EN Official Journal of the European Communities L 123/1 24.4.98
I
(Acts whose publication is obligatory)
DIRECTIVE 98/8/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 February 1998
concerning the placing of biocidal products on the market
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF
THE EUROPEAN UNION,
Having regard to the Treaty establishing the European
Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social
Committee(2),
Acting in accordance with the procedure laid down in
Article 189b of the Treaty(3) in the light of the joint text
approved on 16 December 1997 by the ConciliationCommittee,
(1)Whereas, in their resolution of 1 February 1993 ona Community programme of policy and action inrelation to the environment and sustainabledevelopment(
4), the Council and the representatives
of the Governments of the Member States, meetingwithin the Council, approved the general approachand strategy of the programme presented by theCommission, in which the need for riskmanagement of non-agricultural pesticides isemphasised;
(2)Whereas, both when the eighth Amendment(5) to
Council Directive 76/769/EEC of 27 July 1976, on
the approximation of the laws, regulations andadministrative provisions of the Member Statesrelating to restrictions on the marketing and use of
(1) OJ C 239, 3.9.1993, p. 3, OJ C 261, 6.10.1995, p. 5 and OJ
C 241, 20.8.1996, p. 8.
(2) OJ C 195, 18.7.1994, p. 70 and OJ C 174, 17.6.1996,
p. 32.
(3) Opinion of the European Parliament of 18 April 1996 (OJ
C 141, 13.5.1996, p. 191), Council common position of20 December 1996 (OJ C 69, 5.3.1997, p. 13) and Decisionof the European Parliament of 13 May 1997 (OJ C 167,2.6.1997, p. 24). Council Decision of 18 December 1997.Decision of the European Parliament of 14 January 1998.
(
4) OJ C 138, 17.5.1993, p. 1.
(5) OJ L 398, 30.12.1989, p. 19.dangerous substances and preparations(6) was
adopted in 1989 and during the discussion in theCouncil on Directive 91/414/EEC concerning theplacing of plant protection products on themarket(
7), the Council expressed concern at the lack
of harmonised Community provisions for biocides,formerly known as non-agricultural pesticides, andinvited the Commission to examine the situation inMember States and the possibility for action atCommunity level;
(3)Whereas biocidal products are necessary for the
control of organisms that are harmful to human or
animal health and for the control of organisms thatcause damage to natural or manufactured products;whereas biocidal products can pose risks to humans,animals and the environment in a variety of waysdue to their intrinsic properties and associated usepatterns;
(4)Whereas the Commission review showed differences
in the regulatory situation in the Member States;
whereas such differences may constitute barriers notonly to trade in biocidal products but also to tradein products treated with them, thereby affecting thefunctioning of the internal market; whereas,therefore, the Commission proposed thedevelopment of a framework of rules relating to theplacing on the market for use of biocidal products,taking as a condition a high level of protection forhumans, animals and the environment; whereas,having regard to the principle of subsidiarity,decisions taken at Community level should berestricted to those necessary for the properfunctioning of the common market and to avoidduplication of work by Member States; whereas adirective on biocidal products is the mostappropriate way of establishing such a framework;
(6) OJ L 262, 27.9.1976, p. 201. Directive as last amended by
Directive 97/16/EC (OJ L 116, 6.5.1997, p. 31).
(7) OJ L 230, 19.8.1991, p. 1. Directive as last amended by
Directive 96/68/EC (OJ L 277, 30.10.1996, p. 25).EN Official Journal of the European Communities L 123/2 24.4.98
(5)Whereas the framework of rules should provide that
biocidal products should not be placed on the
market for use unless they have complied with therelevant procedures of this Directive;
(6)Whereas, to take account of the specific nature of
some biocidal products and the risks associated with
their proposed use, it is appropriate to provide forsimplified authorisation procedures, includingregistration;
(7)Whereas it is appropriate that the applicant submit
dossiers which contain information which is
necessary to evaluate the risks that will arise fromproposed uses of the product; whereas a commoncore data set for active substances and for biocidalproducts in which they are contained is necessaryso as to assist both the applicants seekingauthorisation and those carrying out the evaluationto decide on the authorisation; whereas,furthermore, specific data requirements need to beelaborated for each of the product types covered bythis Directive;
(8)Whereas it is necessary, when biocidal products are
being authorised, to make sure that, when properly
used for the purpose intended, they are sufficientlyeffective and have no unacceptable effect on thetarget organisms such as resistance or unacceptabletolerance, and, in the case of vertebrate animals,unnecessary suffering and pain, and have, in thelight of current scientific and technical knowledge,no unacceptable effect on the environment and, inparticular, on human or animal health;
(9)Whereas it is necessary to provide common
principles for the evaluation and authorisation of
biocidal products to ensure a harmonised approachby Member States;
(10) Whereas Member States should not be prevented
from imposing additional requirements on the use
of biocidal products in so far as these additionalrequirements are in conformity with Communitylaw and in particular do not run counter to theprovisions of this Directive; whereas such provisionsare intended to protect the environment and humanand animal health by means such as epidemiccontrol and food and feedingstuff protection;
(11) Whereas, in the light of the diversity of both the
active substances and the biocidal products
concerned, the data and test requirements shouldsuit the individual circumstances and result in anoverall risk assessment;(12) Whereas it is necessary to establish a Community
list of active substances permitted for inclusion in
biocidal products; whereas a Community proceduremust be laid down for assessing whether or not anactive substance can be entered in the Communitylist; whereas the information that interested partiesmust submit with a view to admission of an activesubstance to the list has to be specified; whereasactive substances on the list should be reviewedperiodically, and, if appropriate, compared witheach other under specific conditions, to takeaccount of developments in science andtechnology;
(13) Whereas, when due account is taken of products
which pose only a low risk, their active substances
should be incorporated in a specific annex; whereassubstances the main use of which is non-pesticidalbut which have some minor use as a biocide eitherdirectly, or in a product consisting of an activesubstance and a simple diluent should beincorporated in a separate specific annex;
(14) Whereas when an active substance is evaluated for
its entry or otherwise in the relevant annexes of the
Directive, it is necessary for such an evaluation tocover, where appropriate, the same aspects as thosecovered by the evaluation made under Directive92/32/EEC of 30 April 1992 amending for theseventh time Directive 67/548/EEC on theapproximation of the laws, regulations andadministrative provisions relating to theclassification, packaging and labelling of dangeroussubstances(
1) and Council Regulation (EEC)
No 793/93 of 23 March 1993 on the evaluation andcontrol of the risks of existing substances(
2) as far
as the risk assessment is concerned; whereas,therefore, the risks associated with the production,use and disposal of the active substance andmaterials treated with it are to be considered in asimilar way as they are in the aforementionedlegislation;
(15) Whereas it is in the interest of the free circulation of
biocidal products, as well as of materials treated
with them, that authorisation granted by oneMember State should be recognised by otherMember States subject to the specific conditionscontained in this Directive;
(16) Whereas, while envisaging harmonised provisions
for all biocidal product types, including those
intended to control vertebrates, the actual use ofsuch types might give rise to concern; whereastherefore Member States should be allowed, subject
(1) OJ L 154, 5.6.1992, p. 1.
(2) OJ L 84, 5.4.1993, p. 1.EN Official Journal of the European Communities L 123/3 24.4.98
to the Treaty, to derogate from the principle of
mutual recognition for biocidal products fallingunder three particular types of biocides wheneverintended to control particular kinds of vertebrates,in so far as such derogations are justified and donot jeopardise the purpose of this Directive;
(17) Whereas it is therefore desirable that a system for
the mutual exchange of information should be
established and that Member States and theCommission should make available to each other onrequest the particulars and scientific documentationsubmitted in connection with applications forauthorisation of biocidal products;
(18) Whereas it should be possible for Member States to
authorise, for a limited period of time, biocidal
products which do not comply with theabovementioned conditions, especially in the eventof an unforeseen danger threatening humans,animals or the environment which cannot becontained by other means; whereas the Communityprocedure should not prevent Member States fromauthorising, for a limited period of time for use intheir territory, biocidal products containing anactive substance not yet entered in the Communitylist, provided that a dossier meeting Communityrequirements has been submitted and the MemberState concerned believes that the active substanceand the biocidal product satisfy the Communityconditions set for them;
(19) Whereas it is essential that this Directive help to
minimise the number of tests on animals and that
testing should be made dependent on the purposeand use of a product;
(20) Whereas close coordination should be ensured with
other Community legislation and in particular with
Directive 91/414/EEC, the Directives concerned withthe protection of water and those concerned withthe contained use and deliberate release ofgenetically modified organisms;
(21) Whereas the Commission is to draw up technical
notes for guidance in particular on the
implementation of the authorisation procedures, theentry of active substances in the appropriateAnnexes, the Annexes relating to data requirementsand the Annex dealing with the commonprinciples;
(22) Whereas, in order to ensure that the requirements
laid down in respect of authorised biocidal productsare satisfied when they are placed on the market,
Member States should make provision forappropriate control and inspection arrangements;
(23) Whereas the implementation of this Directive, the
adaptation of its Annexes to the development of
technical and scientific knowledge and the inclusionof active substances in the appropriate Annexesnecessitate close cooperation between theCommission, the Member States and the applicants;whereas, in cases where the procedure of theStanding Committee on Biocidal Products is to beapplied, this constitutes a suitable basis for suchcooperation;
(24) Whereas an agreement on a modus vivendi between
the European Parliament, the Council and the
Commission concerning the implementing measuresfor acts adopted in accordance with the procedurelaid down in Article 189b of the EC Treaty wasreached on 20 December 1994(
1);
(25) Whereas the Commission will apply the modus
vivendi to the implementing measures flowing from
this Directive that it envisages adopting, includingthose concerning Annexes IA and IB;
(26) Whereas, since the full implementation of this
Directive, and especially the review programme, will
not be achieved for several years, Directive76/769/EEC provides a framework to complementthe development of the positive list by limitations ofthe marketing and use of certain active substancesand products or groups thereof;
(27) Whereas the review programme on active substances
will need to take account of other work
programmes within the framework of otherCommunity legislation concerned with the review orauthorisation of substances and products or relevantinternational Conventions;
(28) Whereas the costs of the procedures associated with
the operation of the Directive need to be recovered
from those seeking to place, or placing, biocidalproducts on the market and from those supportingthe entries of active substances in the relevantAnnexes;
(29) Whereas minimum rules concerning the use of
biocidal products at work are laid down under
Directives on health and safety at work; whereas itis desirable to develop further rules in this area,
(1) OJ C 102, 4.4.1996, p. 1.EN Official Journal of the European Communities L 123/4 24.4.98
HAVE ADOPTED THIS DIRECTIVE:
Article 1
Scope
1. This Directive concerns:
(a) the authorisation and the placing on the market for
use of biocidal products within the Member States;
(b) the mutual recognition of authorisations within the
Community;
(c) the establishment at Community level of a positive
list of active substances which may be used inbiocidal products.
2. This Directive shall apply to biocidal products as
defined in Article 2(1)(a) but shall exclude products thatare defined or within the scope of the followinginstruments for the purposes of these Directives:
(a) Council Directive 65/65/EEC of 26 January 1965 on
the approximation of provisions laid down by law,regulation or administrative action relating toproprietary medicinal products(
1),
(b) Council Directive 81/851/EEC of 28 September 1981
on the approximation of the laws of the MemberStates on veterinary medicinal products(
2),
(c) Council Directive 90/677/EEC of 13 December 1990
extending the scope of Directive 81/851/EEC on theapproximation of the laws of the Member Statesrelating to veterinary medicinal products and layingdown additional provisions for immunologicalmedicinal products(
3),
(d) Council Directive 92/73/EEC of 22 September 1992
widening the scope of Directives 65/65/EEC and75/319/EEC on the approximation of provisions laiddown by law, regulation or administrative actionrelating to medicinal products and laying downadditional provisions on homeopathic medicinalproducts(
4),
(e) Council Directive 92/74/EEC of 22 September 1992
widening the scope of Directive 81/851/EEC on theapproximation of provisions laid down by law,regulation or administrative action relating to
(1) OJ 22, 9.2.1965, p. 369. Directive as last amended by
Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
(2) OJ L 317, 6.11.1981, p. 1. Directive as last amended by
Directive 93/40/EEC (OJ L 214, 24.8.1993, p. 31).
(3) OJ L 373, 31.12.1990, p. 26.
(4) OJ L 297, 13.10.1992, p. 8.veterinary medicinal products and laying down
additional provisions on homeopathic veterinarymedicinal products(
5),
(f) Council Regulation (EEC) No 2309/93 of 22 July
1993 laying down Community procedures for theauthorisation and supervision of medicinal productsfor human and veterinary use and establishing aEuropean Agency for the Evaluation of MedicinalProducts(
6),
(g) Council Directive 90/385/EEC of 20 June 1990 on
the approximation of the laws of the Member Statesrelating to active implantable medical devices(
7),
(h) Council Directive 93/42/EEC of 14 June 1993
concerning medical devices(8),
(i) Council Directive 89/107/EEC of 21 December 1988
on the approximation of the laws of the MemberStates concerning food additives authorised for usein foodstuffs intended for human consumption(
9),
Council Directive 88/388/EEC of 22 June 1988 onthe approximation of the laws of the Member Statesrelating to flavourings for use in foodstuffs and tosource materials for their production(
10) and
European Parliament and Council DirectiveNo 95/2/EC of 20 February 1995 on food additivesother than colours and sweeteners(
11),
(j) Council Directive 89/109/EEC of 21 December 1988
on the approximation of the laws of the MemberStates relating to materials and articles intended tocome into contact with foodstuffs(
12),
(k) Council Directive 92/46/EEC of 16 June 1992 laying
down the health rules for the production and placingon the market of raw milk, heat-treated milk andmilk based products(
13),
(l) Council Directive 89/437/EEC of 20 June 1989 on
hygiene and health problems affecting the productionand the placing on the market of egg products(
14),
(5) OJ L 297, 13.10.1992, p. 12.
(6) OJ L 214, 24.8.1993, p. 1.
(7) OJ L 189, 20.7.1990, p. 17. Directive as last amended by
Directive 93/68/EEC (OJ L 220, 31.8.1993, p. 1).
(8) OJ L 169, 12.7.1993, p. 1.
(9) OJ L 40, 11.2.1989, p. 27. Directive as amended by
Directive 94/34/EC (OJ L 237, 10.9.1994, p. 1).
(10) OJ L 184, 15.7.1988, p. 61. Directive as amended by
Directive 91/71/EEC (OJ L 42, 15.2.1991, p. 25).
(11) OJ L 61, 18.3.1995, p. 1. Directive as amended by Directive
96/85/EC (OJ L 86, 28.3.1997, p. 4).
(12) OJ L 40, 11.2.1989, p. 38.
(13) OJ L 268, 14.9.1992, p. 1. Directive as last amended by
Directive 94/71/EC (OJ L 368, 31.12.1994, p. 33).
(14) OJ L 212, 22.7.1989, p. 87. Directive as last amended by
the 1994 Act of Accession.EN Official Journal of the European Communities L 123/5 24.4.98
(m) Council Directive 91/493/EEC of 22 July 1991 laying
down the health conditions for the production andthe placing on the market of fishery products(
1),
(n) Council Directive 90/167/EEC of 26 March 1990
laying down the conditions governing thepreparation, placing on the market and use ofmedicated feedingstuffs in the Community(
2),
(o) Council Directive 70/524/EEC of 23 November 1970
concerning additives in feedingstuffs(3), Council
Directive 82/471/EEC of 30 June 1982 on certainproducts used in animal nutrition(
4) and Council
Directive 77/101/EEC of 23 November 1976 on themarketing of straight feedingstuffs(
5),
(p) Council Directive 76/768/EEC of 27 July 1976 on
the approximation of the laws of the Member Statesrelating to cosmetic products(
6),
(q) Council Directive 95/5/EC of 27 February 1995
amending Directive 92/120/EEC on the conditionsfor granting temporary and limited derogations fromspecific Community health rules on the productionand marketing of certain products of animalorigin(
7),
(r) Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection productson the market(
8).
3. This Directive shall apply, without prejudice to
relevant Community provisions or measures taken inaccordance with them, in particular, to:
(a) Council Directive 76/769/EEC of 27 July 1976 on
the approximation of the laws, regulations andadministrative provisions of the Member Statesrelating to restrictions on the marketing and use ofcertain dangerous substances and preparations(
9),
(1) OJ L 268, 24.9.1991, p. 15. Directive as last amended by
Directive 95/71/EC (OJ L 332, 30.12.1995, p. 40).
(2) OJ L 92, 7.4.1990, p. 42.
(3) OJ L 270, 14.12.1970, p. 1. Directive as last amended by
Directive 97/6/EC (OJ L 35, 5.2.1997, p. 11).
(4) OJ L 213, 21.7.1982, p. 8. Directive as last amended by
Directive 96/25/EC (OJ L 125, 23.5.1996, p. 35).
(5) OJ L 32, 3.2.1977, p. 1. Directive as last amended by the
1994 Act of Accession.
(6) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Directive 97/18/EC (OJ L 114, 11.5.1997, p. 43).
(7) OJ L 51, 8.3.1995, p. 12.
(8) OJ L 230, 19.8.1991, p. 1. Directive as last amended by
Directive 96/68/EC (OJ L 277, 30.10.1996, p. 25).
(9) OJ L 262, 27.9.1976, p. 201. Directive as last amended by
Directive 97/16/EC (OJ L 116, 6.5.1997, p. 31).(b) Directive 79/117/EEC of 21 December 1978
prohibiting the placing on the market and use ofplant protection products containing certain activesubstances(
10),
(c) Council Regulation (EEC) No 2455/92 of 23 July
1992 concerning the export and import of certaindangerous chemicals(
11),
(d) Council Directive 80/1107/EEC of 27 November
1980, on the protection of workers from the risksrelated to exposure to chemical, physical andbiological agents at work(
12), Council Directive
89/391/EEC of 12 June 1989 on the introduction ofmeasures to encourage improvements in the safetyand health of workers at work(
13) and individual
Directives based on these Directives,
(e) Council Directive 84/450/EEC of 10 September 1984
relating to the approximation of the laws,regulations or administrative provisions of theMember States concerning misleadingadvertising(
14).
4. Article 20 shall not apply to the carriage of biocidal
products by rail, road, inland waterway, sea or air.
Article 2
Definitions
1. For the purposes of this Directive the following
definitions shall apply:
(a)Biocidal products
Active substances and preparations containing one or
more active substances, put up in the form in whichthey are supplied to the user, intended to destroy,deter, render harmless, prevent the action of, orotherwise exert a controlling effect on any harmfulorganism by chemical or biological means.
An exhaustive list of 23 product types with an
indicative set of descriptions within each type isgiven in Annex V.
(10) OJ L 33, 8.2.1979, p. 36. Directive as last amended by the
1994 Act of Accession.
(11) OJ L 251, 29.8.1992, p. 13. Regulation as last amended
by Regulation (EC) No 1492/96 (OJ L 189, 30.7.1996,p. 19).
