5.4.93 Council Reg. (EEC) No. 793/93 OJ.No. L 84/ 1

I

(Acts whose publication is obligatory)

COUNCIL REGULATION (EEC) No 793/93

of 23 March 1993

on the evaluation and control of the risks of existing substances

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

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 co-operation with the European Parliament (2) ,

Having regard to the opinion of the Economic and Social

Committee(3) ,

Whereas disparities between the laws, regulations and

administrative provisions relating to the risk evaluation of

existing substances which are in effect or in preparation in

the Member States are liable to hinder trade between

Member States and create unequal conditions of

competition;

Whereas measures for the approximation of the provisions

of the Member States which have as their object the

establishment and functioning of the internal market must,

in so far as they concern health, safety, environmental and

consumer protection, take a high level of protection as a

basis;

Whereas, in order to ensure the protection of man,

including workers and consumers, and of the environment,

it is necessary to carry out at Community level a systematic

evaluation of the risks involving existing substances

appearing in the Einecs (European Inventory of Existing

Commercial Substances)(4) ;

Whereas, in the interests of efficiency and economy, it is

necessary to establish a Community policy which will

ensure a sharing and co-ordination of responsibilities

between Member States, the Commission and

industrialists;

____________

(1) OJ No C 276, 5. 11. 1990, p. 1.

(2) OJ No C 280, 28. 10. 1991, p. 65 and

OJ No C 337, 21. 12. 192.

(3) OJ No C 102, 18. 4. 1991, p. 42.

(4) OJ No C 146, 15. 6. 1990, p. 1.

Whereas a Regulation is the appropriate legal instrument as

it imposes directly on manufacturers and importers precise

requirements to be implemented at the same time and in the

same manner throughout the Community;

Whereas, in order to undertake a preliminary risk

evaluation of existing substances and to identify priority

substances requiring immediate attention, it is necessary to

collect certain information and test data on existing

substances;

Whereas the requirement to provide such information

should not apply to certain substances which, on the basis

of their intrinsic properties, involve only risks generally

recognised as minimal;

Whereas the information should be submitted by

manufacturers and importers to the Commission, which will

send copies to all Member States; whereas, however, it

should be possible for a Member State to ask manufacturers

and importers established in its territory to submit the same

information at the same time to its competent authorities;

Whereas, for the purpose of the risk evaluation of certain

existing substances, it is necessary, in certain cases, to

require manufacturers or importers to submit further data or

to carry out further testing on given existing substances;

Whereas it is necessary to draw up, at Community level,

lists of priority substances which require special attention;

whereas the Commission should submit not later than one

year after the entry into force of this Regulation an initial

priority list;

Whereas the risk evaluation of substances on the priority

lists should be carried out by the Member States; whereas

the latter should be designated at Community level on the

basis of a distribution of responsibilities taking account of

the situation of the Member States; whereas risk evaluation

principles should also be established at Community level;
5.4.93 Council Reg. (EEC) No. 793/93 OJ.No. L 84/ 2

Whereas, in the priority-setting process and risk evaluation

of existing substances, it is necessary to take into account,

in particular, the lack of data on the effects of the

substance, the work already carried out in other

international organisations, such as the Organisation for

Economic Co-operation and Development, and other

legislation and/or Community programmes concerning

dangerous substances;

Whereas it is necessary to adopt at Community level the

results of the risk evaluation and the recommended strategy

for limiting risks in respect of substances on the priority

lists;

Whereas it is appropriate to reduce to a minimum the

number of animals used for experimental purposes in

accordance with the provisions of 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 (5) ; whereas,

wherever possible and in consultation, in particular, with

the European Centre for Alternative Testing Methods, the

use of animals must be avoided by recourse to validated

alternative procedures;

Whereas for tests on chemical substances to be carried out

in the context of this Regulation it is necessary to follow

the good laboratory practices set out in Council Directive

87/18/EEC of 18 December 1986 on the harmonization of

laws, regulations and administrative provisions relating to

the application of the principles of good laboratory practice

and the verification of their application for tests on

chemical substances (6) ;

Whereas the Commission, assisted by a committee made up

of representatives of the Member States, should be given

the necessary powers to adapt certain Annexes to technical

progress and to adopt certain implementing measures in

respect of the Regulation;

Whereas the confidential nature of certain information

covered by industrial or commercial secrecy should be

guaranteed,

HAS ADOPTED THIS REGULATION:

Article 1

Aims and scope

1. This Regulation shall apply to:

(a) the collection, circulation and accessibility of

information on existing substances;

____________

(5) OJ No L 358, 18. 12. 1986, p. 1.

