers and traders without authorized warehousekeeper status should be laid down;
Whereas provision should be made, to ensure the collection of taxes at the rates laid down by Member States, for the establishment of a procedure for the movement of such goods unter duty suspension;
Whereas in that respect provision should first be made for each consignment to be easily identified; whereas provision should be made for the tax status of the consignment to be immediately identifiable; whereas it is therefore necessary to provide for an accompanying document capable of meeting these needs, which may be either an administrative or commercial document; whereas the commercial document used must contain the essential elements which appear on the administrative document;
Whereas the procedure by which the tax authorities of the Member States are informed by traders of deliveries dispatched or received by means of an accompanying document should be explained;
Whereas there is no need for the accompanying document to be used when the products subject to excise duties are moved under a Community customs procedure other than release for free circulation or are placed in a free zone or a free warehouse;
Whereas in the context of national provisions, excise duty should, in the event of an offence or irregularity, be collected in principle by the Member State on whose territory the offence or irregularity has been committed, or by the Member State where the offence or irregularity was ascertained, or, in the event of non-presentation in the Member State of destination, by the Member State of departure;
Whereas the Member States may provide that products released for consumption should carry fiscal or national identification marks and whereas the use of these marks should not place any obstacle in the way of intra-Community trade;
Whereas payment of the excise duties in the Member State where the products were released for consumption must give rise to the reimbursement of those duties when the products are not intended for consumption in that Member State;
Whereas, as a result of the abolition of the principle of taxes on imports in relations between Member States, the provisions on exemptions and allowances on imports cease to apply in respect of relations between Member States; whereas these provisions should therefore be abolished and the directives concerned adapted accordingly;
Whereas a Committee on Excise Duties should be set up to examine the Community measures necessary for the implementation of the provisions on excise duties;
Whereas Article 1 (2) of the Regulation concerning the elimination of controls and formalities applicable to the cabin and hold baggage of persons taking an intra-Community flight or making an intra-Community sea-crossing states that its enforcement is without prejudice to controls relating to bans or restrictions laid down by Member States, provided that they are compatible with the three Treaties establishing the European Community; whereas in that context the verifications necessary for the enforcement of the quantitative restrictions referred to in Article 26 must be considered to be such controls and, as such, to be compatible with Community legislation;
Whereas a certain period of time will be required to take the necessary measures to alleviate both the social repercussions in the sectors concerned and regional difficulties, particularly in border regions, which might arise as a result of the abolition of taxes on imports and exemptions on exports in trade between the Member States; whereas to that end the Member States should be authorized, for a period ending on 30 June 1999, to exempt products supplied, within the limits laid down, by tax-free shops in the context of passenger traffic by air or sea between the Member States:
Whereas small wine producers may be exempted from certain requirements under the general arrangements for excise duty;
Whereas, finally, Council Directive 77/799/EEC of 19 December 1977 concerning mutual assistance by the competent authorities of the Member States in the field of direct taxation and value addes tax(4) should be amended in order to extend its provisions to cover excise duties,
TITLE I General Provisions
Article 1
1. This Directive lays down the arrangements for products subject to excise duties and other indirect taxes which are levied directly or indirectly on the consumption of such products, except for value added tax and taxes established by the Community.
2. The particular provisions relating to the structures and rates of duty on products subject to excise duty shall be set out in specific Directives.
Article 2
1. This Directive and the Directives listed in Article 1 (2) shall apply in the territory of the Community as defined, for each Member State, by the Treaty establishing the European Economic Community, and in particular Article 227 thereof, except for the following national territories:
- in the case of the Federal Republic of Germany, the Island of Heligoland and the territory of Buesingen,
- in the case of the Italian Republic, Livigno, Campione d'Italia and the Italian waters of Lake Lugano,
- in the case of the Kingdom of Spain, Ceuta and Melilla.
2. Nothwithstanding paragraph 1, this Directive and the Directives referred to in Article 1 (2) shall not apply to the Canary Islands. However, the Kingdom of Spain may give notice, by means of a declaration, that these Directives apply to those territories in respect of all or some of the products referred to in Article 3 (1) below, as from the first day of the second month following deposit of that declaration.
3. By way of derogation from paragraph 1, neither this Directive nor those referred to in Article 1 (2) shall apply to the overseas departments of the French Republic.
However, the French Republic may give notice, by means of a declaration, that these Directives apply to those territories - subject to measures to adjust to their extreme remoteness - from the first day of the second month following deposit of the declaration.
4. The Member States shall take the necessary measures to ensure that transactions originating in or intended for:
- the Principality of Monaco are treated as transactions originating in or intended for the French Republic,
- Jungholz and Mittelberg (Kleines Walsertal) are treated as transactions originating in or intended for the Federal Republic of Germany,
- the Isle of Man are treated as transactions originating in or intended for the United Kingdom of Great Britain and Northern Ireland,
- San Marino are treated as transactions originating in or intended for the Italian Republic.
5. The provisions of this Directive shall not prevent Greece from maintaining the specific status granted to Mount Athos as guaranteed by Article 105 of the Greek Constitution.
6. If the Commission considers that the exclusions provided for in paragraphs 1, 2, 3 and 4 are no longer justified, particularly in terms of fair competition, it shall submit appropriate proposals to the Council.
Article 3
1. This Directive shall apply at Community level to the following products as defined in the relevant Directives:
- mineral oils,
- alcohol and alcoholic beverages,
- manufactured tobacco.
2. The products listed in paragraph 1 may be subject to other indirect taxes for specific purposes, provided that those taxes comply with the tax rules applicable for excise duty and VAT purposes as far as determination of the tax base, calculation of the tax, chargeability and monitoring of the tax are concerned.
3. Member States shall retain the right to introduce or maintain taxes which are levied on products other than those listed in paragraph 1 provided, however, that those taxes do not give rise to border-crossing formalities in trade between Member States.
Subject to the same proviso, Member States shall also retain the right to levy taxes on the supply of services which cannot be characterized as turnover taxes, including those relating to products subject to excise duty.
Article 4
For the purpose of this Directive, the following definitions shall apply:
(a) authorized warehousekeeper: a natural or legal person authorized by the competent authorities of a Member State to produce, process, hold, receive and dispatch products subject to excise duty in the course of his business, excise duty being suspended unter tax-warehousing arrangement;
(b) tax warehouse: a place where goods subject to excise duty are produced, processed, held, received or dispatched under duty-suspension arrangements by an authorized warehousekeeper in the course of his business, subject to certain conditions laid down by the competent authorities of the Member State where the tax warehouse is located;
(c) suspension arrangement: a tax arrangement applied to the production, processing, holding and movement of products, excise duty being suspended;
(d) registered trader: a natural or legal person without authorized warehousekeeper status, authorized by the competent authorities of a Member State to receive, in the course of his business, products subject to excise duty from another Member State under duty-suspension arrangements. This type of trader may neither hold nor dispatch such products under excise duty-suspension arrangements;
(e) non-registered trader: a natural or legal person without authorized warehousekeeper status, who is entitled, in the course of his business, to receive occasionally products subject to excise duty from another Member State under duty-suspension arrangements. This type of trader may neither hold nor dispatch products under excise duty suspension arrangements. A non-registered trader must guarantee payment of excise duty to the tax authorities of the Member States of destination prior to the dispatch of the goods.
