1998L0008 — EN — 20.11.2003 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B DIRECTIVE98/8/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of16February1998
concerningtheplacingofbiocidalproductsonthemarket
(OJ L 123, 24.4.1998, p. 1)
Amended by:
Official Journal
No page date
►M1Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
Corrected by:
►C1Corrigendum, OJ L 150, 8.6.2002, p. 71 (98/8/EC)
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DIRECTIVE98/8/ECOF THE EUROPEANPARLIAMENTAND
OFTHECOUNCIL
of16February1998
concerningtheplacingofbiocidalproductsonthemarket
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 Conciliation Committee,
(1)Whereas, in their resolution of 1 February 1993 on a Communityprogramme of policy and action in relation to the environment
and sustainable development (
4), the Council and the representa-
tives of the Governments of the Member States, meeting withinthe Council, approved the general approach and strategy of theprogramme presented by the Commission, in which the needfor risk management of non-agricultural pesticides is empha-
sised;
(2)Whereas, both when the eighth Amendment (5) to Council Direc-
tive 76/769/EEC of 27 July 1976, on the approximation of the
laws, regulations and administrative provisions of the MemberStates relating to restrictions on the marketing and use ofdangerous substances and preparations (
6) was adopted in 1989
and during the discussion in the Council on Directive 91/414/
EEC concerning the placing of plant protection products on the
market (7), the Council expressed concern at the lack of harmo-
nised Community provisions for biocides, formerly known asnon-agricultural pesticides, and invited the Commission toexamine the situation in Member States and the possibility foraction at Community level;
(3)Whereas biocidal products are necessary for the control oforganisms that are harmful to human or animal health and for
the control of organisms that cause damage to natural or manu-
factured products; whereas biocidal products can pose risks tohumans, animals and the environment in a variety of ways dueto their intrinsic properties and associated use patterns;
(4)Whereas the Commission review showed differences in the regu-latory situation in the Member States; whereas such differencesmay constitute barriers not only to trade in biocidal productsbut also to trade in products treated with them, thereby affecting
the functioning of the internal market; whereas, therefore, the
Commission proposed the development of a framework of rulesrelating to the placing on the market for use of biocidal products,1998L0008 — EN — 20.11.2003 — 001.001 — 2
(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 of 20 December 1996 (OJ C 69,
5.3.1997, p. 13) and Decision of the European Parliament of 13 May 1997
(OJ C 167, 2.6.1997, p. 24). Council Decision of 18 December 1997. Deci-
sion 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.
(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).
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taking as a condition a high level of protection for humans,
animals and the environment; whereas, having regard to the prin-ciple of subsidiarity, decisions taken at Community level should
be restricted to those necessary for the proper functioning of the
common market and to avoid duplication of work by MemberStates; whereas a directive on biocidal products is the mostappropriate way of establishing such a framework;
(5)Whereas the framework of rules should provide that biocidalproducts should not be placed on the market for use unless they
have complied with the relevant 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 isappropriate to provide for simplified authorisation procedures,including registration;
(7)Whereas it is appropriate that the applicant submit dossiers
which contain information which is necessary to evaluate the
risks that will arise from proposed uses of the product; whereasa common core data set for active substances and for biocidalproducts in which they are contained is necessary so as to assistboth the applicants seeking authorisation and those carrying outthe evaluation to decide on the authorisation; whereas, further-
more, specific data requirements need to be elaborated for each
of the product types covered by this Directive;
(8)Whereas it is necessary, when biocidal products are beingauthorised, to make sure that, when properly used for thepurpose intended, they are sufficiently effective and have nounacceptable effect on the target organisms such as resistance
or unacceptable tolerance, and, in the case of vertebrate animals,
unnecessary suffering and pain, and have, in the light of currentscientific and technical knowledge, no unacceptable effect on theenvironment and, in particular, on human or animal health;
(9)Whereas it is necessary to provide common principles for theevaluation and authorisation of biocidal products to ensure a
harmonised approach by Member States;
(10)Whereas Member States should not be prevented from imposing
additional requirements on the use of biocidal products in so faras these additional requirements are in conformity with Commu-nity law and in particular do not run counter to the provisions ofthis Directive; whereas such provisions are intended to protect
the environment and human and animal health by means such
as epidemic control and food and feedingstuff protection;
(11)Whereas, in the light of the diversity of both the activesubstances and the biocidal products concerned, the data andtest requirements should suit the individual circumstances andresult in an overall risk assessment;
(12)Whereas it is necessary to establish a Community list of active
substances permitted for inclusion in biocidal products; whereas
a Community procedure must be laid down for assessingwhether or not an active substance can be entered in theCommunity list; whereas the information that interested partiesmust submit with a view to admission of an active substance to
the list has to be specified; whereas active substances on the list
should be reviewed periodically, and, if appropriate, comparedwith each other under specific conditions, to take account ofdevelopments in science and technology;
(13)Whereas, when due account is taken of products which poseonly a low risk, their active substances should be incorporatedin a specific annex; whereas substances the main use of which
is non-pesticidal but which have some minor use as a biocide
either directly, or in a product consisting of an active substanceand a simple diluent should be incorporated in a separatespecific annex;
(14)Whereas when an active substance is evaluated for its entry orotherwise in the relevant annexes of the Directive, it is necessary1998L0008 — EN — 20.11.2003 — 001.001 — 3
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for such an evaluation to cover, where appropriate, the same
aspects as those covered by the evaluation made under Directive92/32/EEC of 30 April 1992 amending for the seventh time
Directive 67/548/EEC on the approximation of the laws, regula-
tions and administrative provisions relating to the classification,packaging and labelling of dangerous substances (
1) and Council
Regulation (EEC) No 793/93 of 23 March 1993 on the evalua-tion and control 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 activesubstance and materials treated with it are to be considered in asimilar way as they are in the aforementioned legislation;
(15)Whereas it is in the interest of the free circulation of biocidal
products, as well as of materials treated with them, that authori-
sation granted by one Member State should be recognised byother Member States subject to the specific conditions containedin this Directive;
(16)Whereas, while envisaging harmonised provisions for allbiocidal product types, including those intended to control verte-
brates, the actual use of such types might give rise to concern;
whereas therefore Member States should be allowed, subject tothe Treaty, to derogate from the principle of mutual recognitionfor biocidal products falling under three particular types ofbiocides whenever intended to control particular kinds of verte-
brates, in so far as such derogations are justified and do not
jeopardise the purpose of this Directive;
(17)Whereas it is therefore desirable that a system for the mutualexchange of information should be established and that MemberStates and the Commission should make available to each otheron request the particulars and scientific documentation submitted
in connection with applications for authorisation of biocidal
products;
(18)Whereas it should be possible for Member States to authorise,for a limited period of time, biocidal products which do notcomply with the abovementioned conditions, especially in the
event of an unforeseen danger threatening humans, animals or
the environment which cannot be contained by other means;whereas the Community procedure should not prevent MemberStates from authorising, for a limited period of time for use intheir territory, biocidal products containing an active substancenot yet entered in the Community list, provided that a dossier
meeting Community requirements has been submitted and the
Member State concerned believes that the active substance andthe biocidal product satisfy the Community conditions set forthem;
(19)Whereas it is essential that this Directive helpto minimise the
number of tests on animals and that testing should be made
dependent on the purpose and use of a product;
(20)Whereas close coordination should be ensured with otherCommunity legislation and in particular with Directive 91/414/EEC, the Directives concerned with the protection of water andthose concerned with the contained use and deliberate release of
genetically modified organisms;
(21)Whereas the Commission is to draw uptechnical notes for
guidance in particular on the implementation of the authorisationprocedures, the entry of active substances in the appropriateAnnexes, the Annexes relating to data requirements and the
Annex dealing with the common principles;
(22)Whereas, in order to ensure that the requirements laid down in
respect of authorised biocidal products are satisfied when they1998L0008 — EN — 20.11.2003 — 001.001 — 4
(1) OJ L 154, 5.6.1992, p. 1.
(2) OJ L 84, 5.4.1993, p. 1.
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are placed on the market, Member States should make provision
for appropriate control and inspection arrangements;
(23)Whereas the implementation of this Directive, the adaptation ofits Annexes to the development of technical and scientific
knowledge and the inclusion of active substances in the appro-
priate Annexes necessitate close cooperation between theCommission, the Member States and the applicants; whereas, incases where the procedure of the Standing Committee onBiocidal Products is to be applied, this constitutes a suitablebasis for such cooperation;
(24)Whereas an agreement on a modus vivendi between the
European Parliament, the Council and the Commission
concerning the implementing measures for acts adopted in accor-dance with the procedure laid down in Article 189b of the ECTreaty was reached on 20 December 1994 (
1);
(25)Whereas the Commission will apply the modus vivendi to the
implementing measures flowing from this Directive that it envi-sages adopting, including those concerning Annexes IA and IB;
(26)Whereas, since the full implementation of this Directive, andespecially the review programme, will not be achieved for
several years, Directive 76/769/EEC provides a framework to
complement the development of the positive list by limitationsof the marketing and use of certain active substances andproducts or groups thereof;
(27)Whereas the review programme on active substances will needto take account of other work programmes within the frameworkof other Community legislation concerned with the review or
authorisation of substances and products or relevant international
Conventions;
(28)Whereas the costs of the procedures associated with the opera-tion of the Directive need to be recovered from those seekingto place, or placing, biocidal products on the market and fromthose supporting the 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 it is desirable to developfurther rules in this area,
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 in biocidal products.
2. This Directive shall apply to biocidal products as defined in
Article 2(1)(a) but shall exclude products that are defined or withinthe scope of the following instruments for the purposes of these Direc-
tives:
(a) Council Directive 65/65/EEC of 26 January 1965 on the approxi-
mation of provisions laid down by law, regulation oradministrative action relating to proprietary medicinal products (
2),1998L0008 — EN — 20.11.2003 — 001.001 — 5
(1) OJ C 102, 4.4.1996, p. 1.
(2) OJ 22, 9.2.1965, p. 369. Directive as last amended by Directive 93/39/EEC
(OJ L 214, 24.8.1993, p. 22).