(6) OJ No L 15, 17. 1. 1987, p. 29.

(b) the evaluation of the risks of existing substances to

man, including workers and consumers, and to the

environment, in order to ensure better management of

those risks within the framework of Community

provisions.

2. The provisions of this Regulation shall apply without

prejudice to Community legislation on the protection of

workers and consumers.

Article 2

Definitions

For the purpose of this Regulation:

(a) substances means chemical elements and their

compounds in the natural state or obtained by any

production process, including any additive necessary to

preserve the stability of the product and any impurity

deriving from the process used, but excluding any

solvent which may be separated without affecting the

stability of the substance or changing its composition;

(b) preparations means mixtures or solutions composed of

two or more substances;

(c) importing means bringing into the customs territory of

the Community;

(d) producing means the production of substances which

are isolated in a solid, liquid or gaseous form;

(e) existing substances means substances listed in Einecs.

PART 1

SYSTEMATIC DATA REPORTING AND ESTABLISHMENT

OF LISTS OF PRIORITY SUBSTANCES

Article 3

Data reporting on high volume production or import of

existing substances

Without prejudice to Article 6 (1), any manufacturer who

has produced or any importer who has imported an existing

substance, as such or in a preparation, in quantities

exceeding 1 000 tonnes per year, at least once in the three

years preceding the adoption of this Regulation and/or the

year following its adoption, must submit to the

Commission, in accordance with the procedure laid down

in Article 6 (2) and (3), the following information, as

specified in Annex III, within 12 months of entry into force

of this Regulation in the case of a substance appearing in

Annex I and within 24months in the case of a substance

appearing in Einecs but not in Annex I:

(a) the name and the Einecs number of the substance;

(b) the quantity of the substance produced or imported;
5.4.93 Council Reg. (EEC) No. 793/93 OJ.No. L 84/ 3

(c) the classification of the substance according to Annex I

to Council Directive 67/548/EEC of 27 June 1967 on

the approximation of the laws, regulations and

administrative provisions of the Member States relating

to the classification, packaging and labelling of

dangerous substances (7) or the provisional

classification according to the said Directive, including

the class of danger, the danger symbol, the risk phrases

and the safety phrases;

(d) information on the reasonably foreseeable uses of the

substance;

(e) data on the physico-chemical properties of the

substance;

(f) data on pathways and environmental fate;

(g) data on the ecotoxicity of the substance;

(h) data on the acute and subacute toxicity of the

substance;

(i) data on carcinogenicity, mutagenicity and/or toxicity

for reproduction of the substance;

(j) any other indication relevant to the risk evaluation of

the substance.

Manufacturers and importers must make all reasonable

efforts to obtain existing data regarding points (e) to (j).

However, in the absence of information, manufacturers and

importers are not bound to carry out further tests on animals

in order to submit such data.

Article 4

Data reporting on lower volume production or import

of existing substances

1. Without prejudice to Article 6 (1), any manufacturer

who has produced, or any importer who has imported, an

existing substance, as such or in a preparation, in quantities

exceeding 10 tonnes per year but no greater than 1 000

tonnes per year, at least once in the three years preceding

the adoption of this Regulation and/or the year following its

adoption, shall submit to the Commission, in accordance

with the procedure laid down in Article 6 (2) and (3), the

following information, as specified in Annex IV, within a

period of 24 months, to start once the Regulation has been

in force for three years:

(a) the name of the substance and the Einecs number;

(b) the quantity of the substance produced or imported;

____________

(7) OJ 196, 16. 8. 1967, p. 1. Directive as last amended by

Commission Directive 91/632/EEC (OJ No L 338, 10. 12.

1991, p. 23).

(c) the classification of the substance according to Annex

I to Directive 67/548/EEC or the provisional

classification according to the said Directive,

including the class of danger, the danger symbol, the

risk phrases and the safety phrases;

(d) information on the reasonably foreseeable uses of the

substance.