Article 5
1. The products referred to in Article 3 (1) shall be subject to excise duty at the time of their production within the territory of the Community as defined in Article 2 or of their importation into that territory.
'Importation of a product subject to excise duty' shall mean the entry of that product into the territory of the Community, including the entry of such a product from a territory covered by Article 2 (1), (2) and (3) or from the Channel Islands.
However, where the product is placed under a Community customs procedure on entry into the territory of the Community, importation shall be deemed to take place when it leaves the Community customs procedure.
2. Without prejudice to national and Community provisions regarding customs matters, when products subject to excise duty coming from or going to third countries are under a Community customs procedure other than release for free circulation or are placed in a free zone or a free warehouse, the excise duty on them shall be deemed to be suspended.
Article 6
1. Excise duty shall become chargeable at the time of release for consumption or when shortages are recorded which must be subject to excise duty in accordance with Article 14 (3).
Release for consumption of products subject to excise duty shall mean:
(a) any departure, including irregular departure, from a suspension arrangement;
(b) any manufacture, including irregular manufacture, of those products outside a suspension arrangement;
(c) any importation of those products, including irregular importation, where those products have not been placed under a suspension arrangement.
2. The chargeability conditions and rate of excise duty to be adopted shall be those in force on the date on which duty becomes chargeable in the Member State where release for consumption takes place or shortages are recorded. Excise duty shall be levied and collected according to the procedure laid down by each Member State, it being understood that Member States shall apply the same procedures for levying and collection to national products and to those from other Member States.
Article 7
1. In the event of products subject to excise duty and already released for consumption in one Member State being held for commercial purposes in another Member State, the excise duty shall be levied in the Member State in which those products are held.
2. To that end, without prejudice to Article 6, where products already released for consumption as defined in Article 6 in one Member State are delivered, intended for delivery or used in another Member State for the purposes of a trader carrying out an economic activity independently or for the purposes of a body governed by public law, excise duty shall become chargeable in that other Member State.
3. Depending on all the circumstances, the duty shall be due from the person making the delivery or holding the products intended for delivery or from the person receiving the products for use in a Member State other than the one where the products have already been released for consumption, or from the relevant trader or body governed by public law.
4. The products referred to in paragraph 1 shall move between the territories of the various Member States under cover of an accompanying document listing the main data from the document referred to in Article 18 (1). The form and content of this document shall be established in accordance with the procedure laid down in Article 24 of this Directive.
5. The person, trader or body referred to in paragraph 3 must comply with the following requirements:
(a) before the goods are dispatched, make a declaration to the tax authorities of the Member State of destination and guarantee the payment of the excise duty;
(b) pay the excise duty of the Member State of destination in accordance with the procedure laid down by that Member State;
(c) consent to any check enabling the administration of the Member State of destination to satisfy itself that the goods have actually been received and that the excise duty to which they are liable has been paid.
6. The excise duty paid in the first Member State referred to in paragraph 1 shall be reimbursed in accordance with Article 22 (3).
Article 8
As regards products acquired by private individuals for their own use and transported by them, the principle governing the internal market lays down that excise duty shall be charged in the Member State in which they are acquired.
Article 9
1. Without prejudice to Articles 6, 7 and 8, excise duty shall become chargeable where products for consumption in a Member State are held for commercial purpose in another Member State.
In this case, the duty shall be due in the Member State in whose territory the products are and shall become chargeable to the holder of the products.
2. To establish that the products referred to in Article 8 are intended for commercial purposes, Member States must take account, inter alia, of the following:
- the commercial status of the holder of the products and his reasons for holding them,
- the place where the products are located or, if appropriate, the mode of transport used,
- any document relating to the products,
- the nature of the products,
- the quantity of the products.
For the purposes of applying the content of the fifth indent of the first subparagraph, Member States may lay down guide levels, solely as a form of evidence. These guide levels may not be lower than:
(a) Tobacco products
cigarettes 800 items
cigarillos (cigars weighing not more than 3 g each)400 items
cigars 200 items
smoking tobacco 1,0 kg;
(b) Alcoholic beverages
spirit drinks 10 l
intermediate products 20 l
wines (including a maximum of 60 l of sparkling wines) 90 l
beers 110 l.
Until 30 June 1977 Ireland shall be authorized to apply guide levels which may not be less than 45 litres for wine (including a maximum of 30 litres of sparkling wine) and 55 litres for beer.
3. Member States may also provide that excise duty shall become chargeable in the Member State of consumption on the acquisition of mineral oils already released for consumption in antoher Member State if such products are transported using atypical modes of transport by private individuals or on their behalf. Atypical transport shall mean the transport of fuels other than in the tanks of vehicles or in appropriate reserve fuel canisters and the transport of liquid heating products other than by means of tankers used on behalf of professional traders.
Article 10
1. Products subject to excise duty purchased by persons who are not authorized warehousekeepers or registered or non-registered traders and dispatched or transported directly or indirectly by the vendor or on his behalf shall be liable to excise duty in the Member State of destination. For the purposes of this Article, 'Member State of destination' shall mean the Member State of arrival of the dispatch or transport.
2. To that end, the delivery of products subject to excise duty already released for consumption in a Member State and giving rise to the dispatch or transport of those products to a person as referred to in paragraph 1, established in another Member State, and which are dispatched or transported directly or indirectly by the vendor or on his behalf shall cause excise duty to be chargeable on those products in the Member State of destination.
3. The duty of the Member State of destination shall be chargeable to the vendor at the time of delivery. However, Member States may adopt provisions stipulating that the excise duty shall be payable by a tax representative, other than the consignee of the products. Such tax representative must be established in the Member State of destination and approved by the tax authorities of that Member State.
The Member State in which the vendor is established must ensure that he complies with the following requirements:
- guarantee payment of excise duty under the conditions set by the Member State of destination prior to dispatch of the products and ensure that the excise duty is paid following arrival of the products,
- keep accounts of deliveries of products.
4. In the case referred to in paragraph 2, the excise duty paid in the first Member State shall be reimbursed in accordance with Article 22 (4).
5. Subject to Community law, Member States may lay down specific rules for applying this provision to products subject to excise duty which are covered by special national distribution arrangements compatible with the Treaty.
TITLE II Production, processing and holding
Article 11
1. Each Member State shall determine its rules concerning the production, processing and holding of products subject to excise duty, subject to the provisions of this Directive.
2. Production, processing and holding of products subject to excise duty, where the latter has not been paid, shall take place in a tax warehouse.
Article 12
The opening and operation of tax warehouses shall be subject to authorization from the competent authorities of the Member States.
Article 13
An authorized warehousekeeper shall be required to:
(a) provide a guarantee, if necessary, to cover production, processing and holding and a compulsory guarantee to cover movement, the conditions for which shall be set by the tax authorities of the Member States where the tax warehouse is authorized;
(b) comply with the requirements laid down by the Member State within whose territory the tax warehouse is situated;
(c) keep, for each warehouse, accounts of stock and product movements;
(d) produce the products whenever so required;
(e) consent to all monitoring and stock checks.