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(b) Council Directive 81/851/EEC of 28 September 1981 on the
approximation of the laws of the Member States on veterinarymedicinal products (
1),
(c) Council Directive 90/677/EEC of 13 December 1990 extending the
scope of Directive 81/851/EEC on the approximation of the laws
of the Member States relating to veterinary medicinal productsand laying down additional provisions for immunological medic-inal products (
2),
(d) Council Directive 92/73/EEC of 22 September 1992 widening the
scope of Directives 65/65/EEC and 75/319/EEC on the approxima-
tion of provisions laid down by law, regulation or administrative
action relating to medicinal products and laying down additionalprovisions on homeopathic medicinal products (
3),
(e) Council Directive 92/74/EEC of 22 September 1992 widening the
scope of Directive 81/851/EEC on the approximation of provisionslaid down by law, regulation or administrative action relating toveterinary medicinal products and laying down additional provi-
sions on homeopathic veterinary medicinal products (
4),
(f) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying
down Community procedures for the authorisation and supervisionof medicinal products for human and veterinary use and estab-lishing a European Agency for the Evaluation of MedicinalProducts (
5),
(g) Council Directive 90/385/EEC of 20 June 1990 on the approxima-
tion of the laws of the Member States relating to active
implantable medical devices (6),
(h) Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices (7),
(i) Council Directive 89/107/EEC of 21 December 1988 on the
approximation of the laws of the Member States concerning foodadditives authorised for use in foodstuffs intended for humanconsumption (
8), Council Directive 88/388/EEC of 22 June 1988
on the approximation of the laws of the Member States relating
to flavourings for use in foodstuffs and to source materials fortheir production (
9) and European Parliament and Council Direc-
tive No 95/2/EC of 20 February 1995 on food additives otherthan colours and sweeteners (
10),
(j) Council Directive 89/109/EEC of 21 December 1988 on the
approximation of the laws of the Member States relating to mate-
rials and articles intended to come into contact with foodstuffs(11),
(k) Council Directive 92/46/EEC of 16 June 1992 laying down the
health rules for the production and placing on the market of rawmilk, heat-treated milk and milk based products (
12),1998L0008 — EN — 20.11.2003 — 001.001 — 6
(1) 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).
(2) OJ L 373, 31.12.1990, p. 26.
(3) OJ L 297, 13.10.1992, p. 8.
(4) OJ L 297, 13.10.1992, p. 12.
(5) OJ L 214, 24.8.1993, p. 1.
(6) 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).
(7) OJ L 169, 12.7.1993, p. 1.
(8) OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive 94/34/EC (OJ
L 237, 10.9.1994, p. 1).
(9) OJ L 184, 15.7.1988, p. 61. Directive as amended by Directive 91/71/EEC
(OJ L 42, 15.2.1991, p. 25).
(10) OJ L 61, 18.3.1995, p. 1. Directive as amended by Directive 96/85/EC (OJ
L 86, 28.3.1997, p. 4).
(11) OJ L 40, 11.2.1989, p. 38.
(12) 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).
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(l) Council Directive 89/437/EEC of 20 June 1989 on hygiene and
health problems affecting the production and the placing on themarket of egg products (
1),
(m) Council Directive 91/493/EEC of 22 July 1991 laying down the
health conditions for the production and the placing on the marketof fishery products (
2),
(n) Council Directive 90/167/EEC of 26 March 1990 laying down the
conditions governing the preparation, placing on the market anduse of medicated feedingstuffs in the Community (
3),
(o) Council Directive 70/524/EEC of 23 November 1970 concerning
additives in feedingstuffs (4), Council Directive 82/471/EEC of 30
June 1982 on certain products used in animal nutrition (5) and
Council Directive 77/101/EEC of 23 November 1976 on themarketing of straight feedingstuffs (
6),
(p) Council Directive 76/768/EEC of 27 July 1976 on the approxima-
tion of the laws of the Member States relating to cosmetic
products (7),
(q) Council Directive 95/5/EC of 27 February 1995 amending Direc-
tive 92/120/EEC on the conditions for granting temporary andlimited derogations from specific Community health rules on theproduction and marketing of certain products of animal origin (
8),
(r) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (9).
3. This Directive shall apply, without prejudice to relevant Commu-
nity provisions or measures taken in accordance with them, inparticular, to:
(a) Council Directive 76/769/EEC of 27 July 1976 on the approxima-
tion of the laws, regulations and administrative provisions of the
Member States relating to restrictions on the marketing and use of
certain dangerous substances and preparations (
10),
(b) Directive 79/117/EEC of 21 December 1978 prohibiting the placing
on the market and use of plant protection products containingcertain active substances (
11),
(c) Council Regulation (EEC) No 2455/92 of 23 July 1992 concerning
the export and import of certain dangerous chemicals (12),
(d) Council Directive 80/1107/EEC of 27 November 1980, on the
protection of workers from the risks related to exposure to
chemical, physical and biological agents at work(13), Council
Directive 89/391/EEC of 12 June 1989 on the introduction ofmeasures to encourage improvements in the safety and health of1998L0008 — EN — 20.11.2003 — 001.001 — 7
(1) OJ L 212, 22.7.1989, p. 87. Directive as last amended by the 1994 Act of
Accession.
(2) 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).
(3) OJ L 92, 7.4.1990, p. 42.
(4) 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).
(5) 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).
(6) OJ L 32, 3.2.1977, p. 1. Directive as last amended by the 1994 Act of
Accession.
(7) 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).
(8) OJ L 51, 8.3.1995, p. 12.
(9) 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).
(10) 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).
(11) OJ L 33, 8.2.1979, p. 36. Directive as last amended by the 1994 Act of
Accession.
(12) 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).
(13) OJ L 327, 3.12.1980, p. 8. Directive as last amended by the 1994 Act of
Accession.
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workers at work(1) and individual Directives based on these Direc-
tives,
(e) Council Directive 84/450/EEC of 10 September 1984 relating to
the approximation of the laws, regulations or administrative provi-sions of the Member States concerning misleading advertising (
2).
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 which they are supplied to theuser, intended to destroy, deter, render harmless, prevent the actionof, or otherwise exert a controlling effect on any harmful organism
by chemical or biological means.
An exhaustive list of 23 product types with an indicative set of
descriptions within each type is given in Annex V.
(b)Low-riskbiocidal product
A biocidal product which contains as active substance(s) only one
or more of those listed in Annex I A and which does not containany substance(s) of concern.
Under the conditions of use, the biocidal product shall pose only a
low risk to humans, animals and the environment.
(c)Basicsubstance
A substance which is listed in Annex I B, whose major use is non-
pesticidal but which has some minor use as a biocide either directlyor in a product consisting of the substance and a simple diluentwhich itself is not a substance of concern and which is not directly
marketed for this biocidal use.
The substances, which could potentially enter Annex IB in accor-
dance with the procedure laid down in Articles 10 and 11, areinteralia 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 against harmful organisms.
(e)Substanceofconcern
Any substance, other than the active substance, which has an
inherent capacity to cause an adverse effect on humans, animals
or the environment and is present or is produced in a biocidalproduct in sufficient concentration to create such an effect.1998L0008 — EN — 20.11.2003 — 001.001 — 8
(1) OJ L 183, 29.6.1989, p. 1.
(2) OJ L 250, 19.9.1984, p. 17.
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Such a substance, unless there are other grounds for concern, would
be normally a substance classified as dangerous according toCouncil Directive 67/548/EEC of 27 June 1967 on the approxima-
tion of laws, regulations and administrative provisions relating to
the classification, packaging and labelling of dangeroussubstances (
1), and present in the biocidal product at a concentra-
tion leading the product to be regarded as dangerous within themeaning of Article 3 of Council Directive 88/379/EEC of 7 June
1988 on the approximation of the laws, regulations and administra-
tive provisions of the Member States relating to the classification,packaging and labelling of dangerous preparations (
2).
(f)Harmfulorganism
Any organism which has an unwanted presence or a detrimental
effect for humans, their activities or the products they use or
produce, or for animals or for the environment.
(g)Residues
One or more of the substances present in a biocidal product which
remains as a result of its use including the metabolites of such
substances and products resulting from their degradation or reac-
tion.
(h)Placing onthemarket
Any supply, whether in return for payment or free of charge, or
subsequent storage other than storage followed by consignment
from the customs territory of the Community or disposal. Importa-tion of a biocidal product into the customs territory of theCommunity shall be deemed to constitute placing on the marketfor the purposes of this Directive.
(i)Authorisation
An administrative act by which the competent authority of a
Member State authorises, following an application submitted byan applicant, the placing on the market of a biocidal product in itsterritory or in a part thereof.
(j)Frame-formulation
Specifications for a group of biocidal products having the same use
and user type.
This groupof p roducts must contain the same active substances of
the same specifications, and their compositions must present only
variations from a previously authorised biocidal product which do
not affect the level of risk associated with them and their efficacy.
In this context, a variation is the allowance of a reduction in the
percentage of the active substance and/or an alteration in percen-tage composition of one or more non-active substances and/or the
replacement of one or more pigments, dyes, perfumes by others
presenting the same or a lower risk, and which do not decrease itsefficacy.
(k)Registration
An administrative act by which the competent authority of a
Member State, following an application submitted by an applicant,
after verification that the dossier meets the relevant requirements ofthis Directive, allows the placing on the market of a low-riskbiocidal product in its territory or in a part thereof.
(l)Letterofaccess
A document, signed by the owner or owners of relevant data
protected under the provisions of this Directive, which states thatthese data may be used by the competent authority for the purposeof granting an authorisation or a registration of a biocidal productunder this Directive.1998L0008 — EN — 20.11.2003 — 001.001 — 9
(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).
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2. For the purposes of this Directive the definitions for:
(a) substance,
(b) preparation,(c) scientific research and development,
(d) process-orientated research and development
laid down in Article 2 of Council Directive 67/548/EEC shall apply.
Article 3
Authorisationforplacingonthemarketofbiocidal products
1. Member States shall prescribe that a biocidal product shall not be
placed on the market and used in their territory unless it has been
authorised in accordance with 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-risk biocidal product, provided that a
dossier in accordance 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 to registration.
(ii) Member States shall allow the placing on the market and use of
commodity substances for biocidal purposes 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 authority shall take a decision within a period of60 days.