(
12) OJ L 327, 3.12.1980, p. 8. Directive as last amended by the
1994 Act of Accession.
(13) OJ L 183, 29.6.1989, p. 1.
(14) OJ L 250, 19.9.1984, p. 17.EN Official Journal of the European Communities L 123/6 24.4.98
(b)Low-risk biocidal product
A biocidal product which contains as active
substance(s) only one or more of those listed inAnnex I A and which does not contain anysubstance(s) of concern.
Under the conditions of use, the biocidal product
shall pose only a low risk to humans, animals andthe environment.
(c)Basic substance
A substance which is listed in Annex I B, whose
major use is non-pesticidal but which has someminor use as a biocide either directly or in a productconsisting of the substance and a simple diluentwhich itself is not a substance of concern and whichis not directly marketed for this biocidal use.
The substances, which could potentially enter
Annex IB in accordance with the procedure laiddown in Articles 10 and 11, are inter alia the
following:
— carbon dioxide,— nitrogen,— ethanol,— 2-propanol,— acetic acid,— kieselguhr.
(d)Active substance
A substance or micro-organism including a virus or a
fungus having general or specific action on or againstharmful organisms.
(e)Substance of concern
Any substance, other than the active substance,
which has an inherent capacity to cause an adverseeffect on humans, animals or the environment and ispresent or is produced in a biocidal product insufficient concentration to create such an effect.
Such a substance, unless there are other grounds for
concern, would be normally a substance classifiedas dangerous according to Council Directive67/548/EEC of 27 June 1967 on the approximationof laws, regulations and administrative provisionsrelating to the classification, packaging and labellingof dangerous substances(
1), and present in the
biocidal product at a concentration leading theproduct to be regarded as dangerous within themeaning of Article 3 of Council Directive88/379/EEC of 7 June 1988 on the approximation ofthe laws, regulations and administrative provisions ofthe Member States relating to the classification,packaging and labelling of dangerouspreparations(
2).
(1) OJ 196, 16.8.1967. Directive as last amended by Directive
94/69/EC (OJ L 381, 31.12.1994, p. 1).
(2) OJ L 187, 16.7.1988, p. 14).(f)Harmful organism
Any organism which has an unwanted presence or a
detrimental effect for humans, their activities or theproducts they use or produce, or for animals or forthe environment.
(g)Residues
One or more of the substances present in a biocidal
product which remains as a result of its use includingthe metabolites of such substances and productsresulting from their degradation or reaction.
(h)Placing on the market
Any supply, whether in return for payment or free of
charge, or subsequent storage other than storagefollowed by consignment from the customs territoryof the Community or disposal. Importation of abiocidal product into the customs territory of theCommunity shall be deemed to constitute placing onthe market for the purposes of this Directive.
(i)Authorisation
An administrative act by which the competent
authority of a Member State authorises, following anapplication submitted by an applicant, the placing onthe market of a biocidal product in its territory or ina part thereof.
(j)Frame-formulation
Specifications for a group of biocidal products
having the same use and user type.
This group of products must contain the same active
substances of the same specifications, and theircompositions must present only variations from apreviously authorised biocidal product which do notaffect the level of risk associated with them and theirefficacy.
In this context, a variation is the allowance of a
reduction in the percentage of the active substanceand/or an alteration in percentage composition ofone or more non-active substances and/or thereplacement of one or more pigments, dyes, perfumesby others presenting the same or a lower risk, andwhich do not decrease its efficacy.
(k)Registration
An administrative act by which the competent
authority of a Member State, following anapplication submitted by an applicant, afterverification that the dossier meets the relevantrequirements of this Directive, allows the placing onthe market of a low-risk biocidal product in itsterritory or in a part thereof.
(l)Letter of access
A document, signed by the owner or owners of
relevant data protected under the provisions of thisEN Official Journal of the European Communities L 123/7 24.4.98
Directive, which states that these data may be used
by the competent authority for the purpose ofgranting an authorisation or a registration of abiocidal product under this Directive.
2. For the purposes of this Directive the definitions
for:
(a) substance,(b) preparation,(c) scientific research and development,(d) process-orientated research and developmentlaid down in Article 2 of Council Directive 67/548/EEC
shall apply.
Article 3
Authorisation for placing on the market of biocidal
products
1. Member States shall prescribe that a biocidal
product shall not be placed on the market and used intheir territory unless it has been authorised in accordancewith this Directive.
2. By way of derogation from paragraph 1:
(i) Member States shall, subject to registration, allow
the placing on the market and use of a low-riskbiocidal product, provided that a dossier inaccordance with Article 8(3) has been submitted andverified by the competent authorities.
Unless otherwise specified, all provisions relating to
authorisation under this Directive shall also apply toregistration.
(ii) Member States shall allow the placing on the market
and use of commodity substances for biocidalpurposes once they have been entered in Annex IB.
3. (i) Every application for authorisation shall be
decided on without undue delay.
(ii) For applications for biocidal products that
require registration, the competent authorityshall take a decision within a period of 60days.
4. Member States shall, on request, or may, on
their own initiative, and where relevant, establish aframe-formulation and communicate it to the applicantwhen issuing an authorisation for a particular biocidalproduct.Without prejudice to Articles 8 and 12 and providing
that the applicant has a right of access to theframe-formulation in the form of a letter of access, whena subsequent application for authorisation for a newbiocidal product is based on this frame-formulation, thecompetent authority shall take a decision with regard tothis application within a period of 60 days.
5. Member States shall prescribe that biocidal
products are to be classified, packaged and labelled inaccordance with the provisions of this Directive.
6. Without prejudice to Article 7(1), authorisations
shall be granted for a maximum period of 10 years fromthe date of first or renewed inclusion of the activesubstance in Annex I or I A for the product type, withoutexceeding the deadline specified for the active substancein Annex I or I A; they may be renewed after verificationthat the conditions imposed in Article 5(1) and (2) arestill satisfied. Renewal may, where necessary, be grantedonly for the period necessary to allow the competentauthorities of the Member States to make suchverification, where an application for renewal has beenmade.
7. Member States shall prescribe that biocidal
products are to be properly used. Proper use shall includecompliance with conditions established pursuant toArticle 5 and specified under the labelling provisions ofthis Directive. Proper use shall also involve the rationalapplication of a combination of physical, biological,chemical or other measures as appropriate, whereby theuse of biocidal products is limited to the minimumnecessary. Where biocidal products are used at work, useshall also be in accordance with the requirements ofDirectives for the protection of workers.
Article 4
Mutual recognition of authorisations
1. Without prejudice to Article 12, a biocidal product
that has already been authorised or registered in oneMember State shall be authorised or registered in anotherMember State within 120 days, or 60 days respectively,of an application being received by the other MemberState, provided that the active substance of the biocidalproduct is included in Annex I or I A and conforms tothe requirements thereof. For the mutual recognition ofauthorisations, the application shall include a summaryof the dossier as required in Article 8(2)(a) andAnnex II B, Section X and a certified copy of the firstauthorisation granted. For mutual recognition ofregistration of low-risk biocidal products, the applicationshall include the data requirements of Article 8(3), exceptfor the efficacy data for which a summary shall suffice.EN Official Journal of the European Communities L 123/8 24.4.98
The authorisation may be subject to provisions resulting
from the implementation of other measures in accordancewith Community law, relating to the conditions fordistribution and use of biocidal products intended toprotect the health of the distributors, users and workersconcerned.
This mutual recognition procedure shall be without
prejudice to measures taken by Member States pursuantto Community law intended to protect the health ofworkers.
2. If, in accordance with Article 5, a Member State
establishes that:
(a) the target species is not present in harmful
quantities,
(b) unacceptable tolerance or resistance of the target
organism to the biocidal product is demonstrated,or
(c) the relevant circumstances of use, such as climate or
breeding period of the target species, differsignificantly from those in the Member State wherethe biocidal product was first authorised, and anunchanged authorisation may therefore presentunacceptable risks to humans or the environment,
the Member State may request that certain conditions
referred to in Article 20(3)(e), (f), (h), (j) and (l) beadjusted to the different circumstances, so that conditionsfor issue of an authorisation laid down in Article 5 aresatisfied.
3. Where a Member State believes that a low-risk
biocidal product which has been registered by anotherMember State does not comply with the definitionprovided for in Article 2(1)(b), it may provisionally refuseregistration thereof and shall immediately communicateits concerns to the competent authority responsible forthe verification of the dossier.
If, within a maximum period of 90 days, an agreement is
not reached between the authorities concerned, thematter will be forwarded to the Commission for adecision in accordance with the procedure laid down inparagraph 4.
4. Notwithstanding paragraphs 2 and 3, where a
Member State believes a biocidal product authorised byanother Member State cannot meet the conditions set outpursuant to Article 5(1) and consequently proposes torefuse the authorisation or the registration or to restrictthe authorisation under certain conditions, it shall notifythe Commission, other Member States and the applicantand shall provide them with an explanatory documentcontaining the name of the product and its specificationand setting out the grounds on which it proposes torefuse or to restrict the authorisation.
The Commission shall prepare a proposal on these
matters in accordance with Article 27 for a decisionin accordance with the procedure laid down inArticle 28(2).5. If the procedure laid down in paragraph 4 leads to
the confirmation of a refusal of a second or subsequentregistration by a Member State, the Member State thathad previously registered the low-risk biocidal productshall, where deemed appropriate by the StandingCommittee, take this refusal into consideration andreview its registration according to Article 6.
If this procedure confirms the initial registration, the
Member State having introduced the procedure shallregister the low-risk biocidal product concerned.
6. By way of derogation from paragraph 1, Member
States may refuse, subject to the Treaty, mutualrecognition of authorisations granted for producttypes 15, 17 and 23 of Annex V provided that such alimitation can be justified and does not jeopardise thepurpose of the Directive.
Member States shall inform each other and the
Commission of any decision taken in this respect andindicate the reasons therefor.
Article 5
Conditions for issue of an authorisation
1. Member States shall authorise a biocidal product
only if
(a) the active substance(s) included therein are listed in
Annex I or IA and any requirements laid down inthese Annexes are fulfilled;
(b) it is established, in the light of current scientific and
technical knowledge, and is shown from appraisal ofthe dossier provided for in Article 8, according to thecommon principles for the evaluation of dossiers aslaid down in Annex VI, that, when used asauthorised and having regard to:
— all normal conditions under which the biocidal
product may be used,
— how the material treated with it may be used,— the consequences from use and disposal,
the biocidal product:
(i) is sufficiently effective,
(ii) has no unacceptable effects on the target
organisms, such as unacceptable resistance orcross-resistance or unnecessary suffering andpain for vertebrates,
(iii) has no unacceptable effects itself or as a result
of its residues, on human or animal health,directly or indirectly (e.g. through drinkingEN Official Journal of the European Communities L 123/9 24.4.98
water, food or feed, indoor air or consequences
in the place of work) or on surface water andgroundwater,
(iv) has no unacceptable effect itself, or as a
result of its residues, on the environmenthaving particular regard to the followingconsiderations:
— its fate and distribution in the environment;
particularly contamination of surface waters(including estuarian and seawater),groundwater and drinking water,
— its impact on non-target organisms;
(c) the nature and quantity of its active substances
and, where appropriate, any toxicologically orecotoxicologically significant impurities andco-formulants, and its residues of toxicological orenvironmental significance, which result fromauthorised uses, can be determined according to therelevant requirements in Annex IIA, IIB, IIIA, IIIB,IVA or IVB;
(d) its physical and chemical properties have been
determined and deemed acceptable for purposes ofthe appropriate use, storage and transport of theproduct.
2. A biocidal product classified according to
Article 20(1) as toxic, very toxic or as a category 1 or 2carcinogen, or as a category 1 or 2 mutagen or classifiedas toxic for reproduction category 1 or 2, shall not beauthorised for marketing to, or use by the generalpublic.
3. Authorisation may be conditional on, and must
stipulate the conditions relating to marketing and usenecessary to ensure compliance with the provisions ofparagraph 1.
4. Where other Community provisions impose
requirements relevant to the conditions for the issue of anauthorisation and for use of the biocidal product, andparticularly where these are intended to protect thehealth of distributors, users, workers and consumers oranimal health or the environment, the competentauthority shall take these into account when issuing anauthorisation and where necessary shall issue theauthorisation subject to those requirements.
Article 6
Review of an authorisation
During the period for which an authorisation has been
granted, it may be reviewed at any time, e.g. followinginformation received according to Article 14, if there are
indications that any of the conditions referred to inArticle 5 are no longer satisfied. In such instances theMember States may require the authorisation holder,or the applicant to whom a modification of theauthorisation has been granted in accordance withArticle 7, to submit further information necessary for thereview. If need be, the authorisation may be prolongedonly for the period necessary to complete the review, butshall be prolonged for the period necessary to provide forfurther information.
Article 7
Cancellation or modification of an authorisation
1. An authorisation shall be cancelled if:
(a) the active substance is no longer included in Annex I
or IA as required by Article 5(1)(a);
(b) the conditions within the meaning of Article 5(1) for
obtaining the authorisation are no longer satisfied;
(c) it is discovered that false or misleading particulars
were supplied concerning the facts on the basis ofwhich the authorisation was granted.
2. An authorisation may also be cancelled if the
authorisation holder so requests and states the reasonsfor the cancellation.
3. When a Member State intends to cancel an
authorisation, it shall inform and hear the authorisationholder. When cancelling the authorisation, the MemberState may grant a period of grace for the disposal or forthe storage, marketing and use of existing stocks, of alength in accordance with the reason for the cancellationwithout prejudice to any period provided for by decisiontaken pursuant to Directive 76/769/EEC or in connectionwith paragraph 1(a).
4. Where a Member State considers it necessary, on
the basis of developments in scientific and technicalknowledge and to protect health and the environment, itshall modify the conditions of use of an authorisationand, in particular, the manner of use or the amountsused.
5. An authorisation may also be modified if the
authorisation holder requests it and states the reasons forthe modification.
6. Where a proposed modification concerns an
extension of uses, a Member State shall extend theauthorisation subject to the particular conditions placedon the active substance listed in Annex I or IA.
7. Where a proposed modification of an authorisation
involves changes to the particular conditions placed onEN Official Journal of the European Communities L 123/10 24.4.98
the active substance listed in Annex I or IA, such changes
can be made only after evaluation of the active substance,with regard to the proposed changes, in accordance withthe procedures laid down in Article 11.
8. Modifications shall be granted only if it is
established that the conditions within the meaning ofArticle 5 remain satisfied.
Article 8
Requirements for authorisation
1. Application for authorisation shall be made by, or
on behalf of, the person who will be responsible for thefirst placing on the market of a biocidal product in aparticular Member State and shall be to the competentauthority of that Member State. Every applicant shallbe required to have a permanent office within theCommunity.
2. Member States shall require that an applicant for
authorisation of a biocidal product shall submit to thecompetent authority:
(a) a dossier or a letter of access for the biocidal product
satisfying, in the light of current scientific andtechnical knowledge, the requirements set out inAnnex IIB and, where specified, the relevant parts ofAnnex IIIB, and
(b) for each active substance in the biocidal product, a
dossier or a letter of access satisfying, in the light ofcurrent scientific and technical knowledge, therequirements set out in Annex IIA and, wherespecified, the relevant parts of Annex IIIA.
3. By way of derogating from paragraph 2(a), Member
States shall require a dossier comprising the followingdata for a low-risk biocidal product:
(i) applicant:
1.1. name and address,1.2. manufacturers of the biocidal product and the
active substances,(names and addresses including location ofmanufacturer of the active substance)
1.3. where appropriate, a letter of access to any
relevant data needed,
(ii) identity of the biocidal product:
2.1. trade name,2.2. full composition of the biocidal product,
2.3. physical and chemical properties as referred to
in Article 5(1)(d),(iii) intended uses:
3.1. product type (Annex V) and field of use,3.2. category of users,3.3. method of use,
(iv) efficacy data,
(v) analytical methods,
(vi) classification, packaging and labelling, including a
draft label, according to Article 20,
(vii) safety data sheet prepared in accordance with
Article 10 of Council Directive 88/379/EEC of7 June 1988 on the approximation of the laws,regulations, and administrative provisions of theMember States relating to the classification,packaging and labelling of dangerous substances(
1),
or Article 27 of Directive 67/548/EEC.
4. The dossiers shall include a detailed and full
description of the studies conducted and of the methodsused or a bibliographical reference to those methods. Theinformation in the dossiers supplied in accordance withArticle 8(2) shall be sufficient for an evaluation to bemade of the effects and properties referred to inArticle 5(1)(b), (c) and (d). It shall be submitted to thecompetent authority in the form of technical dossiers,containing the information and results of the studiesreferred to in Annexes IIA and IIB and, where specified,the relevant parts of Annexes IIIA and IIIB.
5. Information which is not necessary owing to the
nature of the biocidal product or of its proposed usesneed not be supplied. The same applies where it is notscientifically necessary or technically possible to supplythe information. In such cases, a justification, acceptableto the competent authority must be submitted. Such ajustification may be the existence of a frame-formulationwhich the applicant has the right to access.
6. If the evaluation of the dossier shows that further
information, including data and results from furthertesting, is necessary to evaluate the risks of the biocidalproduct, the competent authority shall ask the applicantto submit such information. The time period for theevaluation of the dossier shall start only after the dossieris complete.
7. The name of an active substance must be given as
registered in the list contained in Annex I to Directive
(1) OJ L 187, 16.7.1988, p. 14. Directive as amended by
Directive 93/18/EEC (OJ L 104, 29.4.1993, p. 46).EN Official Journal of the European Communities L 123/11 24.4.98
67/548/EEC or, if the name is not included therein, as
given in the European Inventory of Existing ChemicalSubstances (Einecs), or, if the name is not includedtherein, the active substance must be given itsInternational Standards Organisation (ISO) commonname. If the latter is not available, the substance must bedesignated by its chemical designation according toInternational Union of Pure and Applied Chemistry(IUPAC) rules.
8. As a general principle, tests must be conducted
according to the methods described in Annex V toDirective 67/548/EEC. In the event of a method beinginappropriate or not described, other methods usedshould, whenever possible, be internationally recognisedand must be justified. Where appropriate, tests must beconducted in accordance with the provisions laid downin Council Directive 86/609/EEC of 24 November 1986on the approximation of laws, regulations andadministrative provisions of the Member States regardingthe protection of animals used for experimental and otherscientific purposes(
1) and Council Directive 87/18/EEC of
18 December 1986 on the harmonisation of laws,regulations and administrative provisions relating to theapplication of the principles of good laboratory practiceand the verification of their applications for tests onchemical substances(
2).
9. Where test data exist that have been generated
before the adoption of this Directive by methods otherthan those laid down in Annex V to Directive67/548/EEC, the adequacy of such data for the purposesof this Directive and the need to conduct new testsaccording to Annex V must be decided on a case-by-casebasis, taking into account, among other factors, the needto minimise testing on vertebrate animals.