The requirements must respect the principle of non-discrimination between national and intra-Community transactions.
Article 14
1. Authorized warehousekeepers shall be exempt from duty in respect of losses occuring under suspension arrangements which are attributable to fortuitous events or force majeure and established by the authorized of the Member State concerned. They shall also be exempt, under suspension arrangements, in respect of losses inherent in the nature of the products during production and processing, storage and transport. Each Member State shall lay down the conditions under which these exemptions are granted. These exemptions shall apply equally to the traders referred to in Article 16 during the transport of products under excise duty suspension arrangements.
2. Losses referred to in paragraph 1 occuring during the intra-Community transport of products under excise duty suspension arrangements must be established according to the rules of the Member State of destination.
3. Without prejudice to Article 20, the duty on shortages other than the losses referred to in paragraph 1 and losses for which the exemptions referred to in paragraph 1 are not granted shall be levied on the basis of the rates applicable in the Member States concerned at the time the losses, duly established by the competent authorities, occured, or if necessary at the time the shortage was recorded.
TITLE III Movement of goods
Article 15
1. Without prejudice to the provisions of Articles 5 (2), 16 and 19 (4), the movement of products subject to excise duty under suspension arrangements must take place between tax warehouses.
2. Warehousekeepers authorized by the competent authorities of a Member State in accordance with Article 13 shall be deemed to be authorized for both national and intra-Community movement.
3. The risks inherent in intra-Community movement shall be covered by the guarantee provided by the authorized warehousekeeper of dispatch, as provided for in Article 13, or if need be, by a guarantee jointly and severally binding both the consignor and the transporter. If appropriate, Member States may require the consignee to provide a guarantee.
The detailed rules for the guarantee shall be laid down by the Member States. The guarantee must be valid throughout the Community.
4. Without prejudice to the provision of Article 20, the liability of the authorized warehousekeeper of dispatch and, if the case arises, that of the transporter may only be discharged by proof that the consignee has taken delivery of the products, in particular by the accompanying document referred to in Article 18 under the conditions laid down in Article 19.
Article 16
1. Notwithstanding Article 15 (1), the consignee may be a professional trader without authorized warehousekeeper status. This trader may, in the course of his business, receive products subject to excise duty from other Member States under duty-suspension arrangements. However, he may neither hold nor dispatch such products under excise duty-suspension arrangements.
Subject to Community law, Member States may lay down specific rules for applying this provision to products subject to excise duty that are covered by special national distribution arrangements compatible with the Treaty.
2. The above trader may request, prior to the receipt of goods, to be registered by the tax authorities of his Member State.
A registered trader must comply with the following requirements:
(a) guarantee payment of excise duty under the conditions set by the tax authorities of his Member State, without prejudice to Article 15 (4) laying down the liability of the authorized warehousekeeper of dispatch and, if the case arises, of the transporter;
(b) keep accounts of deliveries of products;
(c) produce the products whenever so required;
(d) consent to all monitoring and stock checks.
For this type of trader excise duty shall be chargeable at the time of receipt of the goods and shall be paid in accordance with the procedure laid down by each Member State.
3. If the trader referred to in paragraph 1 above is not registered with the tax authorities of his Member State, he must comply with the following requirements:
(a) before the goods are dispatched, make a declaration to the tax authorities of the Member States of destination and guarantee the payment of excise duty, without prejudice to Article 15 (4) laying down the liability of the authorized warehousekeeper of dispatch and, if the case arises, of the transporter;
(b) pay the excise duty of the Member State of destination at the time of receipt of the goods in accordance with the procedure laid down by that Member State;
(c) consent to any check enabling the administration of the Member State of destination to satisfy itself that the goods have actually been received and that the excise duty to which they are liable has been paid.
4. Subject to the provisions set out in paragraphs 2 and 3, the provisions of this Directive relating to the movement of products subject to excise duty under duty-suspension arrangements shall apply.
Article 17
A tax representative may be appointed by the authorized warehousekeeper of dispatch. This tax representative must be established in the Member State of destination and authorized by the tax authorities of that State. He must, instead of and in the place of the consignee without authorized warehousekeeper status, comply with the following requirements:
(a) guarantee the payment of excise duty under the conditions set by the tax authorities of the Member State of destination, without prejudice to Article 15 (4) laying down the liability of the authorized warehousekeeper of dispatch and, if the case arises, the transporter;
(b) pay the excise duty of the Member State of destination at the time of receipt of the goods in accordance with the procedure laid down by the Member States of destination;
(c) keep an account of deliveries of products and advise the tax authorities of the Member States of destination of the place where the goods are delivered.
Article 18
1. Notwithstanding the possible use of computerized procedures, all products subject to excise duty moving under duty-suspension arrangements between Member States shall be accompanied by a document drawn up by the consignor. This document may be either an administrative document or a commercial document. The form and content of this document shall be established in accordance with the procedure laid down in Article 24 of this Directive.
2. In order to identify the goods and conduct checks, the packages should be numbered and the products described using the document referred to in paragraph 1. If need be, each container should be sealed by the consignor when the means of transport is recognized as suitable for sealing by the Member States of departure or the packages should be sealed by the consignor.
3. In cases where the consignee is not an authorized warehousekeeper or a registered trader and notwithstanding Article 17, the document referred to in paragraph 1 must be accompanied by a document certifying that excise duty has been paid in the Member State of destination or that any other procedure for collection of duty has been complied with in accordance with the conditions laid down by the competent authorities of the Member State of destination.
This document must give:
- the address of the office concerned of the tax authorities in the Member State of destination,
- the date and reference of payment or of the acceptance of the guarantee of payment by this office.
4. Paragraph 1 shall not apply when products subject to excise duty move under the conditions referred to in Article 5 (2).
5. Without prejudice to Article 3 (1), Member States may maintain their rules on movement and storage of raw materials used in the manufacture or preparation of products subject to excise duty.
Article 19
1. The tax authorities of the Member States shall be informed by traders of deliveries dispatched or received by means of the document or a reference to the document specified in Article 18. This document shall be drawn up in quadruplicate:
- one copy to be kept by the consignor,
- one copy for the consignee,
- one copy to be returned to the consignor for discharge,
- one copy for the competent authorities of the Member State of destination.
The competent authorities of each Member State of dispatch may provide for the use of an additional copy of the document for the competent authorities of the Member State of departure.
The Member States of destination may stipulate that the copy to be returned to the consignor for discharge should be certified or endorsed by its national authorities. Member States applying this provision must inform the Commission which shall in turn inform the other Member States thereof.
The procedure to be followed with respect to the copy for the competent authorities of the Member States of destination shall be adopted in accordance with the procedure provided for in Article 24.
2. When products subject to excise duty move under the duty-suspension arrangements to an authorized warehousekeeper or to a registered or non-registered trader, a copy of the accompanying administrative document or a copy of the commercial document, duly annotated, shall be returned by the consignee to the consignor for discharge, at the latest within 15 days following the month of receipt by the consignee.