4. Member States shall, on request, or may, on their own initiative,
and where relevant, establish a frame-formulation and communicate itto the applicant when 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 the frame-formulation in the form of a letter ofaccess, when a subsequent application for authorisation for a newbiocidal product is based on this frame-formulation, the competentauthority shall take a decision with regard to this application within aperiod of 60 days.
5. Member States shall prescribe that biocidal products are to be
classified, packaged and labelled in accordance with the provisions ofthis Directive.
6. Without prejudice to Article 7(1), authorisations shall be granted
for a maximum period of 10 years from the date of first or renewed
inclusion of the active substance in Annex I or I A for the product
type, without exceeding the deadline specified for the active substancein Annex I or I A; they may be renewed after verification that theconditions imposed in Article 5(1) and (2) are still satisfied. Renewalmay, where necessary, be granted only for the period necessary to
allow the competent authorities of the Member States to make such
verification, where an application for renewal has been made.
7. Member States shall prescribe that biocidal products are to be
properly used. Proper use shall include compliance with conditionsestablished pursuant to Article 5 and specified under the labelling
provisions of this Directive. Proper use shall also involve the rational
application of a combination of physical, biological, chemical or othermeasures as appropriate, whereby the use of biocidal products islimited to the minimum necessary. Where biocidal products are usedat work, use shall also be in accordance with the requirements ofDirectives for the protection of workers.1998L0008 — EN — 20.11.2003 — 001.001 — 10
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Article 4
Mutualrecognitionofauthorisations
1. Without prejudice to Article 12, a biocidal product that has
already been authorised or registered in one Member State shall beauthorised or registered in another Member State within 120 days, or60 days respectively, of an application being received by the otherMember State, provided that the active substance of the biocidalproduct is included in Annex I or I A and conforms to the requirements
thereof. For the mutual recognition of authorisations, the application
shall include a summary of the dossier as required in Article 8(2)(a)and Annex II B, Section X and a certified copy of the first authorisa-tion granted. For mutual recognition of registration of low-risk biocidalproducts, the application shall include the data requirements of Article
8(3), except for the efficacy data for which a summary shall suffice.
The authorisation may be subject to provisions resulting from the
implementation of other measures in accordance with Community law,relating to the conditions for distribution and use of biocidal productsintended to protect the health of the distributors, users and workers
concerned.
This mutual recognition procedure shall be without prejudice to
measures taken by Member States pursuant to Community law intendedto protect the health of workers.
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, differ significantly from those in theMember State where the biocidal product was first authorised, and
an unchanged authorisation may therefore present unacceptable
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) be adjusted to the different circum-stances, so that conditions for issue of an authorisation laid down inArticle 5 are satisfied.
3. Where a Member State believes that a low-risk biocidal product
which has been registered by another Member State does not complywith the definition provided for in Article 2(1)(b), it may provisionallyrefuse registration thereof and shall immediately communicate itsconcerns to the competent authority responsible for the verification of
the dossier.
If, within a maximum period of 90 days, an agreement is not reached
between the authorities concerned, the matter will be forwarded to theCommission for a decision in accordance with the procedure laid downin paragraph 4.
4. Notwithstanding paragraphs 2 and 3, where a Member State
believes a biocidal product authorised by another Member State cannotmeet the conditions set out pursuant to Article 5(1) and consequentlyproposes to refuse the authorisation or the registration or to restrictthe authorisation under certain conditions, it shall notify the Commis-
sion, other Member States and the applicant and shall provide them
with an explanatory document containing the name of the product andits specification and setting out the grounds on which it proposes torefuse or to restrict the authorisation.
The Commission shall prepare a proposal on these matters in accor-
dance with Article 27 for a decision in accordance with the procedure
laid down in Article 28(2).
5. If the procedure laid down in paragraph 4 leads to the confirma-
tion of a refusal of a second or subsequent registration by a MemberState, the Member State that had previously registered the low-riskbiocidal product shall, where deemed appropriate by the Standing1998L0008 — EN — 20.11.2003 — 001.001 — 11
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Committee, take this refusal into consideration and review its registra-
tion according to Article 6.
If this procedure confirms the initial registration, the Member State
having introduced the procedure shall register the low-risk biocidalproduct concerned.
6. By way of derogation from paragraph 1, Member States may
refuse, subject to the Treaty, mutual recognition of authorisationsgranted for product types 15, 17 and 23 of Annex V provided thatsuch a limitation can be justified and does not jeopardise the purpose
of the Directive.
Member States shall inform each other and the Commission of any
decision taken in this respect and indicate the reasons therefor.
Article 5
Conditionsforissueofanauthorisation
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 in these Annexes are fulfilled;
(b) it is established, in the light of current scientific and technical
knowledge, and is shown from appraisal of the dossier providedfor in Article 8, according to the common principles for the evalua-
tion of dossiers as laid down in Annex VI, that, when used as
authorised 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 or cross-resistance or unnecessarysuffering and pain 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. throughdrinking water, food or feed, indoor air or consequences in theplace of work) or on surface water and groundwater,
(iv) has no unacceptable effect itself, or as a result of its residues,
on the environment having 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 appro-
priate, any toxicologically or ecotoxicologically significantimpurities and co-formulants, and its residues of toxicological or
environmental significance, which result from authorised uses, can
be determined according to the relevant requirements in Annex IIA,IIB, IIIA, IIIB, IVA or IVB;
(d) its physical and chemical properties have been determined and
deemed acceptable for purposes of the appropriate use, storageand transport of the product.
2. A biocidal product classified according to Article 20(1) as toxic,
very toxic or as a category 1 or 2 carcinogen, or as a category 1 or 2mutagen or classified as toxic for reproduction category 1 or 2, shallnot be authorised for marketing to, or use by the general public.
3. Authorisation may be conditional on, and must stipulate the
conditions relating to marketing and use necessary to ensure compli-ance with the provisions of paragraph 1.1998L0008 — EN — 20.11.2003 — 001.001 — 12
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4. Where other Community provisions impose requirements relevant
to the conditions for the issue of an authorisation and for use of thebiocidal product, and particularly where these are intended to protect
the health of distributors, users, workers and consumers or animal
health or the environment, the competent authority shall take theseinto account when issuing an authorisation and where necessary shallissue the authorisation subject to those requirements.
Article 6
Reviewofanauthorisation
During the period for which an authorisation has been granted, it may
be reviewed at any time, e.g. following information received accordingto Article 14, if there are indications that any of the conditions referredto in Article 5 are no longer satisfied. In such instances the MemberStates may require the authorisation holder, or the applicant to whom
a modification of the authorisation has been granted in accordance
with Article 7, to submit further information necessary for the review.If need be, the authorisation may be prolonged only for the periodnecessary to complete the review, but shall be prolonged for the periodnecessary to provide for further information.
Article 7
Cancellationormodificationofanauthorisation
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 of which the authorisation was
granted.
2. An authorisation may also be cancelled if the authorisation holder
so requests and states the reasons for the cancellation.
3. When a Member State intends to cancel an authorisation, it shall
inform and hear the authorisation holder. When cancelling the authori-
sation, the Member State may grant a period of grace for the disposal
or for the storage, marketing and use of existing stocks, of a length inaccordance with the reason for the cancellation without prejudice toany period provided for by decision taken pursuant to Directive 76/769/EEC or in connection with paragraph 1(a).
4. Where a Member State considers it necessary, on the basis of
developments in scientific and technical knowledge and to protecthealth and the environment, it shall modify the conditions of use ofan authorisation and, 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 for the modification.
6. Where a proposed modification concerns an extension of uses, a
Member State shall extend the authorisation subject to the particularconditions placed on the active substance listed in Annex I or IA.
7. Where a proposed modification of an authorisation involves
changes to the particular conditions placed on the active substance
listed in Annex I or IA, such changes can be made only after evalua-tion of the active substance, with regard to the proposed changes, inaccordance with the procedures laid down in Article 11.
8. Modifications shall be granted only if it is established that the
conditions within the meaning of Article 5 remain satisfied.1998L0008 — EN — 20.11.2003 — 001.001 — 13
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Article 8
Requirementsforauthorisation
1. Application for authorisation shall be made by, or on behalf of,
the person who will be responsible for the first placing on the market
of a biocidal product in a particular Member State and shall be to thecompetent authority of that Member State. Every applicant shall berequired to have a permanent office within the Community.
2. Member States shall require that an applicant for authorisation of
a biocidal product shall submit to the competent authority:
(a) a dossier or a letter of access for the biocidal product satisfying, in
the light of current scientific and technical knowledge, the require-ments set out in Annex IIB and, where specified, the relevant partsof Annex IIIB, and
(b) for each active substance in the biocidal product, a dossier or a
letter of access satisfying, in the light of current scientific and tech-
nical knowledge, the requirements set out in Annex IIA and, where
specified, the relevant parts of Annex IIIA.
3. By way of derogating from paragraph 2(a), Member States shall
require a dossier comprising the following data 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 of manufacturer 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 of 7 June 1988 on the approxima-
tion of the laws, regulations, and administrative provisions of the
Member States relating to the classification, packaging and label-ling 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 methods used or a bibliographical refer-ence to those methods. The information in the dossiers supplied inaccordance with Article 8(2) shall be sufficient for an evaluation to be
made of the effects and properties referred to in Article 5(1)(b), (c) and
(d). It shall be submitted to the competent authority in the form oftechnical dossiers, containing the information and results of the studies1998L0008 — EN — 20.11.2003 — 001.001 — 14
(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).
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referred 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 uses need not be supplied. Thesame applies where it is not scientifically necessary or technically
possible to supply the information. In such cases, a justification, accep-
table to the competent authority must be submitted. Such a justificationmay be the existence of a frame-formulation which the applicant hasthe right to access.
6. If the evaluation of the dossier shows that further information,
including data and results from further testing, is necessary to evaluatethe risks of the biocidal product, the competent authority shall ask theapplicant to submit such information. The time period for the evalua-
tion of the dossier shall start only after the dossier is complete.