10. Competent authorities as referred to within the
meaning of Article 26 shall ensure that a file is compiledon each application. Each file shall contain at least a copyof the application, a record of the administrativedecisions taken by the Member State concerning theapplication and concerning the dossiers submitted inaccordance with paragraph 2, together with a summaryof the latter. On request, Member States shall makeavailable to the other competent authorities and to theCommission the files provided for in this paragraph; theyshall supply to them, on request, all informationnecessary for full comprehension of applications andshall, where requested, ensure that applicants provide acopy of the technical documentation laid down inparagraph 2.
11. Member States my require that samples of the
preparation and of its ingredients be provided.
12. Member States may require that applications for
authorisation be submitted in their national or officiallanguages or one of these languages.
(1) OJ L 358, 18.12.1986, p. 1.
(2) OJ L 15, 17.1.1987, p. 29.Article 9
Placing on the market of active substances
Member States shall prescribe that where a substance is
an active substance for use in biocidal products it maynot be placed on the market for such use unless:
(a) where the active substance was not on the market
before the date referred to in Article 34(1), a dossierhas been forwarded to a Member State, whichsatisfies the requirements of Article 11(1) and isaccompanied by the declaration that the activesubstance is intended for inclusion in a biocidalproduct. This shall not apply to substances for usepursuant to Article 17;
(b) it is classified, packaged and labelled in accordance
with the provisions of Directive 67/548/EEC.
Article 10
Inclusion of an active substance in Annexes I,
IA or IB
1. In the light of current scientific and technical
knowledge, an active substance shall be included inAnnex I, Annex IA or IB for an initial period notexceeding 10 years if it may be expected that
— biocidal products containing the active substance,— low-risk biocidal products complying with the
definition in Article 2(1)(b),
— commodity substances complying with the definition
in Article 2(1)(c),
will fulfil the conditions laid down in Article 5(1)(b), (c)
and (d), taking into account, where relevant, cumulationeffects from the use of biocidal products containing thesame active substances.
An active substance cannot be included in Annex IA if it
is classified according to Directive 67/548/EEC as:
— carcinogenic,— mutagenic,— toxic for reproduction,— sensitising, or— is bioaccumulative and does not readily degrade.
Where appropriate, the entry of an active substance in
Annex IA shall refer to the concentration ranges betweenwhich the substance can be used.EN Official Journal of the European Communities L 123/12 24.4.98
2. Inclusion of an active substance in Annexes I, IA or
IB shall, where appropriate, be subject to the following:
(i) requirements on:
(a) the minimum degree of purity of the active
substance,
(b) the nature and maximum content of certain
impurities,
(c) product type in which it may be used,
(d) manner and area of use,(e) designation of categories of users (e.g. industrial,
professional or non-professional),
(f) other particular conditions from the evaluation
of the information which has been madeavailable in the context of this Directive;
(ii) the establishment of the following:
(a) acceptable operator exposure level (AOEL), if
necessary,
(b) where relevant, an acceptable daily intake for
man (ADI) and a maximum residue limit(MRL),
(c) fate and behaviour in the environment and
impact on non-target organisms.
3. The inclusion in Annex I, IA or IB of an active
substance shall be restricted to those product types inAnnex V for which relevant data have been submitted inaccordance with Article 8.
4. The inclusion of an active substance in Annex I, IA
or IB may be renewed on one or more occasions forperiods not exceeding 10 years. The initial inclusion, aswell as any renewed inclusion, may be reviewed at anytime if there are indications that any of the requirementsreferred to in paragraph 1 are not longer satisfied.Renewal may, where necessary, be granted only for theminimum period necessary to complete a review, wherean application has been made for such renewal, and shallbe granted for the period necessary to provide furtherinformation requested in accordance with Article 11(2).
5. (i) An entry of an active substance in Annex I and,
where relevant, IA or IB may be refused orremoved,
— if the evaluation of the active substance in
accordance with Article 11(2) shows that,under normal conditions under which it maybe used in authorised biocidal products, risks
to health or the environment still give rise toconcern, and
— if there is another active substance on
Annex I for the same product type which, inthe light of scientific or technical knowledge,presents significantly less risk to health or tothe environment.
When such a refusal or removal is considered, an
assessment of an alternative active substance orsubstances shall take place to demonstrate that itcan be used with similar effect on the targetorganism without significant economic andpractical disadvantages for the user and withoutan increased risk for health or for theenvironment.
The assessment shall be circulated in accordance
with the procedures in Article 11(2) for decisionin accordance with the procedures laid down inArticles 27 and 28(3).
(ii) The refusal or removal of an Annex I and, where
relevant, IA or IB entry shall be carried outunder the following conditions:
1. the chemical diversity of the active substances
should be adequate to minimise occurrence ofresistance in the target organism;
2. it should be applied only to active substances
which, when used under normal conditions inauthorised biocidal products, present asignificantly different level of risk;
3. it should be applied only to active substances
used in products of the same product type;
4. it should be applied only after allowing the
possibility, where necessary, of acquiringexperience from use in practice, if it is notalready available;
5. the complete data dossiers of the evaluation
serving or having served for entry in Annex I,IA or IB shall be put at the disposal of theCommittee referred to in Article 28(3).
(iii) A decision to remove an Annex I entry shall not
have immediate effect but shall be delayed for aperiod of up to a maximum of four years fromthe date of that decision.EN Official Journal of the European Communities L 123/13 24.4.98
Article 11
Procedure for inclusion of an active substance in Annex I,
IA or IB
1. Inclusion, or subsequent changes to the inclusion, of
an active substance in Annex I, IA or IB shall beconsidered when:
(a) an applicant has forwarded to the competent
authority of one of the Member States:
(i) a dossier for the active substance satisfying the
requirements of Annex IVA or the requirementsof Annex IIA and, where specified, the relevantparts of Annex IIIA;
(ii) a dossier for at least one biocidal product
containing the active substance satisfying therequirements of Article 8, with the exception ofparagraph 3 thereof;
(b) the receiving competent authority has verified the
dossiers and believes them to satisfy the requirementsof Annex IVA and Annex IVB or the requirements ofAnnex IIA and Annex IIB and, where relevant,Annexes IIIA and IIIB, accepts them and agrees tothe applicant forwarding a summary of the dossiersto the Commission and the other Member States.
2. The receiving competent authority shall, within 12
months of accepting the dossiers, carry out an evaluationthereof. A copy of the evaluation shall be sent by thecompetent authority to the Commission, the otherMember States and to the applicant, together with arecommendation for the inclusion, or otherwise, of theactive substance in Annex I, IA or IB.
If, when the dossiers are evaluated, it appears that further
information is necessary for full evaluation to be made,the receiving competent authority shall ask that theapplicant submit such information. The 12-month periodshall be suspended from the date of issue of thecompetent authority’s request until the date theinformation is received. The competent authority shallinform the other Member States and the Commission ofits action when it informs the applicant.
3. To avoid dossiers being evaluated by only a few
Member States, the evaluation can be carried out byMember States other than the receiving one. A requestfor this shall be given when the dossiers are accepted, andthe decision shall be taken in accordance with theprocedure laid down in Article 28(2). The decision shallbe taken at the latest one month after receipt by theCommission of the request.
4. On receipt of the evaluation, the Commission shall,
in accordance with the procedure in Article 27, prepare aproposal without undue delay for decision in accordancewith the procedure laid down in Article 28(3). Thedecision shall be taken at the latest 12 months after the
receipt by the Commission of the evaluation referred toin paragraph 2.
Article 12
Use of data held by competent authorities for other
applicants
1. Member States shall not make use of the
information referred to in Article 8 for the benefit of asecond or subsequent applicant:
(a) unless the second or subsequent applicant has the
written agreement in the form of a letter of access ofthe first applicant that use may be made of suchinformation, or
(b) in the case of an active substance not on the market
on the date referred to in Article 34(1), for a periodof 15 years from the date of first inclusion inAnnex I or IA, or
(c) in the case of an active substance already on the
market on the date referred to in Article 34(1):
(i) for a period of 10 years from the date referred
to in Article 34(1) for any informationsubmitted for the purposes of this Directive,except where such information is alreadyprotected under existing national rules relatingto biocidal products. In such cases, theinformation shall continue to be protected inthat Member State until the expiry of anyremaining period of data protection providedfor under national rules, up to a maximum of10 years from the date referred to inArticle 34(1);
(ii) for a period of 10 years from the date of entry
of an active substance onto Annex I or IA forinformation submitted for the first time insupport of the first inclusion in Annex I or IA ofeither the active substance or an additionalproduct type for that active substance,
(d) in the case of any further information submitted for
the first time for any of the following:
(i) variation of the requirements of the entry on
Annex I or IA;
(ii) maintenance of the entry of Annex I or IA
for a period of five years from the date of decision
following receipt of further information unless thefive-year period expires before the period providedfor in paragraphs 1(b) and (c), in which case theperiod of five years shall be extended so as to expireon the same date as those periods.EN Official Journal of the European Communities L 123/14 24.4.98
2. Member States shall not make use of the
information referred to in Article 8, for the benefit of asecond or subsequent applicant:
(a) unless the second or subsequent applicant has the
written agreement in the form of a letter of access ofthe first applicant that use may be made of suchinformation; or
(b) in the case of a biocidal product containing an active
substance not on the market on the date referredto in Article 34(1) for a period of 10 years fromthe date of first authorisation in any Member State,or;
(c) in the case of a biocidal product containing an active
substance already on the market on the date referredto in Article 34(1);
(i) for a period of 10 years from the date referred
to in Article 34(1) for any informationsubmitted for the purposes of this Directive,except in the case where data are alreadyprotected according to existing national rulesrelating to biocidal products, in which case suchdata shall be protected in that Member Stateuntil the expiry of any remaining period of dataprotection provided for under those nationalrules, up to a maximum of 10 years from thedate referred to in Article 34(1);
(ii) for a period of 10 years from the date of entry
of an active substance onto Annex I or IA, forinformation which is submitted for the first timein support of the inclusion in Annex I or IAeither of the active substance or of an additionalproduct type for that active substance;
(d) in the case of any data submitted for the first time
for either of the following:
(i) variation of the conditions of authorisation of a
biocidal product;
(ii) submission of data necessary to maintain entry
of an active substance onto Annex I or IA
for a period of five years from the date of first
receipt of further information, unless the five-yearperiod expires before the period in paragraphs (b)and (c), in which case the period of five years shallbe extended so as to expire on the same date asthose periods.
3. For decisions to be taken in accordance with
Article 10(5), the information referred to in paragraphs 1and 2 can be used by the Commission, the ScientificCommittees as referred to in Article 27 and the MemberStates.Article 13
Cooperation in the use of data for second and subsequent
applications for authorisation
1. In the case of a biocidal product which has already
been authorised in accordance with Articles 3 and 5, andwithout prejudice to the obligations imposed pursuant toArticle 12, the competent authority may agree that asecond or subsequent applicant for authorisation mayrefer to data provided by the first applicant in so far asthe second or subsequent applicant can provide evidencethat the biocidal product is similar and its activesubstances are the same as the one formerly authorised,including degree of purity and nature of impurities.
2. Notwithstanding Article 8(2):
(a) an applicant for authorisation of biocidal products
shall, before carrying out experiments involvingvertebrate animals, enquire of the competentauthority of the Member State to which he intendsmaking application:
— whether the biocidal product for which an
application is to be made is similar to a biocidalproduct for which authorisation has beengranted, and
— as to the name and address of the holder or
holders of the authorisation or authorisations.
The enquiry shall be supported by evidence that the
prospective applicant intends to apply forauthorisation on his own behalf and that the otherinformation specified in Article 8(2) is available;
(b) the competent authority of the Member State, if
satisfied that the applicant intends to apply, shallprovide the name and address of the holder orholders of former relevant authorisations and shall atthe time inform the holders of the authorisations ofthe name and address of the applicant.
The holder or holders of former authorisations and
the applicant shall take all reasonable steps to reachagreement on the sharing of information, so as toavoid, if possible, the duplication of testing onvertebrate animals.
The competent authorities of the Member States shall
encourage data-holders to cooperate in the provision ofthe requested data, with a view to limiting theduplication of testing on vertebrate animals.
If it is still not possible for the applicant and holders of
former authorisations of the same product to reach anagreement on the sharing of data, Member States mayintroduce national measures obliging the applicant andholders of former authorisations located within theirEN Official Journal of the European Communities L 123/15 24.4.98
territory to share the data with a view to avoiding
duplicative testing on vertebrate animals and determineboth the procedure for utilising information, and thereasonable balance of the interests of the partiesconcerned.
Article 14
New information
1. Member States shall prescribe that the holder of an
authorisation for a biocidal product shall immediatelynotify the competent authority of information of whichhe or she is aware or of which he or she may reasonablybe expected to be aware concerning an active substanceor a biocidal product containing it and which may affectcontinuing authorisation. In particular, the followingshall be notified:
— new knowledge or information on the effects of the
active substance or biocidal product for humans orthe environment,
— changes in the source or composition of the active
substance,
— changes in composition of a biocidal product,— development of resistance,
— changes of an administrative nature or other aspects,
such as the nature of the packaging.
2. Member States shall immediately notify other
Member States and the Commission of any suchinformation they receive concerning potentially harmfuleffects for humans or the environment or the newcomposition of a biocidal product, its active substances,impurities, co-formulants or residues.
Article 15
Derogation from the requirements
1. By way of derogating from Articles 3 and 5, a
Member State may authorise temporarily for a period notexceeding 120 days, the placing on the market of biocidalproducts not complying with the provisions of thisDirective for a limited and controlled use if such ameasure appears necessary because of an unforseendanger which cannot be contained by other means. Inthis case, the Member State concerned shall immediatelyinform the other Member States and the Commission ofits action and the justification for it. The Commissionshall make a proposal and it shall be decided withoutdelay, in accordance with the procedure laid downin Article 28(2), whether, and, if so, under what
conditions, the action taken by the Member State may beextended for a period to be determined, be repeated, orbe revoked.
2. By way of derogation from Article 5(1)(a) and until
an active substance is listed in Annex I or IA, a MemberState may authorise provisionally, for a period notexceeding three years, the placing on the market of abiocidal product containing an active substance not listedin Annex I or IA and not yet available on the market onthe date referred to in Article 34(1) for purposes otherthan those defined in Article 2(2)(c) and (d). Such anauthorisation may be issued only if, after dossiers havebeen evaluated in accordance with Article 11, theMember State believes that:
— the active substance satisfies the requirements of
Article 10 and,
— the biocidal product may be expected to satisfy the
conditions of Articles 5(1)(b), (c) and (d),
and no other Member State, on the basis of the summary
it receives, makes legitimate objection, in accordance withArticle 18(2), to the completeness of the dossiers. Wherean objection is made, a decision on the completeness ofdossiers shall be taken in accordance with the procedurelaid down in Article 28(2) without undue delay.
If, following the procedures laid down in Articles 27 and
28(2), it is decided that the active substance does notsatisfy the requirements specified in Article 10, theMember State shall ensure that the provisionalauthorisation is cancelled.
In cases where evaluation of dossiers for the purposes of
inclusion of an active substance in Annex I or IA is notcompleted when the period of three years expires, thecompetent authority may further provisionally authorisethe product for a period not exceeding one year,providing there are good reasons to believe the activesubstance will satisfy the requirements of Article 10.Member States shall inform other Member States and theCommission of such action.
Article 16
Transitional measures
1. By way of further derogating from Articles 3(1),
5(1), 8(2) and 8(4), and without prejudice toparagraphs 2 and 3, a Member State may, for a period of10 years from the date referred to in Article 34(1),continue to apply its current system or practice of placingbiocidal products on the market. It may, in particular,according to its national rules, authorise the placing onthe market in its territory of a biocidal productEN Official Journal of the European Communities L 123/16 24.4.98
containing active substances not listed in Annex I or IA
for that product type. Such active substances must be onthe market on the date referred to in Article 34(1) asactive substances of a biocidal product for purposes otherthan those defined in Article 2(2)(c) and (d).
2. Following the adoption of this Directive, the
Commission shall commence at 10-year programme ofwork for the systematic examination of all activesubstances already on the market on the date referred toin Article 34(1) as active substances of a biocidal productfor purposes other than those defined in Article 2(2)(c)and (d). A Regulation, adopted according to theprocedure laid down in Article 28(3), will provide forall provisions necessary for the establishment andimplementation of the programme including the setting ofpriorities for the evaluation of the different activesubstances and a timetable. No later than two yearsbefore completion of the work programme, theCommission shall forward to the European Parliamentand the Council a report on the progress achieved withthe programme.
During that 10-year period and from the date referred to
in Article 34(1), it may be decided pursuant to theprocedure laid down in Article 28(3) that an activesubstance shall be included in Annexes I, IA or IB andunder which conditions, or, in cases where therequirements of Article 10 are not satisfied or therequisite information and data have not been submittedwithin the prescribed period, that such active substanceshall not be included in Annex I, IA or IB.
3. Following such a decision to include or not to
include an active substance in Annex I, IA or IB, MemberStates shall ensure that authorisations or, where relevant,registrations for biocidal products containing the activesubstances and complying with the provisions of thisDirective are granted, modified or cancelled asappropriate.
4. Where, following a review of an active substance, it
is concluded that the substance does not meet therequirements of Article 10 and consequently cannot beincluded in Annex I, IA or IB, the Commission shallbring forward proposals for restricting the marketing anduse of that substance in accordance with Directive76/769/EEC.
5. The provisions of Council Directive 83/189/EEC of
28 March 1983 laying down a procedure for theprovision of information in the field of technicalstandards and Regulations(
1) shall continue to apply
during the transitional period referred to inparagraph 2.
(1) OJ L 109, 26.4.1983, p. 8. Directive as last amended by
Directive 94/10/EC (OJ L 100, 19.4.1994, p. 30).Article 17
Research and development
1. By way of derogation from Article 3, Member
States shall prescribe that any experiment or test for thepurposes of research or development involving theplacing on the market of an unauthorized biocidalproduct or an active substance intended exclusively foruse in a biocidal product shall not take place unless:
(a) in the case of scientific research and development,
the persons concerned draw up and maintain writtenrecords detailing the identity of the biocidal productor active substance, labelling data, quantitiessupplied and the names and addresses of thosepersons receiving the biocidal product or activesubstance and compile a dossier containing allavailable data on possible effects on human oranimal health or impact on the environment. Thisinformation shall, if requested, be made available tothe competent authority,
(b) in the case of process-oriented research and
development, the information required in (a) isnotified to the competent authority where and beforeplacing on the market occurs and to the competentauthority of the Member State where the experimentor test is to be conducted.
2. Member States shall prescribe that an unauthorised
biocidal product or an active substance for exclusive usein a biocidal product may not be placed on the marketfor the purpose of any experiment or test which mayinvolve, or result in, release into the environment unlessthe competent authority has assessed the available dataand issued an authorisation for this purpose which limitsthe quantities to be used and the areas to be treated andmay impose further conditions.