The copy to be returned must contain the following details which are required for discharge:
(a) the address of the office of the tax authority for the consignee;
(b) the date and place of receipt of the goods;
(c) a description of the goods received in order to check whether the consignment tallies with the details contained in the document. If it does, the note 'consignment checked' must be added;
(d) the reference or registration number issued, where appropriate, by the competent authorities of the Member State of destination which use such numbering and/or the endorsement of the competent authorities of the Member State of destination if that Member State stipulates that the copy to be returned must be certified or endorsed by its authorities;
(e) the authorized signature of the consignee.
3. The duty-suspension arrangements as defined in Article 4 (c) shall be discharged by the placing of the products subject to excise duty under one of the arrangements referred to in Article 5 (2) and subject to the conditions referred to therein, after the consignor has received the copy to be returned of the accompanying administrative document or a copy of the commercial document, duly annotated, in which it must be noted that the products have been placed under such an arrangement.
4. Where the products subject to excise duty which are moving under the duty-suspension arrangement as defined in Article 4 (c) are exported, this arrangement should be discharged by an attestation drawn up by the customs office of departure from the Community confirming that the product has indeed left the Community. That office must send back to the consignor the certified copy of the accompanying document intended for him.
5. If there is no discharge, the consignor shall inform the tax authorities of his Member State wihtin a time limit to be fixed by those tax authorities. The time limit may not, however, exceed three months from the date of dispatch of the goods.
6. Member States shall cooperate to introduce spot checks which may be conducted, as necessary, by computerized procedures.
Article 20
1. Where an irregularity or offence has been committed in the course of a movement involving the chargeability of excise duty, the excise duty shall be due in the Member State where the offence or irregularity was committed from the natural or legal person who guaranteed payment of the excise duties in accordance with Article 15 (3), without prejudice to the bringing of criminal proceedings.
Where the excise duty is collected in a Member State other than that of departure, the Member State collecting the duty shall inform the competent authorities of the country of departure.
2. When, in the course of movement, an offence or irregularity has been detected without it being possible to determine where it was committed, it shall be deemed to have been committed in the Member State where it was detected.
3. Without prejudice to the provision of Article 6 (2), when products subject to excise duty do not arrive at their destination and it is not possible to determine where the offence of irregularity was committed, that offence or irregularity shall be deemed to have been committed in the Member State of departure, which shall collect the excise duties at the rate in force on the date when the products were dispatched unless within a period of four months of the competent authorities of the correctness of the transaction or of the place where the offence or irregularity was actually committed.
4. If, before the expiry of a period of three years from the date on which the accompanying document was drawn up, the Member State where the offence or irregularity was actually committed is ascertained, that Member States shall collect the excise duty at the rate in force on the date when the goods were dispatched. In this case, as soon as evidence of collection has been provided, the excise duty originally levied shall be refunded.
Article 21
1. Without prejudice to Article 6 (1), Member States may require that products released for consumption in their territory shall carry tax markings or national identification marks used for fiscal purposes.
2. Any Member State which requires the use of tax marking or national identification marks as set out in paragraph 1 shall be required to make them available to authorized warehousekeepers of the other Member States. However, each Member State may require that fiscal marks be made available to a tax representative authorized by the tax authority of that Member State.
Member States shall ensure that the procedure concerning these markings does not create obstacles to the free movement of products subject to excise duty.
3. Tax markings or identification marks within the meaning of paragraph 1 shall be valid in the Member State which issued them.
However, there may be mutual recognition of these markings between Member States.
4. Mineral oils may be held, transported or used in Ireland, other than in the running tanks of vehicles permitted to use rebated fuel, only where they comply with that State's control and marking requirements.
5. Intra-Community movement of products carrying a tax marking or national identification mark of a Member State within the meaning of paragraph 1 and intended for sale in that Member State, which are within the territory of another Member State, shall take place under cover of an accompanying document as provided for in Article 18 (1) and (3), or if the case arises, in accordance with Article 5 (2).
TITLE IV Reimbursement
Article 22
1. In appopriate cases, products subject to excise duty which have been released for consumption may, at the request of a trader in the course of his business, be eligible for reimbursement of excise duty by the tax authorities of the Member State where they were released for consumption when they are not indented for consumption in that Member State.
However, Member States may refuse request for reimbursement where it does not satisfy the correctness criteria they lay down.
2. In the application of paragraph 1, the following provisions shall apply:
(a) before dispatch of the goods, the consignor must make a request for reimbursement from the competent authorities of his Member State and provide proof that the excise duty has been paid. However, the competent authorities may not refuse reimbursement on the sole grounds of non-presentation of the document prepared by the same authorities certifying that the initial payment had been made;
(b) movement of the goods referred to in (a) shall take place under cover of the document specified in Article 18 (1);
(c) the consignor shall submit to the competent authorities of his Member State the returned copy of the document referred to in (b) duly annotated by the consignee which must either be accompanied by a document certifying that the excise duty has been secured in the Member State of consumption or have the following details added:
- the address of the office concerned of the tax authorities in the Member State of destination,
- the date of acceptance of the declaration by this office together with the reference or registration number of that declaration;
(d) products subject to excise duty and released for consumption in a Member State and thus bearing a tax marking or an identification mark of that Member State may be eligible for reimbursement of the excise duty due from the tax authorities of the Member States which issued the tax markings or identification marks, provided that the tax authorities of the Member State which issued them has established that such markings or marks have been destroyed.
3. In the cases referred to in Article 7, the Member State of departure is required to reimburse the excise duty paid only where the excise duty was previously paid in the Member State of destination in accordance with the procedure laid down in Article 7 (5).
However, Member States may refuse this request for reimbursement where it does not satisfy the correctness criteria they lay down.
4. In the cases referred to in Article 8b the Member State of departure must, at the vendor's request, reimburse the excise duty paid where the vendor has followed the procedures laid down in Article 10 (3).
However, Member States may refuse this request for reimbursement where it does not satisfy the correctness criteria they lay down.
Where the vendor is an authorized warehousekeeper, Member States may stipulate that the reimbursement procedure be simplified.
5. The tax authorities of each Member State shall determine the monitoring procedures and methods applying to reimbursement made in their territory. Member States shall ensure that the reimbursement of excise duty does not exceed the sum actually paid.
TITLE V Exemptions
Article 23
1. Products subject to excise duty shall be exempted from payment of excise duty where they are intended:
- for delivery in the context of diplomatic or consular relations,
- for international organizations recognized as such by the public authorities of the host Member State, and by members of such organizations, within the limits and unter the conditions laid down by the international conventions establishing such organizations or by headquarters agreements,
- for the armed forces of any State party to the North Atlantic Treaty other than the Member State within which the excise duty is chargeable as well as for the armed forces referred to in Article 1 of Decision 90/640/EEC(5) , for the use of those forces, fo the civilian staff accompanying them or for supplying their messes or canteens,
- for consumption under an agreement concluded with non-member countries or international organizations provided that such an agreement is allowed or authorized with regard to exemption from VAT.