2. The Commission, in consultation with the Member

States, shall determine the cases in which it is necessary to

request the manufacturers and importers of the substances

declared in pursuance of paragraph 1 to submit additional

information, in the framework of Annex III, on the

physico-chemical properties, toxicity, and ecotoxicity of

such substances, exposure and any other aspect relevant to

the risk evaluation of the substances. However, without

prejudice to Article 12 (2), manufacturers and importers

are not bound to carry out further tests on animals for that

purpose.

The specific information to be submitted and the procedure

to be followed for this submission shall be determined in

accordance with the procedure laid down in Article 15

.Article 5

Exemptions

The substances listed in Annex II shall be exempt from the

provisions of Articles 3 and 4. However, information on the

substances listed in Annex II may be requested by a

procedure laid down in accordance with the procedure

referred to in Article 15.

Article 6

Procedure for data reporting

1. In the case of a substance produced or imported by

several manufacturers or importers, the information

referred to in Article3 and Article 4 (2) may be submitted

by one manufacturer or importer acting, with their

agreement, on behalf of other manufacturers or importers

concerned. The latter shall nevertheless submit to the

Commission the information specified in points 1.1 to1.19

of the data set laid down in Annex III and, in doing so, shall

make reference to the data set submitted by the

manufacturer or importer.

2. In submitting the information referred to in Article 3 and

in Article 4 (1), the manufacturers and importers shall use

only the special software package on diskette made

available free of charge by the Commission.

3. Member States may provide that manufacturers and

importers established in their territory shall be required to

submit simultaneously to their competent authorities the

same information as that forwarded to the Commission

pursuant to Articles 3 and 4.
5.4.93 Council Reg. (EEC) No. 793/93 OJ.No. L 84/ 4

4. On receipt of the data referred to in Articles 3 and 4

respectively, the Commission shall forward copies to all the

Member States.

Article 7

Updating of the reported information and obligation to

submit certain information spontaneously

1. Manufacturers and importers who have submitted

information on a substance in accordance with Articles 3

and 4 shall update the information forwarded to the

Commission.

In particular, they shall submit, where appropriate:

(a) new uses of the substance which substantially change

the type, form, magnitude or duration of exposure of

man or the environment to the substance;

(b) new data obtained on the physico-chemical properties,

toxicological or ecotoxicological effects where this is

likely to be relevant to the evaluation of the potential

risk presented by the substance;

(c) any change in the provisional classification under

Directive 67/548/EEC.They shall also be required to

update the information regarding the production and

import volumes referred to in Articles 3 and 4 every

three years, if there is a change in relation to the

volumes specified in Annex III or Annex IV.

2. Any manufacturer or importer of an existing substance

who acquires knowledge which supports the conclusion

that the substance in question may present a serious risk to

man or the environment shall immediately report such

information to the Commission and to the Member State in

which he is located.

3. Upon receipt of the data referred to in paragraphs 1 and

2, the Commission shall submit copies thereof to all the

Member States.

Article 8

Priority lists

1. On the basis of the information submitted by

manufacturers and importers in accordance with Articles 3

and 4, and on the basis of the national lists of priority

substances, the Commission, in consultation with Member

States, shall regularly draw up lists of priority substances or

groups of substances (hereinafter referred to as priority

lists) requiring immediate attention because of their

potential effects on man or the environment. These lists

shall be adopted in accordance with the procedure laid

down in Article 15 and shall be published by the

Commission for the first time in the course of the year

following the entry into force of the Regulation.

2. The factors to be taken into account in drawing up the

priority lists shall be:

- the effects of the substance on man or the environment,

- the exposure of man or the environment to the

substance,

- the lack of data on the effects of the substance on man

and the environment,

- work already carried out in other international fora,

- other Community legislation and/or programmes

relating to dangerous substances.

A substance subject to evaluation under other Community

legislation should be placed on a priority list only if that

evaluation fails to cover risk to the environment or risk to

man, including workers and consumers, or if those risks

have not been adequately evaluated. An equivalent

evaluation carried out under other Community legislation

should not be repeated under this Regulation. Special

attention shall be given to substances which may have

chronic effects, in particular substances known or suspected

to be carcinogenic, toxic to reproduction and/or mutagenic

or known or suspected to increase the incidence of these

effects.