3. Where any experiment or test takes place in a
Member State other than the Member State whereplacing on the market occurs, the applicant shall obtainexperiments or tests authorisation from the competentauthority of the Member State in the territory of whichthe experiments or tests are to be conducted.
If the proposed experiments or tests referred to in
paragraphs 1 and 2 are liable to have harmful effects onhuman or animal health or to have an unacceptableadverse influence on the environment, the Member Stateconcerned may either prohibit them or only allow themsubject to such conditions as it considers necessary toprevent those consequences.EN Official Journal of the European Communities L 123/17 24.4.98
4. Paragraph 2 shall not apply if the Member State has
granted the person concerned the right to undertakecertain experiments and tests and has determined theconditions under which the experiments and tests have tobe undertaken.
5. Common conditions for the application of this
Article, in particular the maximum quantities of activesubstances or biocidal products that may be releasedduring experiments, and the minimum data to besubmitted in accordance with paragraph 2, shall beadopted in accordance with the procedure laid down inArticle 28(2).
Article 18
Information exchange
1. Within a period of one month from the end of each
quarter, Member States shall inform each other and theCommission of any biocidal products which have beenauthorised or registered within their territory or forwhich an authorisation or registration has been refused,modified, renewed or cancelled, indicating at least:
(a) the name or business name of the applicant for, or
the holder of, the authorisation or registration;
(b) the trade name of the biocidal product;(c) the name and amount of each active substance which
it contains, as well as the name and amount of eachdangerous substance in the meaning of Article 2(2)of Directive 67/548/EEC and their classification;
(d) the product-type and the use or uses for which it is
authorised;
(e) the type of formulation;(f) any proposed limits on residues which have been
established;
(g) conditions of the authorisation and where relevant,
the reasons for the modification or cancellation of anauthorisation;
(h) an indication of whether the product is of a special
type (e.g. within a frame-formulation, low-riskbiocidal product).
2. Where a Member State receives a summary of the
dossiers in accordance with Articles 11(1)(b) and 15(2)and has legitimate reason to believe the dossiers areincomplete, it shall immediately communicate itsconcerns to the competent authority responsible for theevaluation of the dossiers and shall without undue delayinform the Commission and other Member States of itsconcerns.
3. Each Member State shall draw up an annual list of
the biocidal products authorised or registered in itsterritory and shall communicate that list to the otherMember States and the Commission.4. In accordance with the procedure laid down in
Article 28(2), a standardised information system shall beset up to facilitate the application of paragraphs 1 and2.
5. The Commission shall draw up a report on the
implementation of this Directive and, in particular,on the functioning of the simplified procedures(frame-formulations, low-risk biocidal products andcommodity substances) seven years after the datementioned in Article 34(1). The Commission shall submitthe report to the Council, accompanied by proposals ifnecessary.
Article 19
Confidentiality
1. Without prejudice to Council Directive 90/313/EEC
of 7 June 1990 on the freedom of access to informationon the environment(
1), an applicant may indicate to the
competent authority the information which he considersto be commercially sensitive and disclosure of whichmight harm him industrially or commercially and whichhe therefore wishes to be kept confidential from allpersons other than the competent authorities and theCommission. Full justification will be required in eachcase. Without prejudice to the information referred to inparagraph 3 and the provisions of Directives 67/548/EECand 88/379/EEC, Member States shall take the necessarysteps to ensure the confidentiality of the full compositionof product formulations if requested by the applicant.
2. The competent authority receiving the application
shall decide, on the basis of documentary evidenceproduced by the applicant, which information shall beconfidential within the terms of paragraph 1.
Information accepted as being confidential by the
receiving competent authority shall be treated as beingconfidential by the other competent authorities, MemberStates and the Commission.
3. After the authorisation has been granted,
confidentiality shall not in any case apply to:
(a) the name and address of the applicant;(b) the name and address of the biocidal product
manufacturer;
(c) the name and address of the active substance
manufacturer;
(d) the names and content of the active substance or
substances in the biocidal product and the name ofthe biocidal product;
(1) OJ L 158, 6.10.1990, p. 40.EN Official Journal of the European Communities L 123/18 24.4.98
(e) the names of other substances which are regarded
as dangerous within the meaning of Directive67/548/EEC and contribute to the classification ofthe product;
(f) physical and chemical data concerning the active
substance and biocidal product;
(g) any ways of rendering the active substance or
biocidal product harmless;
(h) a summary of the results of the tests required
pursuant to Article 8 to establish the substance’s orproduct’s efficacy and effects on humans, animalsand the environment and, where applicable, itsability to promote resistance;
(i) recommended methods and precautions to reduce
dangers from handling, storage, transport and use aswell as from fire or other hazards;
(j) safety data sheets;(k) methods of analysis referred to in Article 5(1)(c);(l) methods of disposal of the product and of its
packaging;
(m) procedures to be followed and measures to be taken
in the case of spillage or leakage;
(n) first aid and medical advice to be given in the case of
injury to persons.
If the applicant or manufacturer or importer of the
biocidal product or active substance should later disclosepreviously confidential information, the competentauthority shall be informed accordingly.
4. The detailed provisions and format for making
information publicly available and for implementing thisArticle shall be decided in accordance with theprocedures set out in Article 28(2).
Article 20
Classification, packaging and labelling of biocidal
products
1. Biocidal products shall be classified in accordance
with the provisions relating to classification in Directive88/379/EEC.
2. Biocidal products shall be packaged in accordance
with Article 6 of Directive 88/379/EEC. In addition:
(a) products which may be mistaken for food, drink or
feedingstuff shall be packaged to minimize thelikelihood of such a mistake being made;(b) products available to the general public which
may be mistaken for food, drink or feedingstuffshall contain components to discourage theirconsumption.
3. Biocidal products shall be labelled in accordance
with the provisions relating to labelling in Directive88/379/EEC. Labels shall not be misleading or give anexaggerated impression of the product and, in any case,not mention the indications ‘low-risk biocidal product’,‘non-toxic’, ‘harmless’ or similar indications. In addition,the label must show clearly and indelibly the following:
(a) the identity of every active substance and its
concentration in metric units;
(b) the authorisation number allocated to the biocidal
product by the competent authority;
(c) the type of preparation (e.g. liquid concentrates,
granules, powders, solids, etc.);
(d) the uses for which the biocidal product is authorised
(e.g. wood preservation, disinfection, surface biocide,anti-fouling, etc.);
(e) directions for use and the dose rate, expressed in
metric units, for each use provided for under theterms of the authorisation;
(f) particulars of likely direct or indirect adverse side
effects and any directions for first aid;
(g) if accompanied by a leaflet, the sentence ‘Read
attached instructions before use’;
(h) directions for safe disposal of the biocidal product
and its packaging, including, where relevant, anyprohibition on reuse of packaging;
(i) the formulation batch number or designation and the
expiry date relevant to normal conditions ofstorage;
(j) the period of time needed for the biocidal effect, the
interval to be observed between applications of thebiocidal product or between application and the nextuse of the product treated, or the next access by manor animals to the area where the biocidal producthas been used, including particulars concerningdecontamination means and measures and durationof necessary ventilation of treated areas; particularsfor adequate cleaning of equipment; particularsconcerning precautionary measures during use,storage and transport (e.g. personal protectiveclothing and equipment, measures for protectionEN Official Journal of the European Communities L 123/19 24.4.98
against fire, covering of furniture, removal of food
and feedingstuff and directions to prevent animalsfrom being exposed);
and where applicable:(k) the categories of users to which the biocidal product
is restricted;
(l) information on any specific danger to the
environment particularly concerning protectionof non-target organisms and avoidance ofcontamination of water;
(m) for microbiological biocidal products, labelling
requirements according to Council Directive90/679/EEC of 26 November 1990 on the protectionof workers from risks related to exposure tobiological agents at work(
1).
Member States shall require that items 3(a), (b), (d) and
where applicable (g) and (k) always be carried on thelabel of the product.
Member States shall permit items 3(c), (e), (f), (h), (i), (j)
and (l) to be carried elsewhere on the packaging or on anaccompanying leaflet integral to the packaging. Theseitems of information shall be regarded as labelinformation for the purposes of this Directive.
4. Where a biocidal product identified as insecticide,
acaricide, rodenticide, avicide or molluscicide isauthorised pursuant to this Directive and is also subjectto classification, packaging and labelling according toCouncil Directive 78/631/EEC of 26 June 1978 on theapproximation of the laws of the Member States relatingto the classification, packaging and labelling of dangerouspreparations (pesticides)(
2) by virtue of other Community
provisions, Member States shall permit changes to thepackaging and labelling of that product which may berequired as a consequence of those provisions in so far asthey do not conflict with the conditions of anauthorisation issued under this Directive.
5. Member States may require the provision of
samples, models or drafts of the packaging, labelling andleaflets.
6. Member States shall make the placing of biocidal
products on the market in their territories subject to thembeing labelled in their national language or languages.
(1) OJ L 374, 31.12.1990, p. 1. Directive as last amended by
Directive 95/30/EC (OJ L 155, 6.7.1995, p. 5).
(2) OJ L 206, 29.7.1978, p. 13. Directive as last amended by
Directive 92/32/EEC (OJ L 154, 5.6.1992, p. 1).Article 21
Safety-data sheets
Member States shall take the necessary measures to
ensure that a system of specific information is establishedto enable professional and industrial users and, asappropriate, other users of biocidal products to take thenecessary measures for the protection of the environmentand health as well as health and safety at the workplace.This shall be done in the form of a safety-data sheetprovided by those responsible for the placing on themarket of the product.
The safety-data sheets shall be prepared:
— for biocidal products classified as dangerous and in
accordance with Article 10 of Directive 88/379/EEC,
— for active substancess used exclusively in biocidal
products in accordance with the requirements ofArticle 27 of Directive 67/548/EEC.
Article 22
Advertising
1. Member States shall require that every
advertisement for a biocidal product is accompanied bythe sentences ‘Use biocides safely. Always read the labeland product information before use’.
The sentences shall be clearly distinguishable in relation
to the whole advertisement.
Member States shall prescribe that advertisers may
replace the word ‘Biocides’ in the prescribed sentenceswith an accurate description of the product-type beingadvertised, for example wood preservatives, disinfectants,surface biocides, anti-fouling products, etc.
2. Member States shall require that advertisements for
biocidal products do not refer to the product in a mannerwhich is misleading in respect of the risks from theproduct to man or the environment.
Under no circumstances may the advertising of a biocidal
product mention ‘low-risk biocidal product’, ‘non-toxic’,‘harmless’ or any similar indications.
Article 23
Poison control
Member States shall appoint a body or bodies responsible
for receiving information on biocidal products whichEN Official Journal of the European Communities L 123/20 24.4.98
have been placed on the market, including information
on the chemical composition of such products, and formaking such information available in cases wheresuspected poisoning arises from biocidal products. Suchinformation may only be used to meet any medicaldemand by formulating preventive and curative measures,in particular in emergencies. Member States shall ensurethat the information is not used for other purposes.
Member States shall take the necessary steps to ensure
that the appointed bodies provide all the requisiteguarantees for maintaining the confidentiality of theinformation received. Member States shall ensure that theappointed bodies have at their disposal all theinformation required to carry out the tasks for whichthey are responsible from the manufacturers or personsresponsible for marketing.
For biocidal products already on the market on the date
referred to in Article 34(1), Member States shall takemeasures to comply with this Article within three years ofthe date referred to Article 34(1).
Article 24
Compliance with requirements
Member States shall take the necessary arrangements for
biocidal products which have been placed on the marketto be monitored to establish whether they comply withthe requirements of this Directive.
Every three years after the date referred to in
Article 34(1), Member States shall forward to theCommission by 30 November of the third year a reporton their action in these matters together with informationon any poisonings involving biocidal products. TheCommission shall within one year of receipt of thisinformation prepare and publish a composite report.
Article 25
Charges
Member States shall establish systems obliging those
having placed or seeking to place biocidal products onthe market and those supporting entries for activesubstances on Annexes I, IA or IB to pay charges,corresponding as far as possible to their costs in carryingout all the different procedures associated with theprovisions of this Directive.Article 26
Competent authorities
1. Member States shall designate a competent
authority or competent authorities responsible forcarrying out the duties imposed on Member Statespursuant to this Directive.
2. Member States shall inform the Commission of the
identity of their competent authority or competentauthorities, not later than the date referred to inArticle 34(1).
Article 27
Commission procedures
1. When the Commission receives from a Member
State either:
(a) an evaluation and recommendations concerning an
active substance in accordance with Article 11(2)and/or an assessment according to Article 10(5), or
(b) a proposal to refuse an authorisation or a
registration and an explanatory document inaccordance with Article 4(4),
it shall allow a period of 90 days during which other
Member States and the applicant may submit commentsto it in writing.
2. At the end of the period for comment, the
Commission shall, on the basis of:
— the documents received from the Member State
evaluating the dossiers and,
— any advice obtained from advisory scientific
committees,
— comments received from other Member States and the
applicants and,
— any other relevant information,prepare a draft for decision in accordance with the
relevant procedures laid down in Article 28(2) or 28(3).
3. The Commission shall ask the applicant and/or his
authorised representative to submit remarks to it, unlessa favourable decision is envisaged.
Article 28
Committees and procedures
1. The Commission shall be assisted by a Standing
Committee on Biocidal Products (the StandingEN Official Journal of the European Communities L 123/21 24.4.98
Committee). The Standing Committee shall be composed
of representatives of the Member States and chaired by arepresentative of the Commission. The StandingCommittee shall adopt its own rules of procedure.
2. For matters referred to the Standing Committee by
virtue of Articles 4, 11(3), 15, 17, 18, 19, 27(1)(b), 29and 33 and the elaboration of specific data by producttype referred to in Annex V, to be drawn fromAnnexes IIIA and IIIB and, as appropriate, fromAnnexes IVA and IVB, the representative of theCommission shall submit to the committee a draft of themeasures to be taken. The committee shall deliver itsopinion on the draft within a time limit which thechairman may lay down according to the urgency of thematter. The opinion shall be delivered by the majoritylaid down in Article 148(2) of the Treaty in the caseof decisions which the Council is required to adopton a proposal from the Commission. The votes ofthe representatives of the Member States within thecommittee shall be weighted in the manner set out in thatArticle. The chairman shall not vote.
The Commission shall adopt the measures envisaged
which shall apply immediately. However, if thesemeasures are not in accordance with the opinion of theCommittee, they shall be communicated by theCommission to the Council forthwith. In that event:
The Commission shall defer application of the measures
which it has decided for a period of three months fromthe date of communication.
The Council, acting by a qualified majority, may take a
different decision within the time limit referred to in theprevious subparagraph.
3. For matters referred to the Standing Committee by
virtue of Articles 10, 11(4), 16, 27(1)(a) and (2), and 32,the representative of the Commission shall submit to thecommittee a draft of the measures to be taken. Thecommittee shall deliver its opinion on the draft within atime limit which the chairman may lay down accordingto the urgency of the matter. The opinion shall bedelivered by the majority laid down in Article 148(2) ofthe Treaty in the case of decisions which the Council isrequired to adopt on a proposal from the Commission.The votes of the representatives of the Member Stateswithin the committee shall be weighted in the manner setout in that Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged if
they are in accordance with the opinion of thecommittee.
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 theCouncil 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 proposedmeasures shall be adopted by the Commission, savewhere the Council has decided against the said measuresby a simple majority.
Article 29
Adaptation to technical progress
The amendments necessary for adapting Annexes IIA,
IIB, IIIA, IIIB, IVA and IVB, the descriptions of theproduct-types in Annex V to technical progress and forspecifying data requirements for each of these producttypes, shall be adopted in accordance with the procedurelaid down in Article 28(2).
Article 30
Modification or adaptation of Annexes V and VI
Acting on a proposal from the Commission, the Council
and the European Parliament shall, in accordance withthe procedures laid down in the Treaty, modify or adaptto technical progress the titles of the product-types ofAnnex V and the provisions of Annex VI.
Article 31
Civil and criminal liability
The granting of authorisation and all other measures in
conformity with this Directive shall be without prejudiceto general civil and criminal liability in the MemberStates of the manufacturer and, where applicable, of theperson responsible for placing the biocidal product on themarket or using it.
Article 32
Safeguard clause
Where a Member State has valid reasons to consider that
a biocidal product which it has authorised, registered oris bound to authorise or register pursuant to Articles 3 or4, constitutes an unacceptable risk to human or animalhealth or the environment, it may provisionally restrict orprohibit the use or sale of that product on its territory. Itshall immediately inform the Commission and the otherMember States of such action and give reasons for itsEN Official Journal of the European Communities L 123/22 24.4.98
decision. A decision shall be taken on the matter within
90 days in accordance with the procedure laid down inArticle 28(3).
Article 33
Technical notes for guidance
The Commission, in accordance with the procedure laid
down in Article 28(2), shall draw up technical notes forguidance to facilitate the day-to-day implementation ofthis Directive.
These technical notes shall be published in the ‘C’ series
of the Official Journal of the European Communities.
Article 34
Implementation of the Directive
1. Member States shall bring into force the laws,
regulations and administrative provisions necessary tocomply with this Directive not later than 24 months afterits entry into force. They shall forthwith inform theCommission thereof.
2. When Member States adopt these measures, they
shall contain a reference to this Directive or shall beaccompanied by such reference on the occasion of their
official publication. The methods of making such areference shall be laid down by the Member States.
3. Member States shall communicate to the
Commission the texts of the provisions of national lawwhich they adopt in the field covered by this Directive.
Article 35
This Directive shall enter into force on the 20th day
following its publication.
Article 36
This Directive is addressed to the Member States.
Done at Brussels, 16 February 1998.
For the European Parliament
The President
J. M. GIL-ROBLESFor the Council
The President
J. CUNNINGHAMEN Official Journal of the European Communities L 123/23 24.4.98
ANNEX I
LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL FOR
INCLUSION IN BIOCIDAL PRODUCTS
ANNEX IA
LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVEL FOR
INCLUSION IN LOW-RISK BIOCIDAL PRODUCTS
ANNEX IB
LIST OF BASIC SUBSTANCES WITH REQUIREMENTS AGREED AT COMMUNITY LEVELEN Official Journal of the European Communities L 123/24 24.4.98
ANNEX IIA
COMMON CORE DATA SET FOR ACTIVE SUBSTANCES
CHEMICAL SUBSTANCES
1. Dossiers on active substances are required to address at least all the points listed under ‘Dossier
requirements’. Responses are required to be supported by data. The dossier requirements must be in linewith technical development.
2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses
need not be supplied. The same applies where it is not scientifically necessary or technically possible tosupply the information. In such cases a justification, acceptable to the competent authority must besubmitted. Such a justification may be the existence of a frame-formulation to which the applicant hasthe right of access.