These exemptions shall be subject to conditions and limitations laid down by the host Member State until uniform tax rules are adopted. Eligibility for exemption may be grantedin accordance with a procedure for reimbursing excise duties.
2. The Council, acting unanimously on a proposal from the Commission, may authorize any Member State to conclude with a non-member country or an international organization an agreement which may contain exemptions from excise duty.
A State wishing to conclude such an agreement shall bring the matter to the notice of the Commission and provide all the background information necessary. The Commission shall inform the other Member States within one month. The Council's decision shall be deemed to have been adopted if, within two months of other Member States being informed, the matter has not been raised before the Council.
3. The provisions on excise duty laid down in the following Directives shall cease to apply on 31 December 1992:
- Directive 74/651/EEC(6) ,
- Directive 83/183/EEC(7) ,
- Directive 68/297/EEC(8) .
4. The provisions on excise duty laid down in Directive 69/169/EEC(9) shall cease to apply on 31 December 1992 in respect of relations between Member States.
5. Until the Council, acting unanimously on a proposal from the Commission, has adopted Community provisions on stores for boats and aircraft, Member States may maintain their national provisions on the subject.
TITLE VI Committee on excise duties
Article 24
1. The Commission shall be assisted by a Committee on Excise Duties, hereinafter referred to as the 'Committee'. The Committee shall be composed of the representatives of the Member States and chaired by a Commission representative. The Committee shall draw up its rules of procedure.
2. The measures necessary for the application of Articles 7, 18 and 19 shall be adopted in accordance with the procedures laid down in paragraphs 3 and 4.
3. The Commission representative shall submit to the Commission a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The Committee shall take its decision by the majority laid down in Article 148 (2) of the Treaty. The Chairman shall not vote.
4. (a) The Commission shall adopt the intended measures where they are in accordance with the Committee's opinion.
(b) Where the intended measures are not in accordance with the opinion of the Committee, or in the absence of any opinion, the Commission shall forthwith, submit to the Council a proposal relating to the measures to be taken. The Council shall act on a qualified majority.
If, on the expiry of three months from the date on which the matter was referred to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures, save where the Council has decided against the said measures on a simple majority.
5. In addition to the measures referred to in paragraph 2, the Committee shall examine the matters by its chairman, either on his own initiative or at the request of the representative of a Member State, concerning the application of Community provisions on excise duties, except for those referred to in Article 30 of this Directive.
Article 25
The Member States and the Commission shall examine and assess the application of Community provisions on excise duties.
TITLE VII Final provisions
Article 26
1. Without prejudice to Article 8, until 31 December 1996 and subject to a review mechanism similar to that laid down in Article 28 (2) of Directive 77/388/EEC(10) , Denmark shall be authorized to apply the specific arrangements laid down in paragraphs 2 and 3 for spirit drinks and manufactured tobaccos within the general framework of the approximation of excise duty rates.
2. Denmark shall be authorized to apply the following quantitative restrictions:
- private travellers entering Denmark shall benefit from the allowance in force on 31 December 1992 for cigarettes, cigarillos or smoking tobacco and for spirit drinks,
- travellers resident in Denmark and having been outside Denmark for less than the period in force on 31 December 1992 shall benefit from the allowances in force in Denmark on 31 December 1992 for cigarettes and spirit drinks.
3. Denmark may collect excise duties and carry out the necessary checks with respect to spirit drinks, cigarettes, cigarillos and smoking tobacco.
4. The Council, acting unanimously on a proposal from the Commission, shall decide in conjunction with the approximation of excise duty rates and in the light of the risk of distortion of competition, to modify the provisions of this Article or, if appropriate, to limit the duration of those provisions.
Article 27
Before 1 January 1997 the Council, acting unanimously on the basis of a report from the Commission, shall re-examine the provisions of Articles 7, 8, 9 and 10 and, on the basis of a proposal from the Commission after consulting the European Parliament, adopt any necessary amendments.
Article 28
The following provisions shall apply for the period ending on 30 June 1999:
1. Member States may exempt products supplied by tax-free shops which are carried away in the personal luggage of travellers taking an intra-Community flight or sea-crossing to another Member State.
For the purposes of this provision:
(a) 'tax-free shop' shall mean any establishment situated within an airport or port which fulfils the conditions laid down by the competent public authorities, pursuant in particular to paragraph 3 of this Article;
(b) 'traveller to another Member State' shall mean any passenger holding a transport document, for air or sea travel, stating that the immediate destination is an airport or port situated in another Member State;
(c) 'intra-Community flight or sea-crossing' shall mean any transport, by air or sea, commencing within a Member State, where the actual place of arrival is situated within another Member State.
Products supplied on board an aircraft or ship during the intra-Community passenger service shall be treated in the same way as products supplied by tax-free shops.
This exemption shall also apply to products supplied by tax-free shops situated within one of the two access terminals to the Channel Tunnel to passengers holding transport documents which are valid for the journey between those two terminals.
2. The exemption provided for in paragraph 1 shall apply only to products in quantities which do not exceed the limits, by person and by journey, laid down by Community provisions in force in the context of the movement of travellers between third countries and the Community.
3. Member States shall take the measures necessary to ensure that the exemption provided for in this Article are applied correctly and straightforwardly, and to prevent any possible evasion, avoidance or abuse.
Article 29
1. Member States may exempt small wine producers from the requirements of Titles II and III and from the other requirements relating to movement and monitoring. Where these small producers themselves carry out intra-Community transactions, they shall inform their relevant authorities and comply with the requirements laid down by Commission Regulation No 986/89(11) of 10 April 1989 particularly as regards the register of outgoing products and the accompanying document.
'Small wine producers' should be understood to mean persons producing on average less than 1 000 hl of wine per year.
2. The tax authorities of the Member State of destination shall be informed by the consignee of wine deliveries received by means of the document referred to in paragraph 1 or by making a reference to it.
3. Member States shall take the measures necessary on a bilateral basis to introduce spot checks, which may be conducted, as necessary, by computerized procedures.
Article 30
Directive 77/799/EEC is amended as follows:
1. The title shall be replaced by the following:
'Council Directive of 19 December 1977 concerning mutual assistance by the competent authorities of the Member States in the field of direct and indirect taxation'.
2. In Article 1:
(a) Paragraph 1 shall be replaced by the following:
'1. In accordance with this Directive the competent authorities of the Member State shall exchange any information that may enable them to effect a correct assessment of taxes on income and capital and any information relating to the assessment of the following indirect taxes:
- value added tax,
- excise duty on mineral oils,
- excise duty on alcohol and alcoholic beverages,
- excise duty on manufactured tobacco.'
(b) Paragraph 5 shall be replaced by the following in respect of Denmark, Greece, the United Kingdom and Portugal:
'in Denmark:
- Skatteministeren or an authorized representative;
in Greece:
Ypoyrgos Oikonomikon or an authorized representative;
in the United Kingdom:
- The Commissioners of Customs and Excise or an authorized representative for information required concerning value added tax and excise duty,
- The Commissioners of Irland Revenue or an authorized representative for all other information;
in Portugal:
- O Ministro das Finanças or an authorized representative.'