Article 9

Data to be supplied for substances appearing on the

priority lists

1. For the substances included in the priority lists referred

to in Article 8 (1), manufacturers and importers who have

submitted information on a substance in accordance with

Articles 3 and 4 shall, within six months of publication of

the list, submit to the rapporteur designated in accordance

with Article 10 (1) all relevant available information and

corresponding study reports for risk assessment of the

substance concerned.

2. In addition to the requirement specified in paragraph 1,

and without prejudice to the testing which may be required

under Article 10 (2), if any of the particulars listed in

Annex VII A to Directive 67/548/EEC are not available for

a given priority substance, the manufacturers and importers

who have submitted information on a substance in

accordance with Articles 3 and 4 shall be obliged to carry

out the testing necessary to obtain the missing data and to

provide the test results and test reports to the rapporteur

within 12 months.

3. By way of derogation from paragraph 2, manufacturers

and importers may request of the rapporteur that they
5.4.93 Council Reg. (EEC) No. 793/93 OJ.No. L 84/ 5

be exempted from some or all of the additional testing on

the grounds that a given piece of information is either

unnecessary for risk assessment or is impossible to obtain;

they may also request a longer period where circumstances

so require. Full justification must be provided to support

such derogation and the rapporteur shall decide whether the

request should be accepted. Where derogations are allowed

in conformity with this Article, the rapporteur shall

immediately inform the Commission of his decision. The

Commission shall inform the other Member States. If the

decision of the rapporteur is contested by one of the other

Member States, a final decision shall be taken in

conformity with the committee procedure laid down in

Article 15.

PART 2

RISK EVALUATION

Article 10

Risk evaluation of the substances on the priority lists at

the level of the Member State designated as rapporteur

1. For each substance on the priority lists a Member State

shall be given responsibility for its evaluation in accordance

with the procedure laid down in Article 15, whilst ensuring

fair burden sharing between Member States.

The Member State shall designate a rapporteur for that

substance from among the competent authorities referred to

in Article 13.

The rapporteur shall be responsible for evaluating the

information submitted by the manufacturer(s) or

importer(s) in conformity with the requirements of Articles

3, 4, 7 and 9 and any other available information, and for

identifying, after consultation of the producers or importers

concerned, whether, for the purpose of the risk evaluation,

it is necessary to require the above manufacturers or

importers of priority substances to submit further

information and/or to carry out further testing.

2. Where the rapporteur considers it necessary to request

further information and/or testing, it shall inform the

Commission accordingly. The decision to impose on the

above importers or manufacturers a request for further

information and/or testing and the time limits for

responding to that request shall be taken in accordance with

the procedure laid down in Article 15.

3. The rapporteur for a given priority substance shall

evaluate the risk of that substance to man and the

environment. Where appropriate, it shall suggest a strategy

for limiting these risks, including control measures and/or

surveillance programmes. Where such control measures

include recommendations for restrictions on the marketing

or use of the substance in question, the rapporteur shall

submit an

analysis of the advantages and drawbacks of the substance

and of the availability of replacement substances.

The recommended risk evaluation and strategy shall be

forwarded to the Commission by the rapporteur.

4. The real or potential risk to man and the environment

shall be assessed on the basis of principles adopted, by 4.

June 1994, in accordance with the procedure laid down in

Article 15. These principles shall be regularly reviewed

and, where appropriate, revised in accordance with the

same procedure.

5. When manufacturers or importers are asked for further

information and/or testing, they must also check, in view of

the need to limit practical experiments on vertebrates,

whether the information needed to evaluate the substance is

not available from former manufacturers or importers of the

declared substance and cannot be obtained, possibly against

payment of costs. Where experiments are essential, it must

be checked whether tests on animals cannot be replaced or

limited by using other methods.

Necessary laboratory tests must be performed with due

respect for the principles of ’good laboratory practice’ as

laid down in Directive 87/18/EEC and for the provisions of

Directive 86/609/EEC.

Article 11

Risk evaluation of the substances on the priority lists at

Community level

1. On the basis of the risk evaluation and measures

recommended by the rapporteur, the Commission shall

submit to the Committee referred to in Article 15 (1) a

proposal concerning the results of the risk evaluation of the

priority substances and, if necessary, a recommendation for

an appropriate strategy for limiting those risks.