7. The name of an active substance must be given as registered in
the list contained in Annex I to Directive 67/548/EEC or, if the name
is not included therein, as given in the European Inventory of ExistingChemical Substances (Einecs), or, if the name is not included therein,the active substance must be given its International Standards Organi-sation (ISO) common name. If the latter is not available, the substancemust be designated by its chemical designation according to Interna-
tional 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 to Directive 67/548/EEC. In the event
of a method being inappropriate or not described, other methods usedshould, whenever possible, be internationally recognised and must bejustified. Where appropriate, tests must be conducted in accordancewith the provisions laid down in Council Directive 86/609/EEC of 24November 1986 on the approximation of laws, regulations and admin-
istrative provisions of the Member States regarding the protection of
animals used for experimental and other scientific purposes(
1) and
Council Directive 87/18/EEC of 18 December 1986 on the harmonisa-tion of laws, regulations and administrative provisions relating to theapplication of the principles of good laboratory practice and the verifi-
cation of their applications for tests on chemical substances (
2).
9. Where test data exist that have been generated before the adop-
tion of this Directive by methods other than those laid down in Annex
V to Directive 67/548/EEC, the adequacy of such data for the purposes
of this Directive and the need to conduct new tests according to AnnexV must be decided on a case-by-case basis, taking into account, amongother factors, the need to minimise testing on vertebrate animals.
10. Competent authorities as referred to within the meaning of
Article 26 shall ensure that a file is compiled on each application.Each file shall contain at least a copy of the application, a record ofthe administrative decisions taken by the Member State concerning
the application and concerning the dossiers submitted in accordance
with paragraph 2, together with a summary of the latter. On request,Member States shall make available to the other competent authoritiesand to the Commission the files provided for in this paragraph; theyshall supply to them, on request, all information necessary for full
comprehension of applications and shall, where requested, ensure that
applicants provide a copy of the technical documentation laid down 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 official languages or one of theselanguages.1998L0008 — EN — 20.11.2003 — 001.001 — 15
(1) OJ L 358, 18.12.1986, p. 1.
(2) OJ L 15, 17.1.1987, p. 29.
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Article 9
Placingonthemarketofactivesubstances
Member States shall prescribe that where a substance is an active
substance for use in biocidal products it may not be placed on themarket for such use unless:
(a) where the active substance was not on the market before the date
referred to in Article 34(1), a dossier has been forwarded to aMember State, which satisfies the requirements of Article 11(1)and is accompanied by the declaration that the active substance is
intended for inclusion in a biocidal product. This shall not apply to
substances for use pursuant to Article 17;
(b) it is classified, packaged and labelled in accordance with the provi-
sions of Directive 67/548/EEC.
Article 10
InclusionofanactivesubstanceinAnnexesI,IAorIB
1. In the light of current scientific and technical knowledge, an
active substance shall be included in Annex I, Annex IA or IB for an
initial period not exceeding 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, cumulation effects from the useof biocidal products containing the same 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 between which the substance can beused.
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 informa-
tion which has been made available in the context of thisDirective;
(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.1998L0008 — EN — 20.11.2003 — 001.001 — 16
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3. The inclusion in Annex I, IA or IB of an active substance shall be
restricted to those product types in Annex V for which relevant datahave been submitted in accordance with Article 8.
4. The inclusion of an active substance in Annex I, IA or IB may be
renewed on one or more occasions for periods not exceeding 10 years.
The initial inclusion, as well as any renewed inclusion, may be
reviewed at any time if there are indications that any of the require-ments referred to in paragraph 1 are not longer satisfied. Renewalmay, where necessary, be granted only for the minimum period neces-sary to complete a review, where an application has been made forsuch renewal, and shall be granted for the period necessary to provide
further information 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 or removed,
— if the evaluation of the active substance in accordance with
Article 11(2) shows that, under normal conditions underwhich it may be used in authorised biocidal products, risksto health or the environment still give rise to concern, and
— if there is another active substance on Annex I for the same
product type which, in the light of scientific or technicalknowledge, presents significantly less risk to health or tothe environment.
When such a refusal or removal is considered, an assessment of
an alternative active substance or substances shall take place to
demonstrate that it can be used with similar effect on the targetorganism without significant economic and practical disadvan-tages for the user and without an increased risk for health orfor the environment.
The assessment shall be circulated in accordance with the
procedures in Article 11(2) for decision in accordance with theprocedures laid down in Articles 27 and 28(3).
(ii) The refusal or removal of an Annex I and, where relevant, IA
or IB entry shall be carried out under the following conditions:
1. the chemical diversity of the active substances should be
adequate to minimise occurrence of resistance in the target
organism;
2. it should be applied only to active substances which, when
used under normal conditions in authorised biocidalproducts, present a significantly 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 acquiring experience from use in prac-tice, if it is not already available;
5. the complete data dossiers of the evaluation serving or
having served for entry in Annex I, IA or IB shall be put atthe disposal of the Committee 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 a period of up to amaximum of four years from the date of that decision.
Article 11
ProcedureforinclusionofanactivesubstanceinAnnexI,IAorIB
1. Inclusion, or subsequent changes to the inclusion, of an active
substance in Annex I, IA or IB shall be considered 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 requirements of Annex IIA and, wherespecified, the relevant parts of Annex IIIA;1998L0008 — EN — 20.11.2003 — 001.001 — 17
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(ii) a dossier for at least one biocidal product containing the active
substance satisfying the requirements of Article 8, with theexception of paragraph 3 thereof;
(b) the receiving competent authority has verified the dossiers and
believes them to satisfy the requirements of Annex IVA and Annex
IVB or the requirements of Annex IIA and Annex IIB and, whererelevant, Annexes IIIA and IIIB, accepts them and agrees to theapplicant forwarding a summary of the dossiers to the Commissionand the other Member States.
2. The receiving competent authority shall, within 12 months of
accepting the dossiers, carry out an evaluation thereof. A copy of theevaluation shall be sent by the competent authority to the Commission,the other Member States and to the applicant, together with a recom-
mendation for the inclusion, or otherwise, of the active 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 the applicant submit such information. The 12-
month period shall be suspended from the date of issue of the compe-tent authority's request until the date the information is received. Thecompetent authority shall inform the other Member States and theCommission of its action when it informs the applicant.
3. To avoid dossiers being evaluated by only a few Member States,
the evaluation can be carried out by Member States other than thereceiving one. A request for this shall be given when the dossiers areaccepted, and the decision shall be taken in accordance with the proce-
dure laid down in Article 28(2). The decision shall be taken at the
latest one month after receipt by the Commission of the request.
4. On receipt of the evaluation, the Commission shall, in accordance
with the procedure in Article 27, prepare a proposal without undue
delay for decision in accordance with the procedure laid down in
Article 28(3). The decision shall be taken at the latest 12 months afterthe receipt by the Commission of the evaluation referred to in para-graph 2.
Article 12
Useofdataheldbycompetentauthoritiesforotherapplicants
1. Member States shall not make use of the information referred to
in Article 8 for the benefit of a second or subsequent applicant:
(a) unless the second or subsequent applicant has the written agree-
ment in the form of a letter of access of the first applicant that
use may be made of such information, or
(b) in the case of an active substance not on the market on the date
referred to in Article 34(1), for a period of 15 years from the dateof first inclusion in Annex 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 information submitted for the purposes of thisDirective, except where such information is already protected
under existing national rules relating to biocidal products. In
such cases, the information shall continue to be protected inthat Member State until the expiry of any remaining period ofdata protection provided for under national rules, up to amaximum of 10 years from the date referred to in Article34(1);
(ii) for a period of 10 years from the date of entry of an active
substance onto Annex I or IA for information submitted forthe first time in support of the first inclusion in Annex I or IAof either the active substance or an additional product type forthat active substance,1998L0008 — EN — 20.11.2003 — 001.001 — 18
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(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 the five-year period expiresbefore the period provided for in paragraphs 1(b) and (c), in which
case the period of five years shall be extended so as to expire on
the same date as those periods.
2. Member States shall not make use of the information referred to
in Article 8, for the benefit of a second or subsequent applicant:
(a) unless the second or subsequent applicant has the written agree-
ment in the form of a letter of access of the first applicant thatuse may be made of such information; or
(b) in the case of a biocidal product containing an active substance not
on the market on the date referred to in Article 34(1) for a period
of 10 years from the 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 referred to in Article 34(1);
(i) for a period of 10 years from the date referred to in Article
34(1) for any information submitted for the purposes of this
Directive, except in the case where data are already protectedaccording to existing national rules relating to biocidalproducts, in which case such data shall be protected in thatMember State until the expiry of any remaining period of dataprotection provided for under those national rules, up to a
maximum of 10 years from the date 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, for information which is
submitted for the first time in support of the inclusion in AnnexI or IA either 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-year period expires before the periodin paragraphs (b) and (c), in which case the period of five yearsshall be extended so as to expire on the same date as those periods.
3. For decisions to be taken in accordance with Article 10(5), the
information referred to in paragraphs 1 and 2 can be used by theCommission, the Scientific Committees as referred to in Article 27
and the Member States.
Article 13
Cooperation in the use of data for second and subsequentapplica-
tionsforauthorisation
1. In the case of a biocidal product which has already been
authorised in accordance with Articles 3 and 5, and without prejudiceto the obligations imposed pursuant to Article 12, the competent
authority may agree that a second or subsequent applicant for authori-
sation may refer to data provided by the first applicant in so far as thesecond or subsequent applicant can provide evidence that the biocidalproduct is similar and its active substances are the same as the oneformerly authorised, including degree of purity and nature of impuri-ties.1998L0008 — EN — 20.11.2003 — 001.001 — 19
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2. Notwithstanding Article 8(2):
(a) an applicant for authorisation of biocidal products shall, before
carrying out experiments involving vertebrate animals, enquire ofthe competent authority 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 biocidal product for which authorisation
has been granted, 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 for authorisation on his own behalf and
that the other information specified in Article 8(2) is available;
(b) the competent authority of the Member State, if satisfied that the
applicant intends to apply, shall provide the name and address ofthe holder or holders of former relevant authorisations and shall atthe time inform the holders of the authorisations of the name andaddress of the applicant.
The holder or holders of former authorisations and the applicant
shall take all reasonable steps to reach agreement on the sharing
of information, so as to avoid, if possible, the duplication of testing
on vertebrate animals.