Article 31
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 January 1993.
However, with regard to Article 9 (3) the Kingdom of Denmark is authorized to introduce the laws, regulations and administrative provisions required for complying with this provisions by 1 January 1993 at the latest.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member State.
2. The Member States shall inform the Commission of the main provisions of national law which they adopt to comply with this Directive.
Article 32
This Directive is addressed to the Member States. | [
"UKPGA19920048"
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31992L0011 | 1992 | Council Directive 92/11/EEC of 3 March 1992 amending Directive 89/396/EEC on indications or marks identifying the lot to which a foodstuff belongs
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas it is necessary to take account of the insurmountable technical problems which made it impossible to implement Directive 89/396/EEC (4), as amended by Directive 91/238/EEC (5), by 20 June 1991; whereas it is therefore necessary to postpone the implementation date,
Article 1
The second indent of the first subparagraph of Article 7 of Directive 89/396/EEC is hereby replaced by the following:
'- prohibit trade in products not complying with this Directive with effect from 1 July 1992. However, trade in products placed on the market or labelled before that date and not conforming with this Directive may continue until stocks run out.'
Article 2
This Directive is addressed to the Member States. | [
"UKSI19961502"
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31992L0015 | 1992 | Commission Directive 92/15/EEC of 11 March 1992 amending Council Directive 83/229/EEC on the approximation of the laws of the Member States relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 (2) thereof,
Whereas Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished state, must not transfer their constituents to foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs;
Whereas the written declaration referred to in Article 6 (5) of Directive 89/109/EEC should be provided for in the event of professional use of regenerated cellulose film for materials and articles intended to come into contact with foodstuffs, except those which are, by their nature, clearly intended for this use;
Whereas Article 4 (2) of Council Directive 83/229/EEC (2), as amended by Directive 86/388/EEC (3), enables Member States to decide whether to allow the use of phthalic esters pending scientific research to assess the risk associated with the use of such substances;
Whereas the scientific data available now make it possible to lay down thresholds below which human exposure to these substances does not involve any risk to human health; whereas, therefore, these substances should be authorized throughout the Community;
Whereas the additives authorized for use in the manufacture of coatings intended to cover regenerated cellulose film should also include the additives used in the manufacture of such film;
Whereas, on the basis of information available, the use of certain new substances may be permitted;
Whereas the Scientific Committee for Food, in accordance with Article 3 of Directive 89/109/EEC, has been consulted on the provisions liable to affect public health;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
Article 1
Directive 83/229/EEC is hereby amended as follows:
1. the following Article 3a is added:
'Article 3a
1. At the marketing stages other than the retail stage, materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 6 (5) of Directive 89/109/EEC (*).
2. Paragraph 1 does not apply to materials and articles made of regenerated cellulose film which by their nature are clearly intended to come into contact with foodstuffs.
(*) OJ No L 40, 11. 2. 1989, p. 38.';
2. paragraph 2 of Article 4 is deleted;
3. in the first part of Annex II, the letter B is added in the 'Denominations' column before the subtitles: '1. Softeners' and '2. Other additives';
4. in the first part of Annex II the following indent is inserted in the list 'B.1. Softeners'; 'Denominations' column, after sorbitol: '- tetraethyleneglycol';
5. (a) in the first part of Annex II the following indent is inserted after the first indent of subheading 'Third class - Anchoring agents' of heading 'B.2. Other additives', in the 'Denominations' column:
'- condensation products of melamine-urea-formaldehyde modified with tris (2-hydroxyethyl) amine';
(b) against this item and under the column 'Restrictions' the following is added:
'Free formaldehyde content on side in contact with foodstuffs " 0,5 mg/dm2.
Free melamine content on side in contact with foodstuffs " 0,3 mg/dm2';
6. (a) in the Second Part of Annex II, the letter C is added in the 'Denominations' column, before the subtitles '1. Polymes 2. Resins 3. Plasticizers';
(b) the following substances are delected from the 'Denominations' column, section 'C.3. Plasticizers':
'- butyl-methylcarboxybutyl phthalate [=butylphthalyl butyl glycolate]
- di-isobutyl phthalate
- di-(methylcyclohexyl) phthalate and its isomers [=sextolphthalate]
- methyl-methylcarboxyethyl phthalate [=methylphthalyl ethyl glycolate]';
(c) the following is added in the 'Restrictions' column for the substance '- butylbenzylphthalate':
' " 2 mg/dm2 in the coating on the side in contact with foodstuffs';
(d) the following is added in the 'Restrictions' column section 'C.3. Plasticizers' for the substance '-di-n-butyl phthalate':
' " 3 mg/dm2 in the coating on the side in contact with foodstuffs';
(e) the following is added in the 'Restrictions' column section 'C.3. Plasticizers' for the substance '- dicyclohexyl phthalate':
' " 4 mg/dm2 in the coating on the side in contact with foodstuffs';
(f) the following is inserted in the 'Denominations' and 'Restrictions' columns after Section 'C.3. Plasticizers':
'C.4. Other additives " 6 mg/dm2 in total in the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs. C.4.1. Additives listed in the first part Same restrictions as in the first part (however, the quantities in mg/dm2 refer to the uncoated regerated cellulose film, inclusive of the coating on the side in contact with foodstuffs).';
(g) heading 4 'Specific coating additives', in the 'Denominations' column is replaced by 'C.4.2. Specific coating additives';
(h) against the heading 'C.4.2. Specific coating additives' the text in the column 'Restrictions' is replaced by the following:
'The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm2 (or a lower limit where one is specified) in the coating on the side in contact with foodstuffs';
(i) heading 'D. Solvents' is replaced by 'C.5. Solvents'.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1993. They shall immediately inform the Commission thereof.
Those laws, regulations and administrative provisions shall apply as follows:
Member States shall:
- permit, by 30 June 1993, the trade and use of regenerated cellulose film complying with Directive 83/229/EEC, as amended by this Directive,
- prohibit, as from 1 July 1994, the trade and use of regenerated cellulose film which is intended to come into contact with foodstuffs and which does not conform to Directive 83/229/EEC, as amended by this Directive.
2. When Member States adopt the measures reffered to in paragraph 1, the measures shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19940979"
] |
31992L0018 | 1992 | Commission Directive 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the texting of veterinary medicinal products
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (1), as amended by Council Directive 87/20/EEC (2),
Having regard to Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of laws of the Member States relating to veterinary medicinal products, and laying down additional provisions for immunological veterinary medicinal products (3), and in particular Article 5 thereof,
Whereas following the adoption of Directive 90/677/EEC, it is necessary to amend the Annex to Directive 81/852/EEC in order to lay down special requirements for the testing of immunological veterinary medicinal products;
Whereas it is further necessary to adapt to technical progress the existing requirements laid down in the Annex to Directive 81/852/EEC;
Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector established under Article 2b of Directive 81/852/EEC,
Article 1
The text of the Annex to Directive 81/852/EEC is hereby replaced by the text of the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 April 1993. They shall forthwith inform the Commission thereof.