2. The results of the risk evaluation of the priority

substances, and the recommended strategy shall be adopted

at Community level in accordance with the procedure laid

down in Article 15, and shall be published by the

Commission.

3. On the basis of the risk evaluation and the recommended

strategy referred to in paragraph 2, the Commission shall

decide, where necessary, to propose Community measures

in the framework of 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 (8) or in the

framework of other relevant existing Community

instruments.

____________

(8) OJ No L 262, 27. 9. 1976, p. 201. Directive as last

amended by Directive 91/659/EEC (OJ No L 363, 31. 12.

1991, p. 36).
5.4.93 Council Reg. (EEC) No. 793/93 OJ.No. L 84/ 6

Article 12

Obligations relating to the provision of further

information and to further testing

1. Any manufacturer or importer of a substance appearing

on the priority lists referred to in Article 8 (1) and who has

submitted the information under Articles 3 and 4 must,

within a given time limit, supply the rapporteur with the

data and test results concerning that substance referred

to in Article 9 (1) and (2) and those referred to in

Article 10 (2).

2. Without prejudice to Article 7 (2), where there are valid

reasons for believing that a substance appearing in Einecs

may present a serious risk to man or the environment, a

decision to ask the manufacturer(s) and importer(s) of the

said substance to supply the information which they possess

and/or to subject the existing substance to testing and

provide a report thereon shall be taken in accordance with

the procedure laid down in Article 15.

3. In the case of a substance produced or imported as such

or in a preparation by several manufacturers or importers,

testing in pursuance of paragraphs 1 and 2 may be

performed by one or more manufacturers or importers

acting on behalf of other manufacturers or importers

concerned. The other manufacturers or importers concerned

shall make reference to the tests carried out by that or those

manufacturers or importers and shall make a fair and

equitable contribution to the cost.

Article 13

Collaboration between the Member States and the

Commission

Member States shall designate one or more competent

authorities to participate in the implementation of this

Regulation in collaboration with the Commission, in

particular for the work referred to in Articles 8 and 10. The

Member States shall also designate the authority or

authorities to which the Commission shall send the copy of

the data received.

PART 3

MANAGEMENT, CONFIDENTIALITY, MISCELLANEOUS

AND FINAL PROVISIONS

Article 14

Amendment and adaptation of the Annexes

1. The amendments necessary for adapting Annexes I, II,

III and IV to technical progress shall be adopted in

accordance with the procedure laid down in Article 15.

2. The amendments and adaptations to Annex V shall be

adopted by the Commission.

Article 15

Committee

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 decision 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.

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.

4. (a) Except in the cases referred to in subparagraph (b)

below, if, on the expiry of a period of two months

from the date of referral to the Council, the

Council has not acted, the proposed measures shall

be adopted by the Commission.

(b) In the case of decisions referred to in Article 11

(2) and Article 14 (1) if, on the expiry of a period

of two 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

Confidentiality of data

1. If he considers that there is a confidentiality problem,

the manufacturer or importer may indicate the information

provided for in Articles 3, 4, 7 and 12, which he considers

to be commercially sensitive and disclosure of which might

harm him industrially or commercially, and which he

therefore wishes to be kept secret from all persons other

than Member States and the Commission. Full justification

must be given in such cases.
5.4.93 Council Reg. (EEC) No. 793/93 OJ.No. L 84/ 7

Industrial and commercial secrecy shall not apply to:

- the name of the substance, as given in Einecs,

- the name of the manufacturer or importer,

- data on physico-chemical properties of the substance

and on pathways and environmental fate,

- the summary results of the toxicological and

ecotoxicological tests, in particular data on

carcinogenity, mutagenicity and/or the substance’s

toxicity for reproduction,

- any information relating to the methods and

precautions relating to the substance and the

emergency measures,

- any information which, if withheld, might lead to

animal experiments being carried out or repeated

needlessly,

- analytical methods that make it possible to detect a

dangerous substance when discharged into the

environment as well as to determine the direct

exposure of humans to the substance. If the

manufacturer or importer should himself later disclose

previously confidential information, he shall inform the

competent authority accordingly.

2. The authority receiving the information shall decide on

its own responsibility which information is covered by

industrial and commercial secrecy in accordance with

paragraph 1.