Dossier requirements
I. Applicant
II. Identity of the active substance
III. Physical and chemical properties of the active substance
IV. Methods of detection and identification
V. Effectiveness against target organisms and intended uses
VI. Toxicological profile for man and animals including metabolism
VII. Ecotoxicological profile including environmental fate and behaviour
VIII. Measures necessary to protect man, animals and the environment
IX. Classification and labelling
X. Summary and evaluation of Sections II to IX
The following data will be required to support submission on the above points.
I. APPLICANT
1.1. Name and address, etc.1.2. Active substance manufacturer (name, address, location of plant)
II. IDENTITY
2.1. Common name proposed or accepted by ISO and synonyms2.2. Chemical name (IUPAC nomenclature)2.3. Manufacturer’s development code number(s)2.4. CAS and EC numbers (if available)
2.5. Molecular and structural formula (including full details of any isomeric composition), molecular
mass
2.6. Method of manufacture (syntheses pathway in brief terms) of active substance2.7. Specification of purity of the active substance in g/kg or g/l, as appropriateEN Official Journal of the European Communities L 123/25 24.4.98
2.8. Identity of impurities and additives (e.g. stabilisers), together with the structural formula and the
possible range expressed as g/kg or g/l, as appropriate
2.9. The origin of the natural active substance or the precursor(s) of the active substance, e.g. an
extract of a flower
2.10. Exposure data in conformity with Annex VIIA to Directive 92/32/EEC(*).
III. PHYSICAL AND CHEMICAL PROPERTIES
3.1. Melting point, boiling point, relative density(1)
3.2. Vapour pressure (in Pa)(1)
3.3. Appearance (physical state, colour)(2)
3.4. Absorption spectra (UV/VIS, IR, NMR), and a mass spectrum, molar extinction at relevant
wavelengths, where relevant(1)
3.5. Solubility in water including effect of pH (5 to 9) and temperature on solubility, where
relevant(1)
3.6. Partition coefficient n-octanol/water including effect of pH (5 to 9) and temperature(1)
3.7. Thermal stability, identity of relevant breakdown products3.8. Flammability including auto-flammability and identity of combustion products3.9. Flash-point3.10. Surface tension3.11. Explosive properties3.12. Oxidising properties3.13. Reactivity towards container material
IV. ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION
4.1. Analytical methods for the determination of pure active substance and, where appropriate, for
relevant degradation products, isomers and impurities of the active substance and additives (e.g.stabilisers)
4.2. Analytical methods including recovery rates and the limits of determination for the active
substance, and for residues thereof, and where relevant in/on the following:
(a) Soil(b) Air(c) Water: the applicant should confirm that the substance itself and any of its degradation
products which fall within the definition of pesticides given for parameter 55 in Annex I toCouncil Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended forhuman consumption(**) can be estimated with adequate reliability at the MAC specified inthat Directive for individual pesticides
(d) Animal and human body fluids and tissues
(*) OJ L 154, 5.6.1992, p. 1.
(**) OJ L 229, 30.8.1980, p. 11. Directive as last amended by Directive 91/692/EEC (OJ L 377, 31.12.1991, p. 48).EN Official Journal of the European Communities L 123/26 24.4.98
V. EFFECTIVENESS AGAINST TARGET ORGANISMS AND INTENDED USES
5.1. Function, e.g. fungicide, rodenticide, insecticide, bactericide5.2. Organism(s) to be controlled and products, organisms or objects to be protected5.3. Effects on target organisms, and likely concentration at which the active substance will be used5.4. Mode of action (including time delay)5.5. Field of use envisaged
5.6. User: industrial, professional, general public (non-professional)5.7. Information on the occurrence or possible occurrence of the development of resistance and
appropriate management strategies
5.8. Likely tonnage to be placed on the market per year
VI. TOXICOLOGICAL AND METABOLIC STUDIES
6.1. Acute toxicity
For studies 6.1.1 to 6.1.3, substances other than gases shall be administered via at least two
routes, one of which should be the oral route. The choice of the second route will depend on thenature of the substance and the likely route of human exposure. Gases and volatile liquids shouldbe administered by the inhalation route.
6.1.1. Oral6.1.2. Dermal6.1.3. Inhalation6.1.4. Skin and eye irritation(
3)
6.1.5. Skin sensitisation
6.2. Metabolism studies in mammals. Basic toxicokinetics, including a dermal absorption study
For the following studies, 6.3 (where necessary), 6.4, 6.5, 6.7 and 6.8, the required route of
administration is the oral route unless it can be justified that an alternative route is moreappropriate
6.3. Short-term repeated dose toxicity (28 days)
This study is not required when a sub-chronic toxicity study is available in a rodent
6.4. Subchronic toxicity 90-day study, two species, one rodent and one non-rodent6.5. Chronic toxicity(
4)
One rodent and one other mammalian species
6.6. Mutagenicity studies
6.6.1. In-vitro gene mutation study in bacteria
6.6.2. In-vitro cytogenicity study in mammalian cells
6.6.3. In-vitro gene mutation assay in mammalian cells
6.6.4. If positive in 6.6.1, 6.6.2 or 6.6.3, then an in-vivo mutagenicity study will be required (bone
marrow assay for chromosomal damage or a micronucleus test)
6.6.5. If negative in 6.6.4 but positive in-vitro tests then undertake a second in-vivo study to examine
whether mutagenicity or evidence of DNA damage can be demonstrated in tissue other than bonemarrowEN Official Journal of the European Communities L 123/27 24.4.98
6.6.6. If positive in 6.6.4 then a test to assess possible germ cell effects may be required
6.7. Carcinogenicity study(4)
One rodent and one other mammalian species. These studies may be combined with those in
6.5
6.8. Reproductive toxicity(5)
6.8.1. Teratogenicity test — rabbit and one rodent species6.8.2. Fertility study — at least two generations, one species, male and female
6.9. Medical data in anonymous form
6.9.1. Medical surveillance data on manufacturing plant personnel if available6.9.2. Direct observation, e.g. clinical cases, poisoning incidents if available
6.9.3. Health records, both from industry and any other available sources6.9.4. Epidemiological studies on the general population, if available6.9.5. Diagnosis of poisoning including specific signs of poisoning and clinical tests, if available6.9.6. Sensitisation/allergenicity observations, if available6.9.7. Specific treatment in case of an accident or poisoning: first aid measures, antidotes and medical
treatment, if known
6.9.8. Prognosis following poisoning
6.10. Summary of mammalian toxicology and conclusions, including no observed adverse effect level
(NOAEL), no observed effect level (NOEL), overall evaluation with regard to all toxicological dataand any other information concerning the active substances. Where possible any suggested workerprotection measures should be included in summary form
VII. ECOTOXICOLOGICAL STUDIES
7.1. Acute toxicity to fish7.2. Acute toxicity to Daphnia magna
7.3. Growth inhibition test on algae
7.4. Inhibition to microbiological activity7.5. Bioconcentration
Fate and behaviour in the environment
7.6. Degradation
7.6.1. Biotic
7.6.1.1. Ready biodegradability7.6.1.2. Inherent biodegradability, where appropriate
7.6.2. Abiotic
7.6.2.1. Hydrolysis as a function of pH and identification of breakdown products7.6.2.2. Phototransformation in water including identity of the products of transformation(
1)
7.7. Adsorption/desorption screening test
Where the results of this test indicate the need to do so, the test described in Annex IIIA Part XII.1
paragraph 1.2 shall be required, and/or the test described in Annex IIIA Part XII.2paragraph 2.2
7.8. Summary of ecotoxicological effects and fate and behaviour in the environmentEN Official Journal of the European Communities L 123/28 24.4.98
VIII. MEASURES NECESSARY TO PROTECT MAN, ANIMALS AND THE ENVIRONMENT
8.1. Recommended methods and precautions concerning handling, use, storage, transport or fire8.2. In case of fire, nature of reaction products, combustion gases, etc.8.3. Emergency measures in case of an accident8.4. Possibility of destruction or decontamination following release in or on the following: (a) air
(b) water, including drinking water (c) soil
8.5. Procedures for waste management of the active substance for industry or professional users
8.5.1. Possibility of reuse or recycling8.5.2. Possibility of neutralisation of effects8.5.3. Conditions for controlled discharge including leachate qualities on disposal8.5.4. Conditions for controlled incineration
8.6. Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target
organisms
IX. CLASSIFICATION AND LABELLING
Proposals including justification for the proposals for the classification and labelling of the active
substance according to Directive 67/548/EEC
Hazard symbol(s)Indications of dangerRisk phrasesSafety phrases
X. SUMMARY AND EVALUATION OF SECTIONS II TO IX
Notes
(
1) These data must be submitted for the purified active substance of stated specification.
(2) These data must be submitted for the active substance of stated specification.
(3) Eye irritation test shall not be necessary where the active substance has been shown to have potential
corrosive properties.
(4) The long-term toxicity and carcinogenicity of an active substance may not be required where a full
justification demonstrates that these tests are not necessary.
(5) If, in exceptional circumstances, it is claimed that such testing is unnecessary, that claim must be fully
justified.EN Official Journal of the European Communities L 123/29 24.4.98
ANNEX IIB
COMMON CORE DATA SET FOR BIOCIDAL PRODUCTS
CHEMICAL PRODUCTS
1. Dossiers on biocidal products are required to address at least all the points listed under ‘Dossier
requirements’. Responses are required to be supported by data. The dossier requirements must be in linewith technical development.
2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses
need not be supplied. The same applies where it is not scientifically necessary or technically possible tosupply the information. In such cases a justification, acceptable to the competent authority must besubmitted. Such a justification may be the existence of a frame-formulation to which the applicant hasthe right of access.
3. Information may be derived from existing data where a justification acceptable to the competent
authority is provided. In particular, the provisions of Directive 88/379/EEC should be used whereverpossible to minimise animal testing.
Dossier requirements
I. Applicant
II. Identity of the biocidal product
III. Physical and chemical properties of the biocidal product
IV. Methods for identification and analysis of the biocidal product
V. Intended uses of the biocidal product and efficacy for these uses
VI. Toxicology data for the biocidal product (additional to that for the active substance)
VII. Ecotoxicology data for the biocidal product (additional to that for the active substance)
VIII. Measures necessary to protect man, animals and the environment
IX. Classification, packaging and labelling
X. Summary and evaluation of Sections II to IX
The following data will be required to support submission on the above points.
I. APPLICANT
1.1. Name and address, etc.1.2. Formulator of the biocidal product and the active substance(s) (names, addresses, including location
of plant(s))
II. IDENTITY
2.1. Trade name or proposed trade name, and manufacturer’s development code number of the
preparation, if appropriate
2.2. Detailed quantitative and qualitative information on the composition of the biocidal product, e.g.
active substance(s), impurities, adjutants, inert components
2.3. Physical state and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder,
solutionEN Official Journal of the European Communities L 123/30 24.4.98
III. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES
3.1. Appearance (physical state, colour)3.2. Explosive properties3.3. Oxidising properties3.4. Flash-point and other indications of flammability or spontaneous ignition3.5. Acidity/alkalinity and if necessary pH value (1% in water)3.6. Relative density3.7. Storage stability — stability and shelf-life. Effects of light, temperature and humidity on technical
characteristics of the biocidal product; reactivity towards container material
3.8. Technical characteristics of the biocidal product, e.g. wettability, persistent foaming, flowability,
pourability and dustability
3.9. Physical and chemical compatibility with other products including other biocidal products with
which its use is to be authorised
IV. METHODS OF IDENTIFICATION AND ANALYSIS
4.1. Analytical method for determining the concentration of the active substance(s) in the biocidal
product
4.2. In so far as not covered by Annex IIA, paragraph 4.2, analytical methods including recovery rates
and the limits of determination for toxicologically and ecotoxicologically relevant components of thebiocidal product and/or residues thereof, where relevant in or on the following:
(a) Soil(b) Air(c) Water (including drinking water)(d) Animal and human body fluids and tissues(e) Treated food or feedingstuffs
V. INTENDED USES AND EFFICACY
5.1. Product type and field of use envisaged5.2. Method of application including description of system used
5.3. Application rate and if appropriate, the final concentration of the biocidal product and active
substance in the system in which the preparation is to be used, e.g. cooling water, surface water,water used for heating purposes
5.4. Number and timing of applications, and where relevant, any particular information relating to
geographical variations, climatic variations, or necessary waiting periods to protect man andanimals
5.5. Function, e.g. fungicide, rodenticide, insecticide, bactericide5.6. Pest organism(s) to be controlled and products, organisms or objects to be protected5.7. Effects on target organisms5.8. Mode of action (including time delay) in so far as not covered by Annex IIA, paragraph 5.4EN Official Journal of the European Communities L 123/31 24.4.98
5.9. User: industrial, professsional, general public (non-professional)
Efficacy data
5.10. The proposed label claims for the product and efficacy data to support these claims, including any
available standard protocols used, laboratory tests, or field trials, where appropriate
5.11. Any other known limitations on efficacy including resistance
VI. TOXICOLOGICAL STUDIES
6.1. Acute toxicity
For studies 6.1.1 to 6.1.3, biocidal products other than gases shall be administered via at least two
routes, one of which should be the oral route. The choice of the second route will depend on thenature of the product and the likely route of human exposure. Gases and volatile liquids should beadministered by the inhalation route
6.1.1. Oral6.1.2. Dermal6.1.3. Inhalation6.1.4. For biocidal products that are intended to be authorised for use with other biocidal products, the
mixture of products, where possible, shall be tested for acute dermal toxicity and skin and eyeirritation, as appropriate
6.2. Skin and eye irritation(
1)
6.3. Skin sensitisation6.4. Information on dermal absorption6.5. Available toxicological data relating to toxicologically relevant non-active substances (i.e. substances
of concern)
6.6. Information related to the exposure of the biocidal product to man and the operator
Where necessary, the test(s) described in Annex IIA, shall be required for the toxicologically relevant
non-active substances of the preparation
VII. ECOTOXICOLOGICAL STUDIES
7.1. Foreseeable routes of entry into the environment on the basis of the use envisaged7.2. Information on the ecotoxicology of the active substance in the product, where this cannot be
extrapolated from the information on the active substance itself
7.3. Available ecotoxicological information relating to exotoxicological relevant non-active substances
(i.e. substances of concern), such as information from safety data sheets
VIII. MEASURES TO BE ADOPTED TO PROTECT MAN, ANIMALS AND THE ENVIRONMENT
8.1. Recommended methods and precautions concerning handling, use, storage, transport or fire8.2. Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical treatment if
available; emergency measures to protect the environment; in so far as not covered by Annex IIA,paragraph 8.3
8.3. Procedures, if any, for cleaning application equipmentEN Official Journal of the European Communities L 123/32 24.4.98
8.4. Identity of relevant combustion products in cases of fire
8.5. Procedures for waste management of the biocidal product and its packaging for industry,
professional users and the general public (non-professional users), e.g. possibility of reuse orrecycling, neutralisation, conditions for controlled discharge, and incineration
8.6. Possibility of destruction or decontamination following release in or on the following:
(a) Air(b) Water, including drinking water(c) Soil
8.7. Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target
organisms
8.8. Specify any repellents or poison control measures included in the preparation that are present to
prevent action against non-target organisms
IX. CLASSIFICATION, PACKAGING AND LABELLING
— Proposals for packaging and labelling— Proposals for safety-data sheets, where appropriate— Justification for the classification and labelling according to the principles of Article 20 of this
Directive
— Hazard symbol(s)— Indications of danger— Risk phrases— Safety phrases— Packaging (type, materials, size, etc.), compatibility of the preparation with proposed packaging
materials to be included
X. SUMMARY AND EVALUATION OF SECTIONS II TO IX
Notes
(
1) Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential
corrosive properties.EN Official Journal of the European Communities L 123/33 24.4.98
ANNEX IIIA
ADDITIONAL DATA SET FOR ACTIVE SUBSTANCES
CHEMICAL SUBSTANCES
1. Dossiers on active substances are required to address at least all the points listed under ‘Dossier
requirements’. Responses are required to be supported by data. The dossier requirements must be in linewith technical development.
2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses
need not be supplied. The same applies where it is not scientifically necessary or technically possible tosupply the information. In such cases a justification, acceptable to the competent authority must besubmitted. Such a justification may be the existence of a frame-formulation to which the applicant hasthe right of access.
III. PHYSICAL AND CHEMICAL PROPERTIES
1. Solubility in organic solvents, including effect of temperature on solubility(
1)
2. Stability in organic solvents used in biocidal products and identity of relevant breakdown
products(2)
IV. ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION
1. Analytical methods including recovery rates and the limits of determination for the active substance,
and for residues thereof, in/on food or feedstuffs and other products where relevant
VI. TOXICOLOGICAL AND METABOLIC STUDIES
1. Neurotoxicity study
If the active substance is an organophosphorus compound or if there are any other indications that the
active substance may have neurotoxic properties then neurotoxicity studies will be required. The testspecies is the adult hen unless another test species is justified to be more appropriate. If appropriate,delayed neurotoxicity tests will be required. If anticholine esterase activity is detected a test forresponse to reactivating agents should be considered
2. Toxic effects on livestock and pets3. Studies related to the exposure of the active substance to humans4. Food and feedingstuffs
If the active substance is to be used in preparations for use where food for human consumption is
prepared, consumed or stored, or where feedingstuff for livestock is prepared, consumed or stored thetests referred to in Section XI, part 1 shall be required
5. If any other tests related to the exposure of the active substance to humans, in its proposed biocidal
products, are considered necessary, then the test(s) referred to in Section XI, part 2 shall berequired
6. If the active substance is to be used in products for action against plants then tests to assess toxic
effects of metabolites from treated plants, if any, where different from those identified in animals shallbe required
7. Mechanistic study — any studies necessary to clarify effects reported in toxicity studiesEN Official Journal of the European Communities L 123/34 24.4.98
VII. ECOTOXICOLOGICAL STUDIES
1. Acute toxicity test on one other, non-aquatic, non-target organism2. If the results of the ecotoxicological studies and the intended use(s) of the active substance indicate a
danger for the environment then the tests described in Sections XII and XIII shall be required
3. If the result of the test in paragraph 7.6.1.2 of Annex IIA is negative and if the likely route of disposal
of the active substance is by sewage treatment then the test described in Section XIII, part 4.1 shall berequired
4. Any other biodegradability tests that are relevant from the results in paragraphs 7.6.1.1 and 7.6.1.2 of
Annex IIA
5. Phototransformation in air (estimation method), including identification of breakdown products(
1)
6. If the results from paragraphs 7.6.1.2 in Annex IIA or from paragraph 4, above, indicate the need to
do so, or the active substance has an overall low or absent abiotic degradation, then the testsdescribed in Section XII, part 1.1, part 2.1 and, where appropriate, part 3 shall be required
VIII. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
1. Identification of any substances falling within the scope of List I or List II of the Annex to Directive
80/68/EEC on the protection of groundwater against pollution caused by certain dangeroussubstances(*)
Notes
(
1) These data must be submitted for the purified active substance of stated specification.