The competent authorities of the Member States shall encourage data-
holders to cooperate in the provision of the requested data, with a view
to limiting the duplication of testing on vertebrate animals.
If it is still not possible for the applicant and holders of former author-
isations of the same product to reach an agreement on the sharing of
data, Member States may introduce national measures obliging theapplicant and holders of former authorisations located within their terri-tory to share the data with a view to avoiding duplicative testing onvertebrate animals and determine both the procedure for utilising infor-mation, and the reasonable balance of the interests of the parties
concerned.
Article 14
Newinformation
1. Member States shall prescribe that the holder of an authorisation
for a biocidal product shall immediately notify the competent authority
of information of which he or she is aware or of which he or she may
reasonably be expected to be aware concerning an active substance or abiocidal product containing it and which may affect continuing author-isation. In particular, the following shall be notified:
— new knowledge or information on the effects of the active
substance or biocidal product for humans or the 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 such information they receive concerningpotentially harmful effects for humans or the environment or the newcomposition of a biocidal product, its active substances, impurities,co-formulants or residues.
Article 15
Derogationfromtherequirements
1. By way of derogating from Articles 3 and 5, a Member State may
authorise temporarily for a period not exceeding 120 days, the placingon the market of biocidal products not complying with the provisionsof this Directive for a limited and controlled use if such a measure1998L0008 — EN — 20.11.2003 — 001.001 — 20
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appears necessary because of an unforseen danger which cannot be
contained by other means. In this case, the Member State concernedshall immediately inform the other Member States and the Commission
of its action and the justification for it. The Commission shall make a
proposal and it shall be decided without delay, in accordance with theprocedure laid down in Article 28(2), whether, and, if so, under whatconditions, the action taken by the Member State may be extended fora period to be determined, be repeated, or be revoked.
2. By way of derogation from Article 5(1)(a) and until an active
substance is listed in Annex I or IA, a Member State may authorise
provisionally, for a period not exceeding three years, the placing onthe market of a biocidal product containing an active substance notlisted in Annex I or IA and not yet available on the market on thedate referred to in Article 34(1) for purposes other than those definedin Article 2(2)(c) and (d). Such an authorisation may be issued only if,
after dossiers have been evaluated in accordance with Article 11, the
Member 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 with Article 18(2), to thecompleteness of the dossiers. Where an objection is made, a decisionon the completeness of dossiers shall be taken in accordance with the
procedure laid 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 not satisfy the requirementsspecified in Article 10, the Member State shall ensure that the provi-sional authorisation is cancelled.
In cases where evaluation of dossiers for the purposes of inclusion of
an active substance in Annex I or IA is not completed when the periodof three years expires, the competent authority may further provision-
ally authorise the product for a period not exceeding one year,
providing there are good reasons to believe the active substance willsatisfy the requirements of Article 10. Member States shall informother Member States and the Commission of such action.
Article 16
Transitionalmeasures
1. By way of further derogating from Articles 3(1), 5(1), 8(2) and
8(4), and without prejudice to paragraphs 2 and 3, a Member Statemay, for a period of 10 years from the date referred to in Article34(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 on the market in its territory of a
biocidal product containing active substances not listed in Annex I orIA for that product type. Such active substances must be on the marketon the date referred to in Article 34(1) as active substances of abiocidal product for purposes other than those defined in Article
2(2)(c) and (d).
2. Following the adoption of this Directive, the Commission shall
commence at 10-year programme of work for the systematic examina-
tion of all active substances already on the market on the date referredto in Article 34(1) as active substances of a biocidal product forpurposes other than those defined in Article 2(2)(c) and (d). A Regula-tion, adopted according to the procedure laid down in Article 28(3),
will provide for all provisions necessary for the establishment and
implementation of the programme including the setting of prioritiesfor the evaluation of the different active substances and a timetable.No later than two years before completion of the work programme,the Commission shall forward to the European Parliament and theCouncil a report on the progress achieved with the programme.1998L0008 — EN — 20.11.2003 — 001.001 — 21
▼B
During that 10-year period and from the date referred to in Article
34(1), it may be decided pursuant to the procedure laid down in Article28(3) that an active substance shall be included in Annexes I, IA or IB
and under which conditions, or, in cases where the requirements of
Article 10 are not satisfied or the requisite information and data havenot been submitted within the prescribed period, that such activesubstance shall 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, Member States shall ensure thatauthorisations or, where relevant, registrations for biocidal productscontaining the active substances and complying with the provisions of
this Directive are granted, modified or cancelled as appropriate.
4. Where, following a review of an active substance, it is concluded
that the substance does not meet the requirements of Article 10 andconsequently cannot be included in Annex I, IA or IB, the Commission
shall bring forward proposals for restricting the marketing and use of
that substance in accordance with Directive 76/769/EEC.
5. The provisions of Council Directive 83/189/EEC of 28 March
1983 laying down a procedure for the provision of information in the
field of technical standards and Regulations (
1) shall continue to apply
during the transitional period referred to in paragraph 2.
Article 17
Researchanddevelopment
1. By way of derogation from Article 3, Member States shall
prescribe that any experiment or test for the purposes of research ordevelopment involving the placing on the market of an unauthorizedbiocidal product or an active substance intended exclusively for use ina biocidal product shall not take place unless:
(a) in the case of scientific research and development, the persons
concerned draw upand maintain written records detailing the iden-tity of the biocidal product or active substance, labelling data,quantities supplied and the names and addresses of those persons
receiving the biocidal product or active substance and compile a
dossier containing all available data on possible effects on humanor animal health or impact on the environment. This informationshall, if requested, be made available to the competent authority,
(b) in the case of process-oriented research and development, the infor-
mation required in (a) is notified to the competent authority whereand before placing on the market occurs and to the competent
authority of the Member State where the experiment or test is to
be conducted.
2. Member States shall prescribe that an unauthorised biocidal
product or an active substance for exclusive use in a biocidal product
may not be placed on the market for the purpose of any experiment ortest which may involve, or result in, release into the environmentunless the competent authority has assessed the available data andissued an authorisation for this purpose which limits the quantities to
be used and the areas to be treated and may impose further conditions.
3. Where any experiment or test takes place in a Member State other
than the Member State where placing on the market occurs, the appli-cant shall obtain experiments or tests authorisation from the competent
authority of the Member State in the territory of which the 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 on human or animal health or to have
an unacceptable adverse influence on the environment, the MemberState concerned may either prohibit them or only allow them subject1998L0008 — EN — 20.11.2003 — 001.001 — 22
(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).
▼B
to such conditions as it considers necessary to prevent those conse-
quences.
4. Paragraph 2 shall not apply if the Member State has granted the
person concerned the right to undertake certain experiments and testsand has determined the conditions under which the experiments andtests have to be undertaken.
5. Common conditions for the application of this Article, in parti-
cular the maximum quantities of active substances or biocidalproducts that may be released during experiments, and the minimumdata to be submitted in accordance with paragraph 2, shall be adoptedin accordance with the procedure laid down in Article 28(2).
Article 18
Informationexchange
1. Within a period of one month from the end of each quarter,
Member States shall inform each other and the Commission of any
biocidal products which have been authorised or registered within theirterritory or for which 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 each dangerous substance in the
meaning of Article 2(2) of Directive 67/548/EEC and their classifi-
cation;
(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 an authorisation;
(h) an indication of whether the product is of a special type (e.g.
within a frame-formulation, low-risk biocidal 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 are incomplete, it shall immediately communi-cate its concerns to the competent authority responsible for theevaluation of the dossiers and shall without undue delay inform theCommission and other Member States of its concerns.
3. Each Member State shall draw upan annual list of the biocidal
products authorised or registered in its territory and shall communicatethat list to the other Member States and the Commission.
4. In accordance with the procedure laid down in Article 28(2), a
standardised information system shall be set up to facilitate the applica-tion of paragraphs 1 and 2.
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 and
commodity substances) seven years after the date mentioned in Article34(1). The Commission shall submit the report to the Council, accom-panied by proposals if necessary.
Article 19
Confidentiality
1. Without prejudice to Council Directive 90/313/EEC of 7 June
1990 on the freedom of access to information on the environment (
1),1998L0008 — EN — 20.11.2003 — 001.001 — 23
(1) OJ L 158, 6.10.1990, p. 40.
▼B
an applicant may indicate to the competent authority the information
which he considers to be commercially sensitive and disclosure ofwhich might harm him industrially or commercially and which he
therefore wishes to be kept confidential from all persons other than
the competent authorities and the Commission. Full justification willbe required in each case. Without prejudice to the information referredto in paragraph 3 and the provisions of Directives 67/548/EEC and 88/379/EEC, Member States shall take the necessary steps to ensure the
confidentiality of the full composition of product formulations if
requested by the applicant.
2. The competent authority receiving the application shall decide, on
the basis of documentary evidence produced by the applicant, whichinformation shall be confidential within the terms of paragraph 1.
Information accepted as being confidential by the receiving competent
authority shall be treated as being confidential by the other competentauthorities, Member States 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 of the biocidal product;
(e) the names of other substances which are regarded as dangerous
within the meaning of Directive 67/548/EEC and contribute to
the classification of the 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 or product's efficacy and effects onhumans, animals and the environment and, where applicable, itsability to promote resistance;
(i) recommended methods and precautions to reduce dangers from
handling, storage, transport and use as well as from fire or otherhazards;
(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 disclose previously confidential informa-tion, the competent authority shall be informed accordingly.
4. The detailed provisions and format for making information
publicly available and for implementing this Article shall be decided
in accordance with the procedures set out in Article 28(2).
Article 20
Classification,packagingandlabellingofbiocidalproducts
1. Biocidal products shall be classified in accordance with the provi-
sions relating to classification in Directive 88/379/EEC.1998L0008 — EN — 20.11.2003 — 001.001 — 24
▼B
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 the likelihood of such a mistakebeing made;
(b) products available to the general public which may be mistaken for
food, drink or feedingstuff shall contain components to discouragetheir consumption.