Information accepted as being confidential by the authority

receiving the information shall be treated as being

confidential by the other authorities.

Article 17

Not later than one year following adoption of this

Regulation, Member States shall establish appropriate legal

or administrative measures in order to deal with noncompliance with the provisions of this Regulation.

Article 18

This Regulation shall enter into force on the 60th day

following its publication in the Official Journal of the

European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member

States.

Done at Brussels, 23 March 1993.

For the Council

 The President

 S. AUKEN
5.4.93 Council Reg. (EEC) No. 793/93 OJ.No. L 84/ 8

 ANNEX I

 LIST OF EXISTING SUBSTANCES PRODUCED OR IMPORTED WITHIN THE

 COMMUNITY IN QUANTITIES EXCEEDING 1 000 TONNES PER YEAR (*) (*)

The petroleum products are grouped into 31 groups identified by a number or a number and

a letter (group 1, group 2, group 3A, group 3B, group 3C, group 4A, group 4B, etc.)

For any one particular group of substances, manufacturers or importers may decide to

submit only one set of information, but only in so far as points 2 to 6 inclusive of the

information as laid down in Annex III are concerned; this information will then be taken as

applying to all substances contained within that particular group.
5.4.93 Council Reg. (EEC) No. 793/93 Annex II 1

ANNEX II

LIST OF SUBSTANCES EXEMPT FROM THE PROVISIONS OF ARTICLES 3 AND 4
5.4.93 Council Reg. (EEC) No. 793/93 Annex III and IV 1

ANNEX III

INFORMATION REFERRED TO IN ARTICLE 3

1. General information

1.1. Name of substance

1.2. Einecs No

1.3. CAS No

1.4. Synonyms

1.5. Purity

1.6. Impurities

1.7. Molecular formula

1.8. Structural formula

1.9. Type of substance

1.10. Physical state

1.11. Please indicate who is submitting the data set

1.12. Quantity produced or imported, greater than 1 000 tonnes per year

1.13. Indicate if the substance has been produced during the last 12 months

1.14. Indicate if the substance has been imported during the last 12 months

1.15. Classification and labelling

1.16. Use pattern

1.17. Has the complete data set already been submitted by another manufacturer or importer ?

1.18. Specify if you are acting on behalf of another concerned manufacturer or importer

1.19. Other remarks: (e. g. options for disposal)

2. Physical-chemical data

2.1. Melting point

2.2. Boiling point

2.3. Density

2.4. Vapour pressure

2.5. Partition coefficient (log10 POW)

2.6. Water solubility

2.7. Flash point

2.8. Auto flammability

2.9. Flammability

2.10. Explosive properties

2.11. Oxidizing properties

2.12. Other data and remarks

3. Environmental fate and pathways

3.1. Stability

3.1.1. Photodegradation

3.1.2. Stability in water

3.1.3. Stability in soil

3.2. Monitoring data (environment)

3.3. Transport and distribution between environmental compartments including estimated

environmental concentrations and distribution pathways

3.3.1. Transport

3.3.2. Distribution among environmental compartments

3.4. Biodegradation

3.5. Bioaccumulation

3.6. Other remarks
5.4.93 Council Reg. (EEC) No. 793/93 Annex III and IV 2

4. Ecotoxicity

4.1. Toxicity to fish

4.2. Toxicity to daphnia and other aquatic invertebrates

4.3. Toxicity to algae

4.4. Toxicity to bacteria

4.5. Toxicity to terrestrial organisms

4.6. Toxicity to soil dwelling organisms

4.7. Other remarks

5. Toxicity

5.1. Acute toxicity

5.1.1. Acute oral toxicity

5.1.2. Acute inhalation toxicity

5.1.3. Acute dermal toxicity

5.1.4. Acute toxicity (other routes of administration)

5.2. Corrosiveness and irritation

5.2.1. Skin irritation

5.2.2. Eye irritation

5.3. Sensitization

5.4. Repeated dose toxicity

5.5. Genetic toxicity in vitro

5.6. Genetic toxicity in vivo

5.7. Carcinogenicity

5.8. Toxicity to reproduction

5.9. Other relevant information

5.10. Experience with human exposure

6. List of references

ANNEX IV

INFORMATION REFERRED TO IN ARTICLE 4 (1)