(2) These data must be submitted for the active substance of stated specification.
XI. FURTHER HUMAN HEALTH-RELATED STUDIES
1. Food and feedingstuffs studies1.1. Identification of degradation and reaction products and of metabolites of the active substance in
treated or contaminated foods or feedstuffs
1.2. Behaviour of the residue of the active substance, its degradation products and, where relevant, its
metabolites on the treated or contaminated food or feedstuffs including the kinetics ofdisappearance
1.3. Overall material balance for the active substance. Sufficient residue data from supervised trials to
demonstrate that residues likely to arise from the proposed use would not be of concern for human oranimal health
1.4. Estimation of potential or actual exposure of the active substance to humans through diet and other
means
1.5. If residues of the active substance remain on feedingstuffs for a significant period of time then feeding
and metabolism studies in livestock shall be required to permit evaluation of residues in food ofanimal origin
1.6. Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues
of the active substance
1.7. Proposed acceptable residues and the justification of their acceptability1.8. Any other available information that is relevant
(*) OJ L 20, 26.1.1980, p. 43.EN Official Journal of the European Communities L 123/35 24.4.98
1.9. Summary and evaluation of data submitted under 1.1 to 1.8
2. Other test(s) related to the exposure to humans
Suitable test(s) and a reasoned case will be required
XII. FURTHER STUDIES ON FATE AND BEHAVIOUR IN THE ENVIRONMENT
1. Fate and behaviour in soil1.1. Rate and route of degradation including identification of the processes involved and identification of
any metabolites and degradation products in at least three soil types under appropriate conditions
1.2. Absorption and desorption in at least three soil types and, where relevant, absorption and desorption
of metabolites and degradation products
1.3. Mobility in at least three soil types and where relevant mobility of metabolites and degradation
products
1.4. Extent and nature of bound residues
2. Fate and behaviour in water
2.1. Rate and route of degradation in aquatic systems (as far as is not covered by Annex IIA,
paragraph 7.6) including identification of metabolites and degradation products
2.2. Absorption and desorption in water (soil sediment systems) and, where relevant, absorption and
desorption of metabolites and degradation products
3. Fate and behaviour in air
If the active substance is to be used in preparations for fumigants, if it is to be applied by a spray
method, if it is volatile, or if any other information indicates that this is relevant, then the rate androute of degradation in air shall be determined as far as is not covered by Section VII, part 5
4. Summary and evaluation of parts 1, 2 and 3
XIII. FURTHER ECOTOXICOLOGICAL STUDIES
1. Effects on birds1.1. Acute oral toxicity — this need not be done if an avian species was selected for study in Section VII,
part 1
1.2. Short-term toxicity — eight-day dietary study in at least one species (other than chickens)1.3. Effects on reproduction
2. Effects on aquatic organisms
2.1. Prolonged toxicity to an appropriate species of fish2.2. Effects on reproduction and growth rate on an appropriate species of fish
2.3. Bioaccumulation in an appropriate species of fish2.4. Daphnia magna reproduction and growth rateEN Official Journal of the European Communities L 123/36 24.4.98
3. Effects on other non-target organisms
3.1. Acute toxicity to honeybees and other beneficial arthropods, e.g. predators. A different test organism
shall be chosen from that used in Section VII, part 1
3.2. Toxicity to earthworms and to other soil non-target macro-organisms3.3. Effects on soil non-target micro-organisms
3.4. Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk
4. Other effects
4.1. Activated sludge respiration inhibition test
5. Summary and evaluation of parts 1, 2, 3 and 4EN Official Journal of the European Communities L 123/37 24.4.98
ANNEX IIIB
ADDITIONAL DATA SET FOR BIOCIDAL PRODUCTS
CHEMICAL PRODUCTS
1. Dossiers on biocidal products are required to address at least all the points listed under ‘Dossier
requirements’. Responses are required to be supported by data. The dossier requirements must be in linewith technical development.
2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses
need not be supplied. The same applies where it is not scientifically necessary or technically possible tosupply the information. In such cases a justification, acceptable to the competent authority must besubmitted. Such a justification may be the existence of a frame-formulation to which the applicant hasthe right of access.
3. Information may be derived from existing data where a justification acceptable to the competent
authority is provided. In particular, the provisions of Directive 88/379/EEC should be used whereverpossible to minimise animal testing.
XI. FURTHER HUMAN HEALTH-RELATED STUDIES
1. Food and feedingstuffs studies1.1. If residues of the biocidal product remain on feedingstuffs for a significant period of time, then
feeding and metabolism studies in livestock shall be required to permit evaluation of residues in foodof animal origin
1.2. Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues
of the biocidal product
2. Other test(s) related to the exposure to humans
Suitable test(s) and a reasoned case will be required for the biocidal product
XII. FURTHER STUDIES ON FATE AND BEHAVIOUR IN THE ENVIRONMENT
1. Where relevant all the information required in Annex IIIA, Section XII
2. Testing for distribution and dissipation in the following:
(a) Soil(b) Water(c) Air
Test requirements 1 and 2 above are applicable only to ecotoxicologically relevant components of
the biocidal product
XIII. FURTHER ECOTOXICOLOGICAL STUDIES
1. Effects on birds1.1. Acute oral toxicity, if not already done in accordance with Annex IIB, Section VIIEN Official Journal of the European Communities L 123/38 24.4.98
2. Effects on aquatic organisms
2.1. In case of application on, in, or near to surface waters
2.1.1. Particular studies with fish and other aquatic organisms2.1.2. Residue data in fish concerning the active substance and including toxicologically relevant
metabolites
2.1.3. The studies referred to in Annex IIIA, Section XIII, parts 2.1, 2.2, 2.3 and 2.4 may be required for
relevant components of the biocidal product
2.2. If the biocidal product is to be sprayed near to surface waters then an overspray study may be
required to assess risks to aquatic organisms under field conditions
3. Effects on other non-target organisms
3.1. Toxicity to terrestrial vertebrates other than birds3.2. Acute toxicity to honeybees3.3. Effects on beneficial arthropods other than bees3.4. Effects on earthworms and other soil non-target macro-organisms, believed to be at risk3.5. Effects on soil non-target micro-organisms3.6. Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk3.7. If the biocidal product is in the form of bait or granules
3.7.1. Supervised trials to assess risks to non-target organisms under field conditions3.7.2. Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to
be at risk
4. Summary and evaluation of parts 1, 2, and 3EN Official Journal of the European Communities L 123/39 24.4.98
ANNEX IVA
DATA SET FOR ACTIVE SUBSTANCES
FUNGI, MICRO-ORGANISMS AND VIRUSES
1. Dossiers on active organisms are required to address at least all the points listed under ‘Dossier
requirements’ below. Responses are required to be supported by data. The dossier requirements must bein line with technical development.
2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses
need not be supplied. The same applies where it is not scientifically necessary or technically possible tosupply the information. In such cases, a justification, acceptable to the competent authority must besubmitted. Such a justification may be the existence of a frame-formulation to which the applicant hasthe right of access.
Dossier requirements
I. Applicant details
II. Identity of the active organism
III. Source of active organism
IV. Methods of detection and identification
V. Biological properties of active organism including pathogenicity and infectivity for target and
non-target organisms including man
VI. Effectiveness and intended uses
VII. Toxicological profile for man and animals including metabolism of toxins
VIII. Ecotoxicological profile including environmental fate and behaviour of the organisms and of toxins it
produces
IX. Measures necessary to protect man, non-target organisms and the environment
X. Classification and labelling
XI. Summary and evaluation of Sections II to X
The following data will be required to support submissions on the above points.
I. APPLICANT
1.1. Applicant (name, address, etc.)1.2. Manufacturer (name, address, plant location)
II. IDENTITY OF THE ORGANISM
2.1. Common name of organism (including alternative and superseded names)2.2. Taxonomic name and strain indicating whether it is a stock variant or a mutant strain; for viruses,
taxonomic designation of the agent, serotype, strain or mutant
2.3. Collection and culture reference number where the culture is deposited
2.4. Methods, procedures and criteria used to establish the presence and identity of the organism (e.g.
morphology, biochemistry, serology, etc.)EN Official Journal of the European Communities L 123/40 24.4.98
III. SOURCE OF THE ORGANISM
3.1. Occurrence in nature or otherwise3.2. Isolation methods for organism or active strain3.3. Culture methods3.4. Production methods including details of containment and procedure to maintain quality and ensure
a uniform source of active organism. For mutant strains detailed information should be provided onproduction and isolation, together with all known differences between the mutant strains and parentand naturally occurring strains
3.5. Composition of the final active organism material i.e. nature, purity, identity, properties, content of
any impurities and extraneous organisms
3.6. Methods to prevent contamination of seed stock and loss of virulence of seed stock3.7. Procedures for waste management
IV. METHODS OF DETECTION AND IDENTIFICATION
4.1. Methods for establishing the presence and identity of the organism4.2. Methods for establishing the identity and purity of seed stock from which batches are produced and
results obtained, including information on variability
4.3. Methods to show the microbiological purity of the final product and showing that contaminants
have been controlled to an acceptable level, the results obtained and information on variability
4.4. Methods used to show that there are no human or other mammalian pathogens as contaminants in
the active agent, including in the case of protozoa and fungi, the effects of temperature (35°C andother relevant temperatures)
4.5. Methods to determine viable and non-viable (e.g. toxins) residues in or on treated products,
foodstuffs, feedingstuffs, animal and human body fluids and tissues, soil, water and air, whererelevant
V. BIOLOGICAL PROPERTIES OF THE ORGANISM
5.1. History of the organism and its uses including as far as is known its general natural history and, if
relevant, its geographical distribution
5.2. Relationship to existing pathogens of vertebrates, invertebrates, plants or other organisms5.3. Effects on target organism. Pathogenicity or kind of antagonism to the host. Details of host
specificity range should be included
5.4. Transmissibility, infective dose and mode of action including information on presence, absence or
production of toxins with, if appropriate, information on their nature, identity, chemical structureand stability and potency
5.5. Possible effects on non-target organisms closely related to the target organism including infectivity,
pathogenicity, and transmissibility
5.6. Transmissibility to other non-target organisms5.7. Any other biological effects on non-target organisms when properly used5.8. Infectivity and physical stability when properly usedEN Official Journal of the European Communities L 123/41 24.4.98
5.9. Genetic stability under environmental conditions of proposed use
5.10. Any pathogenicity and infectivity to man and animals under conditions of immunosuppression5.11. Pathogenicity and infectivity for known parasites/predators of the target species
VI. EFFECTIVENESS AND INTENDED USES
6.1. Harmful organisms controlled and materials, substances, organisms or products to be treated or
protected
6.2. Uses envisaged (e.g. insecticide, disinfectant, anti-fouling product, etc.)6.3. Information or observations on undesirable or unintended side effects6.4. Information on the occurrence or possible occurrence of the development of resistance and possible
management strategies to deal with this
6.5. Effects on target organisms6.6. Category of user
VII. TOXICOLOGICAL AND METABOLIC STUDIES
7.1. Acute toxicity
In cases where a single dose is not appropriate, a set of range finding tests must be carried out to
reveal highly toxic agents and infectivity
1. oral2. dermal3. inhalation4. skin and where necessary eye irritation5. skin sensitisation and, where necessary, respiratory sensitisation and6. for viruses and viroids, cell culture studies using purified infective virus and primary cell cultures
of mammalian, avian and fish cells
7.2. Sub-chronic toxicity
40-day study, two species, one rodent, one non-rodent1. oral administration2. other routes (inhalation, dermal) as appropriate and3. for viruses and viroids test for infectivity carried out by bio assay or on a suitable cell culture at
least seven days after administration to test animals
7.3. Chronic toxicity
Two species, rodent and one other mammal, oral administration unless another route is more
appropriate
7.4. Carcinogenicity study
May be combined with studies in 6.3. One rodent and one other mammal
7.5. Mutagenicity studies
As specified in Annex IIA, Section VI, part 6.6EN Official Journal of the European Communities L 123/42 24.4.98
7.6. Reproductive toxicity
Teratogenicity test — rabbit and one rodent species. Fertility study — one species, minimum of two
generations, male and female
7.7. Metabolism studies
Basic toxicokinetics, absorption (including dermal absorption) distribution and excretion in
mammals including elucidation of metabolic pathways
7.8. Neurotoxicity studies: required where there is any indication of anticholinerterase activity or other
neurotoxic effects. Delayed neurotoxicity tests using adult hens should be performed whereappropriate
7.9. Immunotoxicity studies (e.g. allergenicity)7.10. Incidental exposure studies: required where the active substance will be in products for use where
human food or animal feedingstuffs are prepared, consumed or stored and where humans, livestockor pets are likely to be exposed to treated areas or materials
7.11. Human exposure data including:
1. Medical data in anonymous form (if available)2. Health records, medical surveillance data on manufacturing plants personnel (if available)3. Epidemiological data (if available)4. Poisoning incidents data5. Poisoning diagnosis (signs, symptoms) including details of any analytical tests6. Proposed treatment of poisoning and prognoses
7.12. Summary of mammalian toxicology — conclusions (including NOAEL, NOEL and if appropriate
ADI), overall evaluation with regard to all toxicological, pathogenicity and infectivity data and anyother information concerning the active organism. Where possible suggested user protectionmeasures should be included in summary form
VIII. ECOTOXICOLOGICAL STUDIES
8.1. Acute toxicity to fish8.2. Acute toxicity to Daphnia magna
8.3. Effects on algae growth (inhibition test)8.4. Acute toxicity on one other, non-aquatic, non-target organism8.5. Pathogenicity and infectivity for honeybees and earthworms8.6. Acute toxicity and/or pathogenicity and infectivity for other non-target organisms believed to be at
risk
8.7. Effects (if any) on other flora and fauna
8.8. In cases where toxins are produced, data as outlined in Annex IIA, Section VII, parts 7.1 to 7.5
should be produced
Fate and behaviour in the environment
8.9. Spread, mobility, multiplication and persistence in air, soil and water8.10. In cases where toxins are produced, data as outlined in Annex IIA, Section VII, parts 7.6 to 7.8EN Official Journal of the European Communities L 123/43 24.4.98
IX. MEASURES NECESSARY TO PROTECT HUMANS, NON-TARGET ORGANISMS AND THE
ENVIRONMENT
9.1. Methods and precautions to be taken for storage, handling, transport and use; or in the event of fire
or other likely incident
9.2. Any circumstances or environmental conditions under which the active organism should not be
used
9.3. The possibility of rendering the active organism non-infective and any method for doing this9.4. Consequences of the contamination of air, soil and water, particularly drinking water9.5. Emergency measures in case of accident9.6. Procedures for waste management of the active organism including leachate qualities on disposal9.7. Possibility of destruction or decontamination following release in or into the following: air, water,
soil, others if appropriate
X. CLASSIFICATION AND LABELLING
Proposals for allocation to one of the risk groups outlined in Article 2(d) of Directive 90/679/EEC
with justifications for the proposal together with indications on the need for products to carry thebiohazard sign specified in Annex II to Directive 90/679/EEC
XI. SUMMARY AND EVALUATION OF SECTIONS II TO XEN Official Journal of the European Communities L 123/44 24.4.98
ANNEX IVB
DATA SET FOR BIOCIDAL PRODUCTS
FUNGI, MICRO-ORGANISMS AND VIRUSES
1. Dossiers on biocidal products are required to address at least all the points listed under ‘Dossier
requirements’. Responses are required to be supported by data. The dossier requirements must be in linewith technical development.
2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses
need not be supplied. The same applies where it is not scientifically necessary or technically possible tosupply the information. In such cases, a justification, acceptable to the competent authority must besubmitted. Such a justification may be the existence of a frame-formulation to which the applicant hasthe right of access.
3. Information may be derived from existing data where a justification acceptable to the competent
authority is provided. In particular, the provisions of Directive 88/379/EEC should be used whereverpossible to minimise animal testing.
Dossier requirements
I. Applicant
II. Identity and composition of the biocidal product
III. Technical properties of the biocidal product and any biocidal properties additional to those of the
active organism
IV. Methods for identification and analysis of the biocidal product
V. Intended uses and efficacy for those uses
VI. Toxicological information (additional to that for the active organism)
VII. Ecotoxicological information (additional to that for the active organism)
VIII. Measures to be adopted to protect humans, non-target organisms and the environment
IX. Classification, packaging and labelling of the biocidal product
X. Summary of Sections II to IX
The following data will be required to support submission on the above points.
I. APPLICANT
1.1. Name and address, etc.1.2. Manufacturers of biocidal products and active organisms including location of plants
II. IDENTITY OF BIOCIDAL PRODUCT
2.1. Trade name or proposed trade name and manufacturer’s development code number for biocidal
product, if appropriate
2.2. Detailed quantitative and qualitative information on the composition of the biocidal product (active
organisms, inert components, extraneous organisms, etc.)EN Official Journal of the European Communities L 123/45 24.4.98
2.3. Physical state and nature of the biocidal product (emulsifiable concentrate, wettable powder, etc.)
2.4. Concentration of active organism in material used
III. TECHNICAL AND BIOLOGICAL PROPERTIES
3.1. Appearance (colour and odour)3.2. Storage — stability and shelf-life. Effects of temperature, method of packaging and storage, etc. on
retention of biological activity
3.3. Methods for establishing storage and shelf-life stability3.4. Technical characteristics of the biocidal product
3.4.1. Wettability3.4.2. Persistent foaming3.4.3. Suspensibility and suspension stability3.4.4. Wet sieve test and dry sieve test3.4.5. Particle size distribution, content of dust/fines, attrition and friability3.4.6. In the case of granules, sieve test and indications of weight distribution of the granules, at least of
the fraction with particle sizes bigger than 1 mm
3.4.7. Content of active substance in or on bait particles, granules or treated material3.4.8. Emulsifiability, re-emulsifiability, emulsion stability3.4.9. Flowability, pourability and dustability
3.5. Physical and chemical compatibility with other products including biocidal products with which its
use is to be authorised
3.6. Wetting, adherence and distribution following application3.7. Any changes to biological properties of the organism is a result of formulation. In particular changes
in pathogenicity on infectivity
IV. METHOD FOR IDENTIFICATION AND ANALYSIS
4.1. Analytical methods for determining the composition of the biocidal product4.2. Methods for determining residues (e.g. biotest)4.3. Methods used to show microbiological purity of the biocidal product4.4. Methods used to show the biocidal product to be free from any human and other mammalian
pathogens or, if need be, from pathogens harmful to non-target organisms and the environment
4.5. Techniques used to ensure a uniform product and assay methods for its standardisation
V. INTENDED USES AND EFFICACY FOR THESE USES
5.1. Use
Product-type (e.g. wood preservative, insecticide, etc.)