3. Biocidal products shall be labelled in accordance with the provi-
sions relating to labelling in Directive 88/379/EEC. Labels shall not be
misleading or give an exaggerated impression of the product and, inany case, not mention the indications ‘low-risk biocidal product’,‘non-toxic’, ‘harmless’ or similar indications. In addition, the labelmust 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 the terms 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 instruc-
tions before use’;
(h) directions for safe disposal of the biocidal product and its packa-
ging, including, where relevant, any prohibition on reuse ofpackaging;
(i) the formulation batch number or designation and the expiry date
relevant to normal conditions of storage;
(j) the period of time needed for the biocidal effect, the interval to be
observed between applications of the biocidal product or betweenapplication and the next use of the product treated, or the nextaccess by man or animals to the area where the biocidal producthas been used, including particulars concerning decontaminationmeans and measures and duration of necessary ventilation of
treated areas; particulars for adequate cleaning of equipment; parti-
culars concerning precautionary measures during use, storage andtransport (e.g. personal protective clothing and equipment,measures for protection against fire, covering of furniture, removalof food and feedingstuff and directions to prevent animals from
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 protection of non-target organisms and avoidance ofcontamination of water;
(m) for microbiological biocidal products, labelling requirements
according to Council Directive 90/679/EEC of 26 November1990 on the protection of workers from risks related to exposureto biological agents at work(
1).
Member States shall require that items 3(a), (b), (d) and where applic-
able (g) and (k) always be carried on the label of the product.1998L0008 — EN — 20.11.2003 — 001.001 — 25
(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).
▼B
Member States shall permit items 3(c), (e), (f), (h), (i), (j) and (l) to be
carried elsewhere on the packaging or on an accompanying leaflet inte-gral to the packaging. These items of information shall be regarded as
label information for the purposes of this Directive.
4. Where a biocidal product identified as insecticide, acaricide,
rodenticide, avicide or molluscicide is authorised pursuant to this
Directive and is also subject to classification, packaging and labellingaccording to Council Directive 78/631/EEC of 26 June 1978 on theapproximation of the laws of the Member States relating to the classi-fication, packaging and labelling of dangerous preparations(pesticides) (
1) by virtue of other Community provisions, Member
States shall permit changes to the packaging and labelling of that
product which may be required as a consequence of those provisionsin so far as they do not conflict with the conditions of an authorisationissued under this Directive.
5. Member States may require the provision of samples, models or
drafts of the packaging, labelling and leaflets.
6. Member States shall make the placing of biocidal products on the
market in their territories subject to them being labelled in theirnational language or languages.
Article 21
Safety-datasheets
Member States shall take the necessary measures to ensure that a
system of specific information is established to enable professional
and industrial users and, as appropriate, other users of biocidal products
to take the necessary measures for the protection of the environmentand health as well as health and safety at the workplace. This shall bedone in the form of a safety-data sheet provided by those responsiblefor the placing on the market 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 of Article 27 of Directive 67/548/EEC.
Article 22
Advertising
1. Member States shall require that every advertisement for a
biocidal product is accompanied by the sentences ‘Use biocides safely.
Always read the label and 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 sentences with an accurate description of
the product-type being advertised, 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 manner which is misleadingin respect of the risks from the product to man or the environment.
Under no circumstances may the advertising of a biocidal product
mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or anysimilar indications.1998L0008 — EN — 20.11.2003 — 001.001 — 26
(1) 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).
▼B
Article 23
Poisoncontrol
Member States shall appoint a body or bodies responsible for receiving
information on biocidal products which have been placed on themarket, including information on the chemical composition of suchproducts, and for making such information available in cases where
suspected poisoning arises from biocidal products. Such information
may only be used to meet any medical demand by formulating preven-tive and curative measures, in particular in emergencies. MemberStates shall ensure that the information is not used for other purposes.
Member States shall take the necessary steps to ensure that the
appointed bodies provide all the requisite guarantees for maintainingthe confidentiality of the information received. Member States shallensure that the appointed bodies have at their disposal all the informa-
tion required to carry out the tasks for which they are responsible from
the manufacturers or persons responsible for marketing.
For biocidal products already on the market on the date referred to in
Article 34(1), Member States shall take measures to comply with thisArticle within three years of the date referred to Article 34(1).
Article 24
Compliancewithrequirements
Member States shall take the necessary arrangements for biocidal
products which have been placed on the market to be monitored to
establish whether they comply with the requirements of this Directive.
Every three years after the date referred to in Article 34(1), Member
States shall forward to the Commission by 30 November of the thirdyear a report on their action in these matters together with informationon any poisonings involving biocidal products. The Commission shallwithin one year of receipt of this information prepare and publish acomposite report.
Article 25
Charges
Member States shall establish systems obliging those having placed or
seeking to place biocidal products on the market and those supportingentries for active substances on Annexes I, IA or IB to pay charges,corresponding as far as possible to their costs in carrying out all the
different procedures associated with the provisions of this Directive.
Article 26
Competentauthorities
1. Member States shall designate a competent authority or compe-
tent authorities responsible for carrying out the duties imposed onMember States pursuant to this Directive.
2. Member States shall inform the Commission of the identity of
their competent authority or competent authorities, not later than thedate referred to in Article 34(1).
Article 27
Commissionprocedures
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 toArticle 10(5), or
(b) a proposal to refuse an authorisation or a registration and an expla-
natory document in accordance with Article 4(4),1998L0008 — EN — 20.11.2003 — 001.001 — 27
▼B
it shall allow a period of 90 days during which other Member States
and the applicant may submit comments to 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, unless a favourable decision is
envisaged.
Article 28
Committeesandprocedures
1. The Commission shall be assisted by a Standing Committee on
Biocidal Products (hereinafter referred to as ‘the Committee’).
The Standing Committee shall adopt its rules of procedure.
2. For matters referred to the Standing Committee by virtue of Arti-
cles 4, 11(3), 15, 17, 18, 19, 27(1)(b), 29 and 33 and for thecompilation of specific data by product type referred to in Annex V,
to be drawn from Annexes III A and III B and, as appropriate, from
Annexes IV A and IV B, Articles 4 and 7 of Decision 1999/468/EC (
1) shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 4(3) of Decision 1999/468/EC shall be
set at three months.
3. For matters referred to the Standing Committee by virtue of Arti-
cles 10, 11(4), 16, 27(1)(a) and (2), and 32, Articles 5 and 7 ofDecision 1999/468/EC shall apply, having regard to the provisions ofArticle 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
Article 29
Adaptationtotechnical progress
The amendments necessary for adapting Annexes IIA, IIB, IIIA, IIIB,
IVA and IVB, the descriptions of the product-types in Annex V to
technical progress and for specifying data requirements for each of
these product types, shall be adopted in accordance with the procedurelaid down in Article 28(2).
Article 30
Modification oradaptationofAnnexesVandVI
Acting on a proposal from the Commission, the Council and the
European Parliament shall, in accordance with the procedures laiddown in the Treaty, modify or adapt to technical progress the titles ofthe product-types of Annex V and the provisions of Annex VI.1998L0008 — EN — 20.11.2003 — 001.001 — 28
(1) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).▼M1
▼B
▼B
Article 31
Civilandcriminal liability
The granting of authorisation and all other measures in conformity with
this Directive shall be without prejudice to general civil and criminal
liability in the Member States of the manufacturer and, where applic-
able, of the person responsible for placing the biocidal product on themarket or using it.
Article 32
Safeguardclause
Where a Member State has valid reasons to consider that a biocidal
product which it has authorised, registered or is bound to authorise orregister pursuant to Articles 3 or 4, constitutes an unacceptable risk tohuman or animal health or the environment, it may provisionallyrestrict or prohibit the use or sale of that product on its territory. It
shall immediately inform the Commission and the other Member States
of such action and give reasons for its decision. A decision shall betaken on the matter within 90 days in accordance with the procedurelaid down in Article 28(3).
Article 33
Technicalnotesforguidance
The Commission, in accordance with the procedure laid down in
Article 28(2), shall draw uptechnical notes for guidance to facilitatethe day-to-day implementation of this Directive.
These technical notes shall be published in the ‘C’ series of the Official
Journalofthe EuropeanCommunities .
Article 34
ImplementationoftheDirective
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive notlater than 24 months after its entry into force. They shall forthwithinform the Commission thereof.
2. When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such referenceon the occasion of their official publication. The methods of making
such a reference shall be laid down by the Member States.
3. Member States shall communicate to the Commission the texts of
the provisions of national law which they adopt in the field covered bythis 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.1998L0008 — EN — 20.11.2003 — 001.001 — 29
▼B
ANNEX I
LISTOFACTIVESUBSTANCESWITHREQUIREMENTSAGREEDAT
COMMUNITYLEVELFORINCLUSIONINBIOCIDALPRODUCTS1998L0008 — EN — 20.11.2003 — 001.001 — 30
▼B
ANNEX IA
LISTOFACTIVESUBSTANCESWITHREQUIREMENTSAGREEDAT
COMMUNITY LEVEL FORINCLUSION IN LOW-R ISK BIOCIDAL
PRODUCTS1998L0008 — EN — 20.11.2003 — 001.001 — 31
▼B
ANNEX IB
LIST OF BASIC SUBSTANCES WITH REQUIREMENTS AGREED AT
COMMUNITYLEVEL1998L0008 — EN — 20.11.2003 — 001.001 — 32
▼B
ANNEX IIA
COMMONCOREDATASETFORACTIVESUBSTANCES
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 line with technical develop-
ment.
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 to supply the informa-
tion. In such cases a justification, acceptable to the competent authority must
be submitted. Such a justification may be the existence of a frame-formula-
tion to which the applicant has the right of access.
Dossierrequirements
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 synonyms
2.2. 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
substance
2.7. Specification of purity of the active substance in g/kg or g/l, as appro-
priate
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 (*).1998L0008 — EN — 20.11.2003 — 001.001 — 33
(*) OJ L 154, 5.6.1992, p. 1.
▼B
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
products
3.9. Flash-point3.10. Surface tension
3.11. Explosive properties
3.12. 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 determi-
nation 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 to Council Directive
80/778/EEC of 15 July 1980 relating to the quality of water
intended for human consumption (*) can be estimated with
adequate reliability at the MAC specified in that Directive for indi-
vidual pesticides
(d) Animal and human body fluids and tissues
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
protected
5.3. Effects on target organisms, and likely concentration at which the
active substance will be used
5.4. Mode of action (including time delay)5.5. Field of use envisaged5.6. User: industrial, professional, general public (non-professional)5.7. Information on the occurrence or possible occurrence of the develop-
ment 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 toxicity1998L0008 — EN — 20.11.2003 — 001.001 — 34
(*) 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).