2. When the Member States adopt these provisions, the provisions shall contain a reference to this Directive or shall be accompanied by such a reference when they are published in official form. The arrangements for this reference shall be decided by Member States.
Article 3
This Directive is addressed to Member States. | [
"UKSI19932398"
] |
31992L0019 | 1992 | Commission Directive 92/19/EEC of 23 March 1992 amending Directive 66/401/EEC on the marketing of fodder plant seed
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), as last amended by Directive 90/654/EEC (2), and in particular Article 2 (1a) thereof,
Whereas in the light of the development of scientific and technical knowledge concerning the hybrids resulting from the crossing of species covered by Directive 66/401/EEC, the hybrids resulting from the crossing of Festuca pratensis Huds. with Lolium multiflorum Lam. should, owing to their increased importance in the Community, be included in the scope of the said Directive;
Whereas in the light of the development of scientific and technical knowledge, Annexes II and III to the said Directive should be amended in order to adapt the conditions to be satisfied by the seed and the lot and sample weights of Festulolium species;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,
Article 1
Directive 66/401/EEC is hereby amended as follows:
1. The following is added to Article 2 (1) (A) (a):
'This definition shall also cover the following hybrid resulting from the crossing of species referred to above.
Festuca pratensis Huds. × Lolium multiflorum Lam. Hybrid resulting from the crossing of tall fescue with Italian ryegrass (including Westerworld ryegrass) (× Festulolium) '.
2. In Article 3 (1), '× Festulolium' is inserted after 'Festuca rubra L.'
3. In Annex I.3 'or x Festulolium' shall appear each time after 'Lolium species'.
4. In Annex II.I.2.A the following is inserted after 'Festuca rubra L.':
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 '× Festulolium 75 (a) 96 1,5 1,0 0,5 0,3 0 0 (j) (k) 5 (n)'
5. In Annex II.II.2.A the following is inserted after 'Festuca rubra L.':
1 2 3 4 5 6 7 8 '× Festulolium 0,3 20 (a) 2 5 5 (j)'
6. In Annex III the following is inserted after 'Festuca rubra L.':
1 2 3 4 '× Festulolium 10 200 60'
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1992. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive is addressed to the Member States. | [
"UKSI19921615",
"UKSI19921614"
] |
31992L0027 | 1992 | Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission(1) ,
In cooperation with the European Parliament(2) ,
Having regard to the opinion of the Economic and Social Committee(3) ,
Whereas measures aimed a progressively establishing the internal market over a period expiring on 31 December 1992 need to be taken; whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
Whereas Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulations or administrative action relating to medicinal products(4) , as last amended by Directive 89/343/EEC(5) , establishes a list of particulars to be given on the immediate packaging and the outer packaging of medicinal products for human use; whereas this list should be supplemented and details given of how labelling is to be presented;
Whereas Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(6) , as last amended by Directive 89/381/EEC(7) , establishes a non-exhaustive list of particulars to be included in package leaflets; whereas this list should be supplemented and details given of how such leaflets are to be presented;
Whereas the provisions on labelling and on package leaflets should be brought together in a single text;
Whereas the provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information;
Whereas the marketing of medicinal products whose labelling and package leaflets comply with this Directive should not be prohibited or impeded on grounds connected with the labelling or package leaflet,
CHAPTER I Scope and definitions
Article 1
1. This Directive deals with the labelling of medicinal products for human use and leaflets inserted in packages of such products, to which Chapters II, III, IV and V of Directive 65/65/EEC apply.
2. For the purposes of this Directive:
- name of the medicinal product means the name given to a medicinal product, which may be either an invented name or a common or scientific name, together with a trade mark or the name of the manufacturer; the invented name shall not be liable to confusion with the common name,
- common name means the international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name,
- strength of the medicinal product means the content of the active ingredient expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form,
- immediate packaging means the container or other form of packaging immediately in contact with the medicinal product,
- outer packaging means the packaging into which is placed the immediate packaging,
- labelling means information on the immediate or outer packaging,
- package leaflet means a leaflet containing information for the user which accompanies the medicinal product,
- manufacturer means the holder of the authorization referred to in Article 16 of Directive 75/319/EEC on behalf of whom the qualified person has performed the specific obligations laid down in Article 22 of that Directive.
CHAPTER II Labelling of medicinal products
Article 2
1. The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
(a) the name of the medicinal product followed by the common name where the product contains only one active ingredient and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be include in the name of the medicinal product;
(b) a statement of the active ingredients expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;
(c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;
(d) a list of those excipients known to have a recognized action or effect and included in the guidelines published pursuant to Article 12. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;
(e) the method and, if necessary, the route of administration;
(f) a special warning that the medicinal product must be stored out of reach of children;
(g) a special warning, if this is necessary for the medicinal product concerned;
(h) the expiry date in clear terms (month/year);
(i) special storage procautions, if any;
(j) special precautions for disposal of unused medicinal products or waste materials derived from such products, if appropriate;
(k) the name and address of the holder of the authorization for placing the medicinal product on the market;
(l) the number of the authorization for placing the medicinal product on the market;
(m) the manufacturer's batch number;
(n) in the case of self-medication, instructions on the use of the medicinal products.
2. The outer packaging may include symbols or pictograms designed to clarify certain information mentioned in paragraph 1 and other information compatible with the summary of the product characteristics which is useful for health education, to the exclusion of any element of a promotional nature.
Article 3
1. The particulars laid down in Article 2 shall appear on immediate packagings other than those referred to in paragraphs 2 and 3.
2. The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Article 2:
- the name of the medicinal product as laid down in Article 2 (a),
- the name of the holder of the authorization for placing the product on the market,
- the expiry date,
- the batch number.
3. The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Article 2 cannot be displayed:
- the name of the medicinal product and, if necessary, the strength and the route of administration,
- the method of administration,
- the expiry date,
- the batch number,
- the contents by weight, by volume or by unit.
Article 4
1. The particulars referred to in Articles 2 and 3 shall be easily legible, clearly comprehensible and indelible.
2. The particulars listed in Article 2 shall appear in the official language or languages of the Member State where the product is placed on the market. This provision shall not prevent these particulars from being indicated in several languages, provided that the same particulars appear in all the languages used.
Article 5
1. Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling where such labelling complies with the requirements of this Chapter.
2. Notwithstanding paragraph 1, Member States may require the use of certain forms of labelling making it possible to indicate:
- the price of the medicinal product,
- the reimbursement conditions of social security organizations,
- the legal status for supply to the patient, in accordance with Directive 92/26/EEC(8) ,
- identification and authenticity.
CHAPTER III User package leaflet
Article 6
The inclusion in the packaging of all medicinal products of a package leaflet for the information of users shall be obligatory unless all the information required by Article 7 is directly conveyed on the outer packaging or on the immediate packaging.