5.2. Details of intended use, (e.g. types of harmful organism controlled, materials to be treated, etc.)EN Official Journal of the European Communities L 123/46 24.4.98
5.3. Application rate
5.4. Where necessary, in the light of the test results, any specific circumstances or environmental
conditions under which the product may or may not be used
5.5. Method of application5.6. Number and timing of applications5.7. Proposed instructions for use
Efficacy data
5.8. Preliminary range-finding tests5.9. Field experimentation5.10. Information on the possible occurrence of the development of resistance5.11. Effects on the quality of materials or products treated
VI. TOXICITY INFORMATION ADDITIONAL TO THAT REQUIRED FOR THE ACTIVE
ORGANISM
6.1. Oral single dose6.2. Percutaneous single dose6.3. Inhalation6.4. Skin and where relevant eye irritation6.5. Skin sensitisation6.6. Available toxicological data relating to non-active substances6.7. Operator exposure
6.7.1. Percutaneous absorption/inhalation depending on formulation and method of application6.7.2. Likely operator exposure under field conditions, including where relevant quantitative analysis of
operator exposure
VII. ECOTOXICITY INFORMATION ADDITIONAL TO THAT REQUIRED FOR THE ACTIVE
ORGANISM
7.1. Observations concerning undesirable or unintended side-effects, e.g. on beneficial and other
non-target organisms or persistence in the environment
VIII. MEASURES TO BE ADOPTED TO PROTECT MAN, NON-TARGET ORGANISMS AND THE
ENVIRONMENT
8.1. Recommended methods and precautions concerning handling, storage, transport and use8.2. Re-entry periods, necessary waiting periods or other precautions to protect humans and animals8.3. Emergency measures in case of an accident8.4. Procedures for destruction or decontamination of the biocidal product and its packagingEN Official Journal of the European Communities L 123/47 24.4.98
IX. CLASSIFICATION, PACKAGING AND LABELLING
9.1. Proposals including justification for the classification, packaging and labelling
I. With regard to non-biological components of the product in accordance with Directive
88/379/EEC
— Hazard symbol(s)— Indications of danger— Risk phrases— Safety phrases
II. With regard to the active organisms labelling with the appropriate risk group as outlined in
Article 2(d) of Directive 90/679/EEC together with the biohazard sign specified in that Directiveif appropriate
9.2. Packaging (type, materials, size, etc.), compatibility of the biocidal product with proposed packaging
materials
9.3. Specimens of proposed packaging
X. SUMMARY OF SECTIONS II to IXEN Official Journal of the European Communities L 123/48 24.4.98
ANNEX V
BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)(a)
OF THIS DIRECTIVE
These product-types exclude products where they are covered by the Directives mentioned in Article 1(2) of
this Directive for the purposes of these Directives and their subsequent modifications.
MAIN GROUP 1: Disinfectants and general biocidal products
These product types exclude cleaning products that are not intended to have a biocidal effect, including
washing liquids, powders and similar products.
Product-type 1: Human hygiene biocidal products
Products in this group are biocidal products used for human hygiene purposes.
Product-type 2: Private area and public health area disinfectants and other biocidal products
Products used for the disinfection of air, surfaces, materials, equipment and furniture which are not used for
direct food or feed contact in private, public and industrial areas, including hospitals, as well as productsused as algaecides.
Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air-conditioning
systems; walls and floors in health and other institutions; chemical toilets, waste water, hospital waste, soilor other substrates (in playgrounds).
Product-type 3: Veterinary hygiene biocidal products
Products in this group are biocidal products used for veterinary hygiene purposes including products used in
areas in which animals are housed, kept or transported.
Product-type 4: Food and feed area disinfectants
Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework
associated with the production, transport, storage or consumption of food, feed or drink (including drinkingwater) for humans and animals.
Product-type 5: Drinking water disinfectants
Products used for the disinfection of drinking water (for both humans and animals).
MAIN GROUP 2: Preservatives
Product-type 6: In-can preservatives
Products used for the preservation of manufactured products, other than foodstuffs or feedingstuffs, in
containers by the control of microbial deterioration to ensure their shelf life.
Product-type 7: Film preservatives
Products used for the preservation of films or coatings by the control of microbial deterioration in order to
protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, walladhesives, binders, papers, art works.EN Official Journal of the European Communities L 123/49 24.4.98
Product-type 8: Wood preservatives
Products used for the preservation of wood, from and including the saw-mill stage, or wood products by
the control of wood-destroying or wood-disfiguring organisms.
This product type includes both preventive and curative products.
Product-type 9: Fibre, leather, rubber and polymerised materials preservatives
Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or
textile products and rubber by the control of microbiological deterioration.
Product-type 10: Masonry preservatives
Products used for preservation and remedial treatment of masonry or other construction materials other
than wood by the control of microbiological and algal attack.
Product-type 11: Preservatives for liquid-cooling and processing systems
Products used for the preservation of water or other liquids used in cooling and processing systems by the
control of harmful organisms such as microbes, algae and mussels.
Products used for the preservation of drinking water are not included in this product type.
Product-type 12: Slimicides
Products used for the prevention or control of slime growth on materials, equipment and structures, used in
industrial processes, e.g. on wood and paper pulp, porous sand strata in oil extraction.
Product-type 13: Metalworking-fluid preservatives
Products used for the preservation of metalworking fluids by the control of microbial deterioration.
MAIN GROUP 3: Pest control
Product-type 14: Rodenticides
Products used for the control of mice, rats or other rodents.
Product-type 15: Avicides
Products used for the control of birds.
Product-type 16: Molluscicides
Products used for the control of molluscs.
Product-type 17: Piscicides
Products used for the control of fish; these products exclude products for the treatment of fish diseases.
Product-type 18: Insecticides, acaricides and products to control other arthropods
Products used for the control of arthropods (e.g. insects, arachnids and crustaceans).
Product-type 19: Repellents and attractants
Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds), by
repelling or attracting, including those that are used for human or veterinary hygiene either directly orindirectly.EN Official Journal of the European Communities L 123/50 24.4.98
MAIN GROUP 4: Other biocidal products
Product-type 20: Preservatives for food or feedstocks
Products used for the preservation of food or feedstocks by the control of harmful organisms.
Product-type 21: Antifouling products
Products used to control the growth and settlement of fouling organisms (microbes and higher forms of
plant or animal species) on vessels, aquaculture equipment or other structures used in water.
Product-type 22: Embalming and taxidermist fluids
Products used for the disinfection and preservation of human or animal corpses, or parts thereof.
Product-type 23: Control of other vertebrates
Products used for the control of vermin.EN Official Journal of the European Communities L 123/51 24.4.98
ANNEX VI
COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS
CONTENTS
DefinitionsIntroductionEvaluation
— General principles— Effects on humans— Effects on animals— Effects on the environment— Unacceptable effects— Efficacy— Summary
Decision-making
— General principles— Effects on humans— Effects on animals— Effects on the environment— Unacceptable effects— Efficacy— Summary
Overall integration of conclusions
DEFINITIONS
(a)Hazard identification
This is the identification of the adverse effects which a biocidal product has an inherent capacity to
cause.
(b)Dose (concentration) — response (effect) assessment
This is the estimate of the relationship between the dose, or level of exposure, of an active substance or
substance of concern in a biocidal product and the incidence and severity of an effect.
(c)Exposure assessment
This is the determination of the emissions, pathways and rates of movement of an active substance or a
substance of concern in a biocidal product and its transformation or degradation in order to estimatethe concentration/doses to which human populations, animals or environmental compartments are ormay be exposed.
(d)Risk characterisation
This is the estimation of the incidence and severity of the adverse effects likely to occur in a human
population, animals or environmental compartments due to actual or predicted exposure to any activesubstance or substance of concern in a biocidal product. This may include ‘risk estimation’ i.e. thequantification of that likelihood.
(e)Environment
Water, including sediment, air, land, wild species of fauna and flora, and any interrelationship between
them, as well as any relationship with living organisms.EN Official Journal of the European Communities L 123/52 24.4.98
INTRODUCTION
1. This Annex lays down principles to ensure that evaluations made and decisions taken by a Member
State concerning the authorisation of a biocidal product providing it is a chemical preparation resultsin a harmonised high level of protection for humans, animals and the environment in accordance withArticle 5(1)(b) of this Directive.
2. In order to ensure a high and harmonised level of protection of human and animal health and of the
environment, any risks arising from the use of a biocidal product shall be identified. To achieve this arisk assessment shall be carried out to determine the acceptability or otherwise of any risks identifiedduring the proposed normal use of the biocidal product. This is done by carrying out an assessment ofthe risks associated with the relevant individual components of the biocidal product.
3. A risk assessment on the active substance or substances present in the biocidal product is always
required. This will already have been carried out for the purpose of Annexes I, IA or IB. This riskassessment shall entail hazard identification, and, as appropriate, dose (concentration) — response(effect) assessment, exposure assessment and risk characterisation. Where a quantitative risk assessmentcannot be made a qualitative assessment shall be produced.
4. Additional risk assessments shall be carried out, in the same manner as described above, on any other
substance of concern present in the biocidal product where relevant for the use of the biocidalproduct.
5. In order to carry out a risk assessment data are required. These data are detailed in Annexes II, III and
IV and, recognising that there are a wide variety of product types, are flexible according to the producttype and associated risks. The data required shall be the minimum necessary to carry out anappropriate risk assessment. Member States should take due consideration of the requirements ofArticles 12 and 13 of this Directive in order to avoid duplication of data submissions. The minimumset of data required for an active substance in any biocidal product type, however, shall be thatdetailed in Annex VIIA to Directive 67/548/EEC; these data will already have been submitted andassessed as part of the risk assessment required for entry of the active substance into Annex I, IA or IBto this Directive. Data may also be required on a substance of concern present in a biocidalproduct.
6. The results of the risk assessments carried out on an active substance and on a substance of concern
present in the biocidal product shall be integrated to produce an overall assessment for the biocidalproduct itself.
7. When making evaluations and taking decisions concerning the authorisation of a biocidal product the
Member State shall:
(a) take into consideration other relevant technical or scientific information which is reasonably
available to them with regard to the properties of the biocidal product, its components,metabolites, or residues;
(b) evaluate, where relevant, justifications submitted by the applicant for not supplying certain data.
8. The Member State shall comply with the requirements of mutual recognition as stated in Articles 4(1),
(2) and (6) of this Directive.
9. It is known that many biocidal products present only minor differences in composition and this should
be taken into account when evaluating dossiers. The concept of ‘frame-formulations’ is relevant here.
10. It is known that certain biocidal products are considered as posing only a low risk, these biocidal
products, while complying with the requirements of this Annex, are subject to a simplified procedureas detailed in Article 3 of this Directive.
11. The application of these common principles shall lead to the Member State deciding whether or not a
biocidal product can be authorised, such authorisation may include restrictions on use or otherconditions. In certain cases the Member State may conclude that more data are required before anauthorisation decision can be made.EN Official Journal of the European Communities L 123/53 24.4.98
12. During the process of evaluation and decision-making, Member States and applicants shall cooperate in
order to resolve any questions on the data requirements quickly or to identify at an early stage anyadditional studies required, or to amend any proposed conditions for the use of the biocidal product orto modify its nature or its composition in order to ensure full compliance with the requirements of thisAnnex or of this Directive. The administrative burden, especially for small and medium-sizedenterprises (SMEs), shall be kept to the minimum necessary without prejudicing the level of protectionafforded to humans, animals and the environment.
13. The judgments made by the Member State during the evaluation and decision-making process must be
based on scientific principles, preferably recognised at international level, and be made with the benefitof expert advice.
EVALUATION
General principles14. The data submitted in support of an application for authorisation of a biocidal product shall be
examined for completeness and overall scientific value by the receiving Member State. After acceptanceof these data the Member State shall utilise them by carrying out a risk assessment based on theproposed use of the biocidal product.
15. A risk assessment on the active substance present in the biocidal product shall always be carried out. If
there are, in addition, any substances of concern present in the biocidal product then a risk assessmentshall be carried out for each of these. The risk assessment shall cover the proposed normal use of thebiocidal product together with a realistic worst-case scenario including any relevant production anddisposal issue either of the biocidal product itself or any material treated with it.
16. For each active substance and each substance of concern present in the biocidal product, the risk
assessment shall entail a hazard identification and the establishment of appropriateno-observed-adverse-effect levels (NOAEL), where possible. It shall also include, as appropriate, a dose(concentration) — response (effect) assessment, together with an exposure assessment and a riskcharacterisation.
17. The results arrived at from a comparison of the exposure to the no-effect level concentrations for each
of the active substances and any substances of concern shall be integrated to produce an overall riskassessment for the biocidal product. Where quantitative results are not available the results of thequalitative assessments shall be integrated in a similar manner.
18. The risk assessment shall determine:
(a) the risk to humans and animals,(b) the risk to the environment,(c) the measures necessary to protect humans, animals and the general environment during both the
proposed normal use of the biocidal product and in a realistic worst-case situation.
19. In certain cases it may be concluded that further data are required before a risk assessment can be
finalised. Any such additional data requested shall be the minimum necessary to complete such a riskassessment.
Effects on humans
20. The risk assessment shall take account of the following potential effects arising from the use of the
biocidal product and the populations liable to exposure.
21. The effects previously mentioned result from the properties of the active substance and any substance
of concern present. They are:
— acute and chronic toxicity,— irritation,
— corrosivity,— sensitisation,— repeated dose toxicity,EN Official Journal of the European Communities L 123/54 24.4.98
— mutagenicity,
— carcinogenicity,
— reproduction toxicity,— neurotoxicity,— any other special properties of the active substance or substance of concern,— other effects due to physico-chemical properties.
22. The populations previously mentioned are:
— professional users,— non-professional users,— humans exposed indirectly via the environment.
23. The hazard identification shall address the properties and potential adverse effects of the active
substance and any substances of concern present in the biocidal product. If this results in the biocidalproduct being classified according to the requirements of Article 20 of this Directive then dose(concentration) — response (effect) assessment, exposure assessment and risk characterisation shall berequired.
24. In those cases where the test appropriate to hazard identification in relation to a particular potential
effect of an active substance or a substance of concern present in a biocidal product has beenconducted but the results have not lead to classification of the biocidal product then riskcharacterisation in relation to that effect shall not be necessary unless there are other reasonablegrounds for concern, e.g. adverse environmental effects or unacceptable residues.
25. The Member State shall apply paragraphs 26 to 29 when carrying out a dose (concentration) —
response (effect) assessment on an active substance or a substance of concern present in a biocidalproduct.
26. For repeated dose toxicity and reproductive toxicity the dose response relationship shall be assessed for
each active substance or substance of concern and, where possible, the no-observed-adverse-effect level(NOAEL) identified. If it is not possible to identify a NOAEL, the lowest-observed-adverse-effect level(LOAEL) shall be identified.
27. For acute toxicity, corrosivity and irritation, it is not usually possible to derive a NOAEL or LOAEL
on the basis of tests conducted in accordance with the requirements of this Directive. For acutetoxicity, the LD50 (median lethal dose) or LC50 (median lethal concentration) value or, where thefixed dose procedure has been used, the discriminating dose shall be derived. For the other effects itshall be sufficient to determine whether the active substance or substance of concern has an inherentcapacity to cause such effects during use of the product.
28. For mutagenicity and carcinogenicity it shall be sufficient to determine whether the active substance or
substance of concern has an inherent capacity to cause such effects during use of the biocidal product.However, if it can be demonstrated that an active substance or a substance of concern identified as acarcinogen is non-genotoxic, it will be appropriate to identify a N(L)OAEL as described inparagraph 26.
29. With respect to skin sensitisation and respiratory sensitisation, in so far as there is no consensus on the
possibility of identifying a dose/concentration below which adverse effects are unlikely to occur in asubject already sensitised to a given substance, it shall be sufficient to evaluate whether the activesubstance or substance of concern has an inherent capacity to cause such effects during use of thebiocidal product.
30. Where toxicity data derived from observations of human exposure, e.g. information gained from
manufacture, from poison centres or epidemiology surveys, are available special consideration shall begiven to those data when carrying out the risk assessment.
31. An exposure assessment shall be carried out for each of the human populations (professional users,
non-professional users and humans exposed indirectly via the environment) for which exposure to abiocidal product occurs or can reasonably be foreseen. The objective of the assessment shall be to makeEN Official Journal of the European Communities L 123/55 24.4.98
a quantitative or qualitative estimate of the dose/concentration of each active substance or substance of
concern to which a population is, or may be exposed during use of the biocidal product.
32. The exposure assessment shall be based on the information in the technical dossier provided in
conformity with Article 8 of this Directive and on any other available and relevant information.Particular account shall be taken, as appropriate, of:
— adequately measured exposure data,— the form in which the product is marketed,— the type of biocidal product,— the application method and application rate,— the physico-chemical properties of the product,— the likely routes of exposure and potential for absorption,— the frequency and duration of exposure,— the type and size of specific exposed populations where such information is available.
33. Where adequately measured, representative exposure data are available, special consideration shall be
given to them when conducting the exposure assessment. Where calculation methods are used for theestimation of exposure levels, adequate models shall be applied.
These models shall:— make a best possible estimation of all relevant processes taking into account realistic parameters
and assumptions,
— be subjected to an analysis taking into account possible elements of uncertainty,— be reliably validated with measurements carried out under circumstances relevant for the use of the
model,
— be relevant to the conditions in the area of use.Relevant monitoring data from substances with analogous use and exposure patterns or analogous
properties shall also be considered.
34. Where, for any of the effects set out in paragraph 21 a NOAEL or LOAEL had been identified, the
risk characterisation shall entail comparison of the NOAEL or LOAEL with the evaluation of thedose/concentration to which the population will be exposed. Where a NOAEL or LOAEL cannot beestablished a qualitative comparison shall be made.
Effects on animals
35. Using the same relevant principles as described in the section dealing with effects on humans, the
Member State shall consider the risks posed to animals from the biocidal product.
Effects on the environment
36. The risk assessment shall take account of any adverse effects arising in any of the three environmental
compartments — air, soil and water (including sediment) — and of the biota following the use of thebiocidal product.
37. The hazard identification shall address the properties and potential adverse effects of the active
substance and any substances of concern present in the biocidal product. If this results in the biocidalproduct being classified according to the requirements of this Directive then dose (concentration) —response (effect) assessment, exposure assessment and risk characterisation shall be required.
38. In those cases where the test appropriate to hazard identification in relation to a particular potential
effect of an active substance or a substance of concern present in a biocidal product has beenconducted but the results have not led to classification of the biocidal product then riskEN Official Journal of the European Communities L 123/56 24.4.98
characterisation in relation to that effect shall not be necessary unless there are other reasonable
grounds for concern. Such grounds may derive from the properties and effects of any active substanceor substance of concern in the biocidal product, in particular:
— any indications of bioaccumulation potential,— the persistence characteristics,— the shape of the toxicity/time curve in ecotoxicity testing,— indications of other adverse effects on the basis of toxicity studies (e.g. classification as a
mutagen),
— data on structurally analogous substances,— endocrine effects.