▼B
For studies 6.1.1 to 6.1.3, substances other than gases shall be adminis-
tered via at least two routes, one of which should be the oral route. The
choice of the second route will depend on the nature of the substance
and the likely route of human exposure. Gases and volatile liquids
should be 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 more appropriate
6.3. Short-term repeated dose toxicity (28 days)
This study is not required when a sub-chronic toxicity study is avail-
able in a rodent
6.4. Subchronic toxicity 90-day study, two species, one rodent and one non-
rodent
6.5. Chronic toxicity (4)
One rodent and one other mammalian species
6.6. Mutagenicity studies6.6.1.In-vitrogene mutation study in bacteria
6.6.2.In-vitrocytogenicity study in mammalian cells
6.6.3.In-vitrogene mutation assay in mammalian cells
6.6.4. If positive in 6.6.1, 6.6.2 or 6.6.3, then an in-vivomutagenicity 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-vitrotests then undertake a second
in-vivostudy to examine whether mutagenicity or evidence of DNA
damage can be demonstrated in tissue other than bone marrow
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 form6.9.1. Medical surveillance data on manufacturing plant personnel if available6.9.2. Direct observation, e.g. clinical cases, poisoning incidents if available6.9.3. Health records, both from industry and any other available sources6.9.4. Epidemiological studies on the general population, if available
6.9.5. Diagnosis of poisoning including specific signs of poisoning and clin-
ical tests, if available
6.9.6. 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 poisoning6.10. Summary of mammalian toxicology and conclusions, including no
observed adverse effect level (NOAEL), no observed effect level1998L0008 — EN — 20.11.2003 — 001.001 — 35
▼B
(NOEL), overall evaluation with regard to all toxicological data and
any other information concerning the active substances. Where possible
any suggested worker protection measures should be included in
summary form
VII. ECOTOXICOLOGICAL STUDIES
7.1. Acute toxicity to fish
7.2. Acute toxicity to Daphniamagna
7.3. Growth inhibition test on algae
7.4. Inhibition to microbiological activity
7.5. Bioconcentration
Fate and behaviour in the environment
7.6. Degradation
7.6.1. Biotic
7.6.1.1. Ready biodegradability
7.6.1.2. Inherent biodegradability, where appropriate
7.6.2. Abiotic
7.6.2.1. Hydrolysis as a function of pH and identification of breakdown
products
7.6.2.2. 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.2 paragraph 2.2
7.8. Summary of ecotoxicological effects and fate and behaviour in the
environment
VIII. MEASURES NECESSARY TO PROTECT MAN, ANIMALS AND THE
ENVIRONMENT
8.1. Recommended methods and precautions concerning handling, use,
storage, transport or fire
8.2. In case of fire, nature of reaction products, combustion gases, etc.
8.3. Emergency measures in case of an accident
8.4. 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 recycling
8.5.2. Possibility of neutralisation of effects
8.5.3. Conditions for controlled discharge including leachate qualities on
disposal
8.5.4. Conditions for controlled incineration
8.6. Observations on undesirable or unintended side-effects, e.g. on benefi-
cial 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 danger
Risk phrases
Safety phrases1998L0008 — EN — 20.11.2003 — 001.001 — 36
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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 specifica-
tion.
(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 unneces-
sary, that claim must be fully justified.1998L0008 — EN — 20.11.2003 — 001.001 — 37
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ANNEX IIB
COMMONCOREDATASETFORBIOCIDALPRODUCTS
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 line with technical develop-
ment.
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 to supply the informa-
tion. In such cases a justification, acceptable to the competent authority must
be submitted. Such a justification may be the existence of a frame-formula-
tion to which the applicant has the right of access.
3. Information may be derived from existing data where a justification accep-
table to the competent authority is provided. In particular, the provisions of
Directive 88/379/EEC should be used wherever possible to minimise animal
testing.
Dossierrequirements
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, solution
III. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES
3.1. Appearance (physical state, colour)3.2. Explosive properties
3.3. Oxidising properties
3.4. Flash-point and other indications of flammability or spontaneous igni-
tion
3.5. Acidity/alkalinity and if necessary pH value (1 % in water)3.6. Relative density1998L0008 — EN — 20.11.2003 — 001.001 — 38
▼B
3.7. Storage stability — stability and shelf-life. Effects of light, temperature
and humidity on technical characteristics of the biocidal product; reac-
tivity 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 the
biocidal 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 and animals
5.5. Function, e.g. fungicide, rodenticide, insecticide, bactericide
5.6. Pest organism(s) to be controlled and products, organisms or objects to
be protected
5.7. Effects on target organisms
5.8. Mode of action (including time delay) in so far as not covered by
Annex IIA, paragraph 5.4
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, labora-
tory 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 the nature of the
product and the likely route of human exposure. Gases and volatile
liquids should be administered by the inhalation route
6.1.1. Oral6.1.2. Dermal
6.1.3. Inhalation
6.1.4. 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 eye irritation, as appro-
priate1998L0008 — EN — 20.11.2003 — 001.001 — 39
▼B
6.2. Skin and eye irritation (1)
6.3. Skin sensitisation
6.4. 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
envisaged
7.2. 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 fire
8.2. Specific treatment in case of an accident, e.g. first-aid measures, anti-
dotes, 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 equipment8.4. Identity of relevant combustion products in cases of fire8.5. 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 or recycling, 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 benefi-
cial 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 organ-
isms
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 included1998L0008 — EN — 20.11.2003 — 001.001 — 40
▼B
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.1998L0008 — EN — 20.11.2003 — 001.001 — 41
▼B
ANNEXIIIA
ADDITIONALDATASETFORACTIVESUBSTANCES
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 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 to supply
the information. In such cases a justification, acceptable to the competent
authority must be submitted. Such a justification may be the existence of a
frame-formulation to which the applicant has the 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 rele-
vant breakdown products (2)
IV. ANALYTICAL METHODS FOR DETECTION AND IDENTIFICATION
1. Analytical methods including recovery rates and the limits of determina-
tion 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 prop-
erties then neurotoxicity studies will be required. The test species 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 for response to reactivating agents
should be considered
2. Toxic effects on livestock and pets
3. 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 feeding-
stuff for livestock is prepared, consumed or stored the tests 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 be required
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 shall be required
7. Mechanistic study — any studies necessary to clarify effects reported in
toxicity studies
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 treat-
ment then the test described in Section XIII, part 4.1 shall be required
4. Any other biodegradability tests that are relevant from the results in para-
graphs 7.6.1.1 and 7.6.1.2 of Annex IIA1998L0008 — EN — 20.11.2003 — 001.001 — 42
▼B
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 tests described 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 dangerous substances(*)
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 specifica-
tion.
XI. FURTHER HUMAN HEALTH-RELATED STUDIES
1. Food and feedingstuffs studies
1.1. 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 of disappearance
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 or animal 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 of animal 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 acceptability
1.8. Any other available information that is relevant
1.9. Summary and evaluation of data submitted under 1.1 to 1.82. 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 ENVIR-
ONMENT
1. Fate and behaviour in soil
1.1. 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 meta-
bolites and degradation products
1.4. Extent and nature of bound residues2. 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 products1998L0008 — EN — 20.11.2003 — 001.001 — 43
(*) OJ L 20, 26.1.1980, p. 43.
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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 informa-
tion indicates that this is relevant, then the rate and route 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 birds
1.1. 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 fish
2.4.Daphniamagna reproduction and growth rate
3. Effects on other non-target organisms
3.1. Acute toxicity to honeybees and other beneficial arthropods, e.g. preda-
tors. 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 41998L0008 — EN — 20.11.2003 — 001.001 — 44
▼B
ANNEXIIIB
ADDITIONALDATASETFORBIOCIDALPRODUCTS
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 line with tech-
nical 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 to supply
the information. In such cases a justification, acceptable to the competent
authority must be submitted. Such a justification may be the existence of
a frame-formulation to which the applicant has the right of access.
3. Information may be derived from existing data where a justification
acceptable to the competent authority is provided. In particular, the provi-
sions of Directive 88/379/EEC should be used wherever possible to
minimise animal testing.
XI. FURTHER HUMAN HEALTH-RELATED STUDIES
1. Food and feedingstuffs studies
1.1. If residues of the biocidal product remain on feedingstuffs for a signifi-
cant period of time, then feeding and metabolism studies in livestock
shall be required to permit evaluation of residues in food of 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 ENVIR-
ONMENT
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 VII
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 toxi-
cologically 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 honeybees1998L0008 — EN — 20.11.2003 — 001.001 — 45
▼B
3.3. Effects on beneficial arthropods other than bees
3.4. Effects on earthworms and other soil non-target macro-organisms,
believed to be at risk
3.5. Effects on soil non-target micro-organisms
3.6. Effects on any other specific, non-target organisms (flora and fauna)
believed to be at risk
3.7. 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
conditions
3.7.2. 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 31998L0008 — EN — 20.11.2003 — 001.001 — 46
▼B
ANNEXIVA
DATASETFORACTIVESUBSTANCES
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 be in 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 to supply the informa-
tion. In such cases, a justification, acceptable to the competent authority must
be submitted. Such a justification may be the existence of a frame-formula-
tion to which the applicant has the right of access.
Dossierrequirements
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 environ-
ment
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 deposited2.4. Methods, procedures and criteria used to establish the presence and
identity of the organism (e.g. morphology, biochemistry, serology, etc.)