Article 7
1. The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order:
(a) for the identification of the medicinal product:
- the name of the medicinal product, followed by the common name if the product contains only one active ingredient and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (for example, baby, child, adult) must be included in the name of the medicinal product,
- a full statement of the active ingredients and excipients expressed qualitatively and a statement of the active ingredients expressed quantitatively, using their common names, in the case of each presentation of the product,
- the pharmaceutical form and the contents by weight, by volume or by number of doses of the product, in the case of each presentation of the product,
- the pharmaco-therapeutic group, or type of activity in terms easily comprehensible for the patient,
- the name and address of the holder of the authorization for placing the medicinal product on the market and of the manufacturer;
(b) the therapeutic indications;
(c) a list of information which is necessary before taking the medicinal product:
- contra-indications,
- appropriate precautions for use,
- forms of interaction with other medicinal products and other forms of interaction (for example, alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product,
- special warnings.
this list must:
- take into account the particular condition of certain categories of users (e.g. children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions),
- mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery,
- detail those excipients, knowledge of which is important for the safe and effective use of the medicinal product and included in the guidelines published pursuant to Article 12;
(d) the necessary and usual instructions for proper use, in particular:
- the dosage,
- the method and, if necessary, route of administration,
- the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered,
and, as appropriate, depending on the nature of the product:
- the duration of treatment, where it should be limited,
- the action to be taken in the case of an overdose (for example, symptoms, emergency procedures),
- the course of action to take when one or more doses have not been taken,
- indication, if necessary, of the risk of withdrawal effects;
(e) a description of the undesirable effects which can occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly invited to communicate any undesirable effect which is not mentioned in the leaflet to his doctor or to his pharmacist;
(f) a reference to the expiry date indicated on the label, with:
- a warning against using the product after this date,
- where appropriate, special storage precautions,
- if necessary, a warning against certain visible signs of deterioration;
(g) the date on which the package leaflet was last revised.
2. Notwithstanding paragraph 1 (b), the competent authorities may decide that certain therapeutic indications shall not be mentioned in the package leaflet, where the dissemination of such information might have serious disadvantages for the patient.
3. The package leaflet may include symbols or pictograms designed to clarify certain information mentioned in paragraph 1 and other information compatible with the summary of the product characteristics which is useful for health education, to the exclusion of any element of a promotional nature.
Article 8
The package leaflet must be written in clear and understandable terms for the patient and be clearly legible in the official language or languages of the Member State where the medicinal product is placed on the market. This provision does not prevent the package leaflet being printed in several languages, provided that the same information is given in all the languages used.
Article 9
Member States shall not prohibit or impede the marketing or medicinal products within their territory on grounds relating to the package leaflet if the latter complies with the requirements of this Chapter.
CHAPTER IV General and final provisions
Article 10
1. One or more specimens or mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorizing marketing when the authorization for placing the medicinal product on the market is requested.
2. The competent authorities shall refuse the authorization for placing the medicinal product on the market if the labelling or the package leaflet do not comply with the provisions of this Directive or if they are not in accordance with the particulars listed in the summary of product characteristics referred to in Article 4b of Directive 65/65/EEC.
3. All proposed changes to an aspect of the labelling or the package leaflet covered by this Directive and not connected with the summary of characteristics shall be submitted to the authorities competent for authorizing marketing. If the competent authorities have not opposed a proposed change within 90 days following the introduction of the request, the applicant may put the change into effect.
4. The fact that the competent authorities do not refuse an authorization to place the medicinal product on the market pursuant to paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 does not alter the general legal liability of the manufacturer or as appropriate the holder of the authorization to place the medicinal product on the market.
5. The competent authorities may exempt labels and package leaflets for specific medicinal products from the obligation that certain particulars shall appear and that the leaflet must be in the official language or languages of the Member State where the product is placed on the market, when the product is not intended to be delivered to the patient for self-administration.
Article 11
1. Where the provisions of this Directive are not complied with, and a notice served on the person concerned has remained without effect, the competent authorities of the Member States may suspend the authorization to place the medicinal product on the market, until the labelling and the package leaflet of the medicinal product in question have been made to comply with the requirements of this Directive.
2. All decisions taken pursuant to paragraph 1 shall state in detail the reasons on which they are based. They shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force and of the time limit allowed for the exercise of such remedies.
Article 12
1. As necessary, the Commission shall publish guidelines concerning in particular:
- the formulation of certain special warnings for certain categories of medicinal products,
- the particular information needs relating to self-medication,
- the legibility of particulars on the labelling and package leaflet,
- methods for the identification and authentication of medicinal products,
- the list of excipients which must feature on the labelling of medicinal products and the way these excipients must be indicated.
2. These guidelines shall be adopted in the form of a Directive addressed to the Member States, in accordance with the procedure laid down in Article 2c of Directive 75/318/EEC.
Article 13
Articles 13 to 20 of Directive 65/65/EEC and Articles 6 and 7 of Directive 75/319/EEC are hereby repealed.
Article 14
Member States shall take the measures necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
From 1 January 1994, Member States shall refuse an application for authorization to place a medicinal product on the market or for the renewal of an existing authorization, where the labelling and the package leaflet do not comply with the requirements of this Directive.
Article 15
This Directive is addressed to the Member States. | [
"UKSI19923273",
"UKSI19923274"
] |
31992L0021 | 1992 | Council Directive 92/21/EEC of 31 March 1992 on the masses and dimensions of motor vehicles of category M1
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
Whereas the total-harmonization method will be essential in order fully to achieve the single market;
Whereas this method will to be used at the time of the revision of the entire EEC type-approval procedure, taking account of the spirit of the Council resolution of 7 May 1985 concerning a new approach to the question of technical harmonization and standardization;
Whereas the technical requirements which motor vehicles must satisfy pursuant to national laws relate, inter alia, to their masses and dimensions;
Whereas those requirements differ from one Member State to another; whereas it is therefore necessary that all Member States adopt the same requirements, either in addition to or in place of their existing rules in order to allow, in particular, the EEC type-approval procedure which was the subject of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4), as last amended by Directive 87/403/EEC (5), to be applied in respect of each type of vehicle;
Whereas this Directive will be supplemented by Directives relating to the masses and dimensions of all categories of motor vehicles and their trailers;
Whereas it is not necessary to lay down requirements concerning the dynamic stability of combinations of motor vehicles and trailers since the manufacturers of motor vehicles take this aspect into account when stating the maximum technically permissible towable mass,
Article 1
For the purposes of this Directive, 'vehicle' means any motor vehicle in category M1 as defined in Annex I to Directive 70/156/EEC, intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h.
Article 2
No Member State may refuse EEC type-approval or national type-approval of a type of vehicle, or refuse or prohibit the sale, registration, entry into service or use of a vehicle on grounds relating to its masses and dimensions if these satisfy the requirements set out in Annex I.
Article 3
Any amendments necessary to adapt the requirements of the Annexes to this Directive to technical progress shall be adopted by the Commission in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC.
Article 4
1. Member States shall adopt and publish the provisions necessary to comply with this Directive before 1 July 1992 and shall forthwith inform the Commission thereof.
When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
They shall apply these provisions from 1 October 1992.
2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field covered by this Directive.
Article 5
This Directive is addressed to the Member States. | [
"UKSI19922154"
] |