39. A dose (concentration) — response (effect) assessment shall be carried out in order to predict the
concentration below which adverse effects in the environmental compartment of concern are notexpected to occur. This shall be carried out for the active substance and for any substance of concernpresent in the biocidal product. This concentration is known as the predicted no-effect concentration(PNEC). However, in some cases, it may not be possible to establish a PNEC and a qualitativeestimation of the dose (concentration) — response (effect) then has to be made.
40. The PNEC shall be determined from the data on effects on organisms and ecotoxicity studies submitted
in accordance with requirements of Article 8 of this Directive. It shall be calculated by applying anassessment factor to the values resulting from tests on organisms, e.g. LD50 (median lethal dose),LC50 (median lethal concentration), EC50 (median effective concentration), IC50 (concentrationcausing 50% inhibition of a given parameter, e.g. growth), NOEL(C) (no-observed-effect level(concentration)), or LOEL(C) (lowest-observed-effect level (concentration)).
41. An assessment factor is an expression of the degree of uncertainty in extrapolation from test data on a
limited number of species to the real environment. Therefore, in general, the more extensive the dataand the longer the duration of the tests, the smaller is the degree of uncertainty and the size of theassessment factor.
The specifications for the assessment factors shall be elaborated in the notes for technical guidance
which, to this end, shall be based particularly on the indications given in Commission Directive93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and environmentfrom substances notified in accordance with Council Directive 67/548/EEC(*).
42. For each environmental compartment an exposure assessment shall be carried out in order to predict
the concentration likely to be found of each active substance or substance of concern present in thebiocidal product. This concentration is known as the predicted environmental concentration (PEC).However in some cases it may not be possible to establish a PEC and a qualitative estimate of exposurethen has to be made.
43. A PEC, or where necessary a qualitative estimate of exposure, need only be determined for the
environmental compartments to which emissions, discharges, disposal or distributions including anyrelevant contribution from material treated with biocidal products are known or are reasonablyforeseeable.
44. The PEC, or qualitative estimation of exposure, shall be determined taking account of, in particular,
and if appropriate:
— adequately measured exposure data,— the form in which the product is marketed,— the type of biocidal product,— the application method and application rate,
— the physico-chemical properties,
(*) OJ L 227, 8.9.1993, p. 9.EN Official Journal of the European Communities L 123/57 24.4.98
— breakdown/transformation products,
— likely pathways to environmental compartments and potential for adsorption/desorption and
degradation,
— the frequency and duration of exposure.
45. Where adequately measured, representative exposure data are available, special consideration shall be
given to them when conducting the exposure assessment. Where calculation methods are used for theestimation of exposure levels, adequate models shall be applied. The characteristics of these modelsshall be as listed in paragraph 33. Where appropriate, on a case-by-case basis, relevant monitoring datafrom substances with analogous use and exposure patterns or analogous properties should also beconsidered.
46. For any given environmental compartment, the risk characterisation shall, as far as possible, entail
comparison of the PEC with the PNEC so that a PEC/PNEC ratio may be derived.
47. If it has not been possible to derive a PEC/PNEC ratio, the risk characterisation shall entail a
qualitative evaluation of the likelihood that an effect is occurring under the current conditions ofexposure or will occur under the expected conditions of exposure.
Unacceptable effects
48. Data shall be submitted to and evaluated by the Member State to assess whether the biocidal product
does not cause unnecessary suffering in its effect on target vertebrates. This shall include an evaluationof the mechanism by which the effect is obtained and the observed effects on the behaviour and healthof the target vertebrates; where the intended effect is to kill the target vertebrate the time necessary toobtain the death of the target vertebrate and the conditions under which death occurs shall beevaluated.
49. The Member State shall, where relevant, evaluate the possibility of the development of resistance to an
active substance in the biocidal product by the target organism.
50. If there are indications that any other unacceptable effects may occur the Member State shall evaluate
the possibility of such effects occurring. An example of such an unacceptable effect would be anadverse reaction to fastenings and fittings used in wood following the application of a woodpreservative.
Efficacy
51. Data shall be submitted and evaluated to ascertain if the efficacy claims of the biocidal product can be
substantiated. Data submitted by the applicant or held by the Member State must be able todemonstrate the efficacy of the biocidal product against the target organism when used normally inaccordance with the conditions of authorisation.
52. Testing should be carried out according to Community guidelines if these are available and applicable.
Where appropriate, other methods can be used as shown in the list below. If relevant acceptable fielddata exist, these can be used.
— ISO, CEN or other international standard method— national standard method— industry standard method (accepted by Member State)— individual producer standard method (accepted by Member State)— data from the actual development of the biocidal product (accepted by Member State).
Summary
53. In each of the areas where risk assessments have been carried out, i.e. effects on man, animals, and the
environment, the Member State shall combine the results for the active substance together with theresults for any substance of concern to produce an overall assessment for the biocidal product itself.This should take account of any likely synergistic effects of the active substance(s) and substances ofconcern in the biocidal product.
54. For biocidal products containing more than one active substance any adverse effects shall also be
combined to produce an overall effect for the biocidal product itself.EN Official Journal of the European Communities L 123/58 24.4.98
DECISION MAKING
General principles55. Subject to paragraph 96, the Member State shall come to a decision regarding the authorisation for use
of a biocidal product as a result of the integration of the risks arising from each active substancetogether with the risks from each substance of concern present in the biocidal product. The riskassessments shall cover normal use of the biocidal product together with a realistic worst-case scenarioincluding any relevant disposal issue either of the biocidal product itself or any material treated withit.
56. In making a decision concerning authorisation, the Member State shall arrive at one of the following
conclusions for each product type and for each area of use of the biocidal product for whichapplication has been made:
1. the biocidal product cannot be authorised;2. the biocidal product can be authorised subject to specific conditions/restrictions;3. more data is required before a decision on authorisation can be made.
57. If the conclusion arrived at by the Member State is that additional information or data are required
before an authorisation decision can be made, then the need for any such information or data shall bejustified. This additional information or data shall be the minimum necessary to carry out a furtherappropriate risk assessment.
58. The Member State shall comply with the principles of mutual recognition as detailed in Article 4 of
this Directive.
59. The Member State shall apply the rules concerning the concept of ‘frame formulations’ when making
an authorisation decision on a biocidal product.
60. The Member State shall apply the rules concerning the concept of ‘low risk’ products when making an
authorisation decision on such a biocidal product.
61. The Member State shall only grant authorisation to those biocidal products which, when used
according to their conditions of authorisation, do not present an unacceptable risk to humans, animalsor the environment, are efficacious and which contain active substances permitted at Community levelto be used in such biocidal products.
62. The Member State shall impose, where appropriate, conditions or restrictions when giving
authorisations. The nature and severity of these shall be selected on the basis of, and be appropriate to,the nature and extent of the expected advantages and the risks likely to arise from the use of thebiocidal product.
63. In the decision-making process the Member State shall take into consideration the following:
— the results of the risk assessment, in particular the relationship between exposure and effect,— the nature and severity of the effect,— the risk management which can be applied,— the field of use of the biocidal product,— the efficacy of the biocidal product,— the physical properties of the biocidal product,— the benefits of using the biocidal product.
64. The Member State shall, when taking a decision concerning the authorisation of a biocidal product,
take into account the uncertainty arising from the variability in the data used in the evaluation anddecision-making process.
65. The Member State shall prescribe that biocidal products shall be used properly. Proper use shall
include application at an efficacious dose and minimisation of use of biocidal products wherepossible.EN Official Journal of the European Communities L 123/59 24.4.98
66. The Member State shall take the necessary measures to ensure that the applicant proposes a label, and,
where relevant, the safety-data sheet, for the biocidal product which:
— fulfils the requirements of Articles 20 and 21 of this Directive,— contains the information on the protection of users required by Community legislation on worker
protection,
— specifies in particular the conditions or restrictions under which the biocidal product may or may
not be used.
Before issuing an authorisation the Member State shall confirm that these requirements must be
satisfied.
67. The Member State shall take the necessary measures to ensure that the applicant proposes packaging
and, where appropriate, the procedures for destruction or decontamination of the biocidal product andits packaging or any other relevant material associated with the biocidal product, which conforms tothe relevant regulatory provisions.
Effects on humans
68. The Member State shall not authorise a biocidal product if the risk assessment confirms that, in
foreseeable application including a realistic worst possible scenario, the product presents anunacceptable risk to humans.
69. The Member State shall consider possible effects on all human populations, namely professional users,
non-professional users and humans exposed directly or indirectly through the environment whenmaking a decision on the authorisation of a biocidal product.
70. The Member State shall examine the relationship between the exposure and the effect, and use this in
the decision-making process. A number of factors need to be considered when examining thisrelationship and one of the most important is the nature of the adverse effect of the substance. Theseeffects include acute toxicity, irritancy, corrosivity, sensitisation, repeated dose toxicity, mutagenicity,carcinogenicity, neurotoxicity, reproduction toxicity together with physico-chemical properties, and anyother adverse properties of the active substance or substance of concern.
71. The Member State shall, where possible, compare the results obtained with those obtained from
previous risk assessments for an identical or similar adverse effect and decide on an appropriate marginof safety (MOS) when making an authorisation decision.
An appropriate MOS is typically 100 but an MOS higher or lower than this may be appropriate
depending on, among other things, the nature of the critical toxicological effect.
72. The Member State shall, if appropriate, impose, as a condition of authorisation, the wearing of
personal protective equipment such as respirators, breathing-masks, overalls, gloves and goggles inorder to reduce exposure for professional operators. Such equipment must be readily available tothem.
73. If for non-professional users the wearing of personal protective equipment would be the only possible
method for reducing exposure, the product shall not normally be authorised.
74. If the relationship between the exposure and the effect cannot be reduced to an acceptable level then
no authorisation can be given by the Member State for the biocidal product.
75. No biocidal product classified according to Article 20(1) of this Directive as toxic, very toxic or as a
category 1 or 2 carcinogen, or as a category 1 or 2 mutagen, or classified as toxic for reproductioncategory 1 or 2, shall be authorised for use by the general public.
Effects on animals
76. The Member State shall not authorise a biocidal product if the risk assessment confirms that, in normal
use, the biocidal product presents an unacceptable risk to non-target animals.
77. Using the same relevant criteria as described in the section dealing with effects on humans, the Member
State shall consider the risks posed to animals from the biocidal product when making an authorisationdecision.EN Official Journal of the European Communities L 123/60 24.4.98
Effects on the environment
78. The Member State shall not authorise a biocidal product if the risk assessment confirms that the active
substance, or any substance of concern, or any degradation, or reaction product presents anunacceptable risk in any of the environmental compartments, water (including sediment), soil and air.This shall include the assessment of risks to non-target organisms in these compartments.
In considering whether there is an unacceptable risk Member States shall, when coming to a final
decision in accordance with paragraph 96, take into account the criteria in paragraphs 81 to 91.
79. The basic tool used in the decision making is the PEC/PNEC ratio or, if this is not available, a
qualitative estimation. Due consideration shall be given to the accuracy of this ratio due to variabilityin the data used both in measurements of concentration and of estimation.
In the determination of the PEC the most appropriate model should be used taking into account the
environmental fate and behaviour of the biocidal product.
80. For any given environmental compartment if the PEC/PNEC ratio is equal to or less than 1 the risk
characterisation shall be that no further information and/or testing are necessary.
If the PEC/PNEC ratio is greater than 1 the Member State shall judge, on the basis of the size of that
ratio and on other relevant factors, if further information and/or testing are required to clarify theconcern or if risk reduction measures are necessary or if the product cannot be given an authorisationat all. Relevant factors to be considered are those previously mentioned in paragraph 38.
Water
81. The Member State shall not authorise a biocidal product, if under the proposed conditions of use, the
foreseeable concentration of the active substance or of any other substance of concern or of relevantmetabolites or breakdown or reaction products in water (or its sediments) has an unacceptable impacton non-target species in the aquatic, marine or estuarine environment unless it is scientificallydemonstrated that under relevant field conditions there is no unacceptable effect.
82. The Member State shall not authorise a biocidal product if, under the proposed conditions of use, the
foreseeable concentration of the active substance or of any other substance of concern or of relevantmetabolites or breakdown or reaction products in groundwater exceeds the lower of the followingconcentrations:
(a) the maximum permissible concentration laid down by Directive 80/778/EEC, or(b) the maximum concentration as laid down following the procedure for including the active
substance in Annex I, IA or IB to this Directive, on the basis of appropriate data, in particulartoxicological data
unless it is scientifically demonstrated that under relevant field conditions the lower concentration is
not exceeded.
83. The Member State shall not authorise a biocidal product if the foreseeable concentration of the active
substance or a substance of concern or of relevant metabolites, breakdown or reaction products to beexpected in surface water or its sediments after use of the biocidal product under the proposedconditions of use:
— exceeds, where the surface water in or from the area of envisaged use is intended for the
abstraction of drinking water, the values fixed by
— 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(
1),
— Directive 80/778/EEC or
— has an impact deemed unacceptable on non-target species
(1) OJ L 194, 25.7.1975, p. 26. Directive as last amended by Directive 91/692/EEC (OJ L 377, 31.12.1991, p. 48).EN Official Journal of the European Communities L 123/61 24.4.98
unless it is scientifically demonstrated that under relevant field conditions this concentration is not
exceeded.
84. The proposed instructions for use of the biocidal product, including procedures for cleaning
application equipment, must be such that the likelihood of accidental contamination of water or itssediments is minimised.
Soil
85. Where unacceptable contamination of soil is likely to occur, the Member State shall not authorise a
biocidal product if the active substance or substance of concern contained in it, after use of the biocidalproduct:
— during tests in the field, persists in soil for more than one year, or— during laboratory tests, forms non-extractable residues in amounts exceeding 70% of the initial
dose after 100 days with a mineralisation rate of less than 5% in 100 days,
— has unacceptable consequences or effects on non-target organisms,unless it is scientifically demonstrated that under field conditions there is no unacceptable accumulation
in soil.
Air
86. The Member State shall not authorise a biocidal product where there is a foreseeable possibility of
unacceptable effects on the air compartment unless it is scientifically demonstrated that under relevantfield conditions there is no unacceptable effect.
Effects on non-target organisms
87. The Member State shall not authorise a biocidal product where there is a reasonably foreseeable
possibility of non-target organisms being exposed to the biocidal product if for any active substance orsubstance of concern:
— the PEC/PNEC is above 1 unless it is clearly established in the risk assessment that under field
conditions no unacceptable effects occur after use of the biocidal product according to the proposedconditions of use, or
— the bioconcentration factor (BCF) related to fat tissues in non-target vertebrates is above 1 unless it
is clearly established in the risk assessment that under field conditions no unacceptable effectsoccur, either directly or indirectly, after use of the product according to the proposed conditions ofuse.
88. The Member State shall not authorise a biocidal product where there is a reasonably foreseeable
possibility of aquatic organisms including marine and estuarine organisms being exposed to thebiocidal product if for any active substance or substance of concern in it:
— the PEC/PNEC is above 1 unless it is clearly established in the risk assessment that under field
conditions the viability of aquatic organisms including marine and estuarine organisms is notthreatened by the biocidal product according to the proposed conditions of use, or
— the bioconcentration factor (BCF) is greater than 1 000 for substances which are readily
biodegradable or greater than 100 for those which are not readily biodegradable unless it is clearlyestablished in the risk assessment that under field conditions no unacceptable impact, either directlyor indirectly, occurs on the viability of exposed organisms including marine and estuarineorganisms after use of the biocidal product according to the proposed conditions of use.EN Official Journal of the European Communities L 123/62 24.4.98
By way of derogation from this paragraph, Member States may, however, authorise an anti-fouling
product used on commercial, public service and naval seagoing vessels for a period of up to 10 yearsfrom the date on which this Directive enters into force if similar fouling control cannot be achieved byother practicable means. When implementing this provision, Member States shall, if appropriate, takeinto account relevant International Maritime Organisation (IMO) resolutions and recommendations.
89. The Member State shall not authorise a biocidal product where there is a reasonably foreseeable
possibility of micro-organisms in sewage treatment plants being exposed to the biocidal product if forany active substance, substance of concern, relevant metabolite, breakdown or reaction product thePEC/PNEC ratio is above 1 unless it is clearly established in the risk assessment that under fieldconditions no unacceptable impact, either directly or indirectly, occurs on the viability of suchmicro-organisms.
Unacceptable effects
90. If the development of resistance to the active substance in the biocidal product is likely the Member
State shall take steps to minimise the consequences of this resistance. This may involve modification ofthe conditions of authorisation or even refusal of any authorisation.
91. An authorisation for a biocidal product intended to control vertebrates shall not be given unless:
— death is synchronous with the extinction of consciousness, or,— death occurs immediately, or,— vital functions are reduced gradually without signs of obvious suffering.For repellent products, the intended effect shall be obtained without unnecessary suffering and pain for
the target vertebrate.
Efficacy
92. Member States shall not authorise a biocidal product which does not possess acceptable efficacy when
used in accordance with the conditions specified on the proposed label or with other conditions ofauthorisation.
93. The level, consistency and duration of protection, control or other intended effects must, as a
minimum, be similar to those resulting from suitable reference products, where such products exist, orto other means of control. Where no reference products exist, the biocidal product must give a definedlevel of protection or control in the areas of proposed use. Conclusions as to the performance of thebiocidal product must be valid for all areas of proposed use and for all areas in the Member Stateexcept where the proposed label prescribes that the biocidal product is intended for use in specificcircumstances. Member States shall evaluate dose response data generated in trials (which must includean untreated control) involving dose rates lower than the recommended rate, in order to assess if therecommended dose is the minimum necessary to achieve the desired effect.
Summary
94. In each of the areas where risk assessments have been carried out, i.e. effects on humans, animals, and
the environment, the Member State shall combine the conclusions arrived at for the active substanceand the substances of concern to produce an overall conclusion for the biocidal product itself. Asummary should also be made of the efficacy assessment and of the unacceptable effects.
The result shall be:
— a summary of the effects of the biocidal product on humans,— a summary of the effects of the biocidal product on animals,EN Official Journal of the European Communities L 123/63 24.4.98
— a summary of the effects of the biocidal product on the environment,
— a summary of the efficacy assessment,— a summary of the unacceptable effects.
OVERALL INTEGRATION OF CONCLUSIONS
95. The Member State shall combine the individual conclusions arrived at with regard to effects of the
biocidal product on the three sectors namely, humans, animals and the environment to arrive at anoverall conclusion for the global effect of the biocidal product.
96. The Member State shall then take due consideration of any relevant unacceptable effects, the efficacy
of the biocidal product and the benefits of using the biocidal product before taking an authorisationdecision on the biocidal product.
97. The Member State shall ultimately decide whether or not the biocidal product can be authorised and
whether this authorisation shall be subject to any restrictions or conditions in conformity with thisAnnex and this Directive.