1. General information

1.1. Name of substance

1.2. Einecs No

1.3. CAS No

1.4. Synonyms

1.5. Purity

1.6. Impurities

1.7. Molecular formula

1.8. Structural formula

1.9. Type of substance

1.10. Physical state

1.11. Please indicate who is submitting the data set

1.12. Quantity produced or imported exceeding 10 tonnes per year but not greater than 1 000 tonnes

1.13. Indicate if the substance has been produced during the last 12 months

1.14. Indicate if the substance has been imported during the last 12 months

1.15. Classification and labelling

1.16. Use pattern

1.17. Other remarks
5.4.93 Council Reg. (EEC) No. 793/93 Annex V 1

ANNEX V

COMMUNITY INFORMATION OFFICES

The special software packages are available, on diskette, at the following information offices in the

Community

Germany

Bonn

Kommission der Europaeischen Gemeinschaften

Vertretung in der Bundesrepublik Deutschland

Zitelmannstrasse 22

D-5300 Bonn

Telex 88 66 48 EUROP D

Telefax 5 30 09 50

Berlin

Kommission der Europaeischen Gemeinschaften

Vertretung in der Bundesrepublik Deutschland

Aussenstelle Berlin

Kurfuerstendamm 102

D-1000 Berlin 31

Telex 18 40 15 EUROP D

Telefax 8 92 20 59

Munich

Kommission der Europaeischen Gemeinschaften

Vertretung in der Bundesrepublik Deutschland

Vertretung in Muenchen

Erhardtstrasse 27

D-8000 Muenchen 2

Telex 5 21 81 35

Telefax 2 02 10 15

Belgium

Brussels

(a) Commission des Communautés européennes

Bureau en Belgique

(b) Commissie van de Europese Gemeenschappen

Bureau in België

Rue Archimede 73, B-1040 Bruxelles

Archimedesstraat 73, B-1040 Brussel

Telex 26657 COMTNF B

Telefax 2 35 01 66

Denmark

Copenhagen

Kommissionen for De Europaeiske Faellesskaber

Kontor in Danmark

Hoejbrohus

OEstergade 61

Postbox 144

DK-1004 Koebenhavn K 33

Telex 1 64 02 COMEUR DK

Telefax 33 11 12 03/33 14 12 44
5.4.93 Council Reg. (EEC) No. 793/93 Annex V 2

Spain

Madrid

Comisión de las Comunidades Europeas

Oficina en España

Calle de Serrano 41

5a planta

E-28001 Madrid

Telex 4 68 18 OIPE E

Telefax 2 76 03 87

Barcelona

Edificio Atlantico

Av. Diagonal, 407 bis, Planta 18

08008 Barcelona

Telefax 415 63 11

France

Paris

Commission des Communautés européennes

Bureau de représentation en France

288, Bld. St. Germain

F-75007 Paris

Telex Paris 611019 COMEUR

Telefax 1 45 56 94 19/7

Marseilles

Commission des Communautés européennes

Bureau á Marseille

CMCI

2, rue Henri-Barbusse

F-13241 Marseille Cedex 01

Telex 40 25 38 EURMA

Telefax 91 90 98 07

Greece

Athens

Epitropi ton Evropaikon Koinotiton

Grafeio stin Ellada

2 Vassilissis Sofias

Case postale 1 10 02

GR-Athina 10674

Telex 21 93 24 ECAT GR

Telefax 7 24 46 20

Ireland

Dublin

Commission of the European Communities

Office in Ireland

39 Molesworth Street

IRL-Dublin 2

Telex 9 38 27 EUCO EI

Telefax 71 26 57

Italy

Roma

Commissione delle Comunità europee

Ufficio in Italia

Via Poli 29

I-00187 Roma

Telex 61 01 84 EUROMA I

Telefax 6 79 16 58
5.4.93 Council Reg. (EEC) No. 793/93 Annex V 3

Milan

Commissione delle Comunità europee

Ufficio a Milano

Corso Magenta 59

I-20123 Milano

Telex 31 62 00 EURMIL I

Telefax 4 81 85 43

Luxembourg

Luxembourg

Commission des Communautés européennes

Bureau au Luxembourg

Bâtiment Jean Monnet B/0

Rue Alcide De Gasperi

L-2920 Luxembourg

Telex 34 23/34 46/34 76 COMEUR LU

Telefax 43 01 44 33

Netherlands

The Hague

Commissie van de Europese Gemeenschappen

Bureau in Nederland

Korte Vijverberg 5

NL-2513 AB Den Haag

Telex 3 10 94 EURCO NL

Telefax 364 66 19

Portugal

Lisbon

Comissao das Comunidades Europeias

Gabinete em Portugal

Centro Europeu Jean Monnet

Largo Jean Monnet 1-10o

P-1200 Lisboa

Telex 18810 COMEUR P

Telefax 1 55 43 97

United Kingdom

London

Commission of the European Communities

Office in the United Kingdom

Jean Monnet House

8 Storey's Gate

UK-London SW1P 3AT

Telex 2 32 08 EURUK G

Telefax 7 19 73 19 00/19 20

Belfast

Commission of the European Communities

Office in Northern Ireland

Windsor House

9/15 Bedford Street

UK-Belfast BT2 7EG

Telex 7 41 17 CECBEL G

Telefax 24 82 41
5.4.93 Council Reg. (EEC) No. 793/93 Annex V 4

Cardiff

Commission of the European Communities

Office in Wales

4 Cathedral Road

PO Box 15

UK-Cardiff CF1 9SG

Telex 49 77 27 EUROPA G

Telefax 39 54 89

Edinburgh

Commission of the European Communities

Office in Scotland

7 Alva Street

UK-Edinburgh EH2 4PH

Telex 72 74 20 EUEDING

Telefax 2 26 41 05
Environnement 

 B-Lands Consulting - 136 rue Stalingrad - 38100 Grenoble - France 

 Phone: +33 476 702 688 - Fax: +33 476 702 651 - Email: europa@reach-compliance.eu

 http://www.reach-compliance.eu

REACH COMPLIANCE 

REGULATION (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, 

Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 

1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 

76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.

DIRECTIVE 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC 

on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous 

substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of 

Chemicals (REACH) and establishing a European Chemicals Agency.

About B-Lands Consulting

B-Lands Consulting provides consultancy services and LEAP AHEAD® services designed to help 

worldwide organisations comply with European Union regulations. 

Our company provides business friendly services on the following European Union environmental regulations: 

- REACH (Registration, Evaluation and Authorisation of CHemicals) legislation 

- ELV / VHU (End of Life Vehicle:/ Vehicules Hors d’Usage) legislation 

- EuP (Energy Using Products) legislation 

- WEEE (Waste Electrical and Electronic Equipment) legislation 

- RoHS (Restriction of the use of Hazardous Substances) legislation 

As some EU compulsory requirements are country specific, such as for the WEEE legislation, our services 

are designed to adapt and conform to each country's rules and regulations, while serving both business-tobusiness (B2B) and business-to-consumer (B2C) companies. 

We assist our customers in determining proper regulation compliance schemes, including collaborative 

schemes involving other businesses such as Substance Information Exchange Forums (SIEFs). 

Performed services 

B-Lands Consulting offers one-stop EU regulations compliance solutions throughput all 27-EU Member 

States. 

Services include: 

- EU relevant regulations monitoring. 

- Suppliers chain compliance analysis. 

- Information on products labelling and other manufacturer's obligations. 

- Analysis of the company products distribution system trough all EU states (Subsidiaries, distributors, 

retailers). 

- Audits on manufactured products, chemical substances & preparations (Classifications, exemption 

conditions, etc.). 

- REACH Compliance requirements, risks assessment reports, substances full registration process 

- Design of proposal for cooperation between the client and its EU distributors in any EU member 

state. 

- Conveying products testing through a third party (Testing Labs, certifications) 

- Filling of exemptions petitions on behalf of our clients to the European Commission. 

- A pan European WEEE registration and recycling service for all 27-EU Member States. 

- Handling of all the required paperwork. Contracts, powers of attorney are to be submitted to the 

client for approval and signature. 

Additional benefits are: 

- The implementation and execution of smooth and on schedule compliance overhauls. 

- A single and a consistent corporate solution for all EU compliance requirements. 

- A single entry point for reporting to the EU bodies and registries.