III. SOURCE OF THE ORGANISM
3.1. Occurrence in nature or otherwise3.2. Isolation methods for organism or active strain3.3. Culture methods
3.4. 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 on production
and isolation, together with all known differences between the mutant
strains and parent and naturally occurring strains1998L0008 — EN — 20.11.2003 — 001.001 — 47
▼B
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 stock
3.7. 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 ºC and other rele-
vant 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, where relevant
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 organisms
5.3. 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 informa-
tion on presence, absence or production of toxins with, if appropriate,
information on their nature, identity, chemical structure and 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
used
5.8. Infectivity and physical stability when properly used5.9. Genetic stability under environmental conditions of proposed use
5.10. Any pathogenicity and infectivity to man and animals under conditions
of immunosuppression
5.11. 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 develop-
ment 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 toxicity1998L0008 — EN — 20.11.2003 — 001.001 — 48
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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. oral
2. dermal
3. inhalation
4. skin and where necessary eye irritation
5. skin sensitisation and, where necessary, respiratory sensitisation and
6. 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 administration
2. other routes (inhalation, dermal) as appropriate and
3. 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 7.3. One rodent and one other
mammal
7.5. Mutagenicity studies
As specified in Annex IIA, Section VI, part 6.6
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) distribu-
tion and excretion in mammals including elucidation of metabolic
pathways
7.8. Neurotoxicity studies: required where there is any indication of antic-
holinerterase activity or other neurotoxic effects. Delayed neurotoxicity
tests using adult hens should be performed where appropriate
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, livestock or 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 data
5. Poisoning diagnosis (signs, symptoms) including details of any
analytical tests
6. 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 any
other information concerning the active organism. Where possible
suggested user protection measures should be included in summary
form1998L0008 — EN — 20.11.2003 — 001.001 — 49
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VIII. ECOTOXICOLOGICAL STUDIES
8.1. Acute toxicity to fish
8.2. Acute toxicity to Daphniamagna
8.3. Effects on algae growth (inhibition test)
8.4. Acute toxicity on one other, non-aquatic, non-target organism
8.5. 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 fauna8.8. 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 water
8.10. In cases where toxins are produced, data as outlined in Annex IIA,
Section VII, parts 7.6 to 7.8
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 this
9.4. Consequences of the contamination of air, soil and water, particularly
drinking water
9.5. Emergency measures in case of accident
9.6. Procedures for waste management of the active organism including
leachate qualities on disposal
9.7. 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 the bioha-
zard sign specified in Annex II to Directive 90/679/EEC
XI. SUMMARY AND EVALUATION OF SECTIONS II TO X1998L0008 — EN — 20.11.2003 — 001.001 — 50
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ANNEXIVB
DATASETFORBIOCIDALPRODUCTS
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 line with technical develop-
ment.
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 to supply the informa-
tion. In such cases, a justification, acceptable to the competent authority must
be submitted. Such a justification may be the existence of a frame-formula-
tion to which the applicant has the right of access.
3. Information may be derived from existing data where a justification accep-
table to the competent authority is provided. In particular, the provisions of
Directive 88/379/EEC should be used wherever possible to minimise animal
testing.
Dossierrequirements
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.)
2.3. Physical state and nature of the biocidal product (emulsifiable concen-
trate, 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 stability
3.4. Technical characteristics of the biocidal product3.4.1. Wettability1998L0008 — EN — 20.11.2003 — 001.001 — 51
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3.4.2. Persistent foaming
3.4.3. Suspensibility and suspension stability3.4.4. Wet sieve test and dry sieve test
3.4.5. Particle size distribution, content of dust/fines, attrition and friability
3.4.6. 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
1m m
3.4.7. Content of active substance in or on bait particles, granules or treated
material
3.4.8. Emulsifiability, re-emulsifiability, emulsion stability3.4.9. Flowability, pourability and dustability3.5. 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 application
3.7. 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
product
4.2. 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.)
5.3. Application rate5.4. Where necessary, in the light of the test results, any specific circum-
stances or environmental conditions under which the product may or
may not be used
5.5. Method of application
5.6. 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 resis-
tance
5.11. Effects on the quality of materials or products treated
VI. TOXICITY INFORMATION ADDITIONAL TO THAT REQUIRED FOR
THE ACTIVE ORGANISM
6.1. Oral single dose
6.2. Percutaneous single dose
6.3. Inhalation6.4. Skin and where relevant eye irritation
6.5. Skin sensitisation1998L0008 — EN — 20.11.2003 — 001.001 — 52
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6.6. Available toxicological data relating to non-active substances
6.7. Operator exposure
6.7.1. Percutaneous absorption/inhalation depending on formulation and
method of application
6.7.2. Likely operator exposure under field conditions, including where rele-
vant 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 environ-
ment
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 use
8.2. Re-entry periods, necessary waiting periods or other precautions to
protect humans and animals
8.3. Emergency measures in case of an accident8.4. Procedures for destruction or decontamination of the biocidal product
and its packaging
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 accor-
dance 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 groupas outlined in Article 2(d) of Directive 90/679/EEC
together with the biohazard sign specified in that Directive if appro-
priate
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 IX1998L0008 — EN — 20.11.2003 — 001.001 — 53
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ANNEX V
BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS
REFERREDTOINARTICLE2(1)(a)OFTHISDIRECTIVE
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 products used as algaecides.
Usage areas include, inter alia, swimming pools, aquariums, bathing and other
waters; air-conditioning systems; walls and floors in health and other institu-
tions; chemical toilets, waste water, hospital waste, soil or other substrates (in
playgrounds).
Product-type 3: Veterinary hygiene biocidal products
Products in this groupare biocidal p roducts 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 uten-
sils, surfaces or pipework associated with the production, transport, storage or
consumption of food, feed or drink (including drinking water) 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: PreservativesProduct-type 6: In-can preservatives
Products used for the preservation of manufactured products, other than food-
stuffs 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 micro-
bial deterioration in order to protect the initial properties of the surface of
materials or objects such as paints, plastics, sealants, wall adhesives, binders,
papers, art works.
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 micro-
biological deterioration.1998L0008 — EN — 20.11.2003 — 001.001 — 54
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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, equip-
ment 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 arthro-
pods
Products used for the control of arthropods (e.g. insects, arachnids and crusta-
ceans).
Product-type 19: Repellents and attractants
Products used to control harmful organisms (invertebrates such as fleas, verte-
brates such as birds), by repelling or attracting, including those that are used
for human or veterinary hygiene either directly or indirectly.
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.1998L0008 — EN — 20.11.2003 — 001.001 — 55
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Product-type 23: Control of other vertebrates
Products used for the control of vermin.1998L0008 — EN — 20.11.2003 — 001.001 — 56
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ANNEX VI
COMMON PRINCIPLES FOR THE EVALUATIONOF DOSSIERSFOR
BIOCIDALPRODUCTS
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 integrationofconclusionsDEFINITIONS(a)Hazardidentification
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 relationshipbetween the dose, or level of exp o-
sure, of an active substance or substance of concern in a biocidal product
and the incidence and severity of an effect.
(c)Exposureassessment
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 estimate the concentration/
doses to which human populations, animals or environmental compartments
are or may be exposed.
(d)Riskcharacterisation
This is the estimation of the incidence and severity of the adverse effects
likely to occur in a human population, animals or environmental compart-
ments due to actual or predicted exposure to any active substance or
substance of concern in a biocidal product. This may include ‘risk estima-
tion’ i.e. the quantification of that likelihood.
(e)Environment
Water, including sediment, air, land, wild species of fauna and flora, and
any interrelationshipbetween them, as well as any relationshipwith living
organisms.1998L0008 — EN — 20.11.2003 — 001.001 — 57
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INTRODUCTION
1. This Annex lays down principles to ensure that evaluations made and deci-
sions taken by a Member State concerning the authorisation of a biocidal
product providing it is a chemical preparation results in a harmonised high
level of protection for humans, animals and the environment in accordance
with Article 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 a risk assessment shall
be carried out to determine the acceptability or otherwise of any risks iden-
tified during the proposed normal use of the biocidal product. This is done
by carrying out an assessment of the risks associated with the relevant indi-
vidual 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 risk assessment shall entail
hazard identification, and, as appropriate, dose (concentration) — response
(effect) assessment, exposure assessment and risk characterisation. Where a
quantitative risk assessment cannot 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 biocidal product.
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 product type and asso-
ciated risks. The data required shall be the minimum necessary to carry out
an appropriate risk assessment. Member States should take due considera-
tion of the requirements of Articles 12 and 13 of this Directive in order to
avoid duplication of data submissions. The minimum set of data required
for an active substance in any biocidal product type, however, shall be that
detailed in Annex VIIA to Directive 67/548/EEC; these data will already
have been submitted and assessed as part of the risk assessment required
for entry of the active substance into Annex I, IA or IB to this Directive.
Data may also be required on a substance of concern present in a biocidal
product.
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 biocidal product 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 recogni-
tion 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 procedure as 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 authori-
sation may include restrictions on use or other conditions. In certain cases
the Member State may conclude that more data are required before an
authorisation decision can be made.
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 any additional studies
required, or to amend any proposed conditions for the use of the biocidal
product or to modify its nature or its composition in order to ensure full
compliance with the requirements of this Annex or of this Directive. The
administrative burden, especially for small and medium-sized enterprises1998L0008 — EN — 20.11.2003 — 001.001 — 58
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(SMEs), shall be kept to the minimum necessary without prejudicing the
level of protection afforded to humans, animals and the environment.
13. The judgments made by the Member State during the evaluation and deci-
sion-making process must be based on scientific principles, preferably
recognised at international level, and be made with the benefit of expert
advice.
EVALUATIONGeneral principles
14. 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 acceptance of these data the
Member State shall utilise them by carrying out a risk assessment based
on the proposed 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 assessment shall be
carried out for each of these. The risk assessment shall cover the proposed
normal use of the biocidal product together with a realistic worst-case
scenario including any relevant production and disposal 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 appropriate no-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 risk characterisation.
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 risk assessment for the
biocidal product. Where quantitative results are not available the results of
the qualitative 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 risk assessment.
Effectsonhumans
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,
— 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,1998L0008 — EN — 20.11.2003 — 001.001 — 59
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— 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 biocidal product being classified
according to the requirements of Article 20 of this Directive then dose
(concentration) — response (effect) assessment, exposure assessment and
risk characterisation shall be required.
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 been conducted but the results
have not lead to classification of the biocidal product then risk characterisa-
tion in relation to that effect shall not be necessary unless there are other
reasonable grounds for concern, e.g. adverse environmental effects or unac-
ceptable 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 asubstance of concern present in a biocidal product.
26. For repeated dose toxicity and reproductive toxicity the dose response rela-
tionshipshall be assessed for each active substance or substance of concern
and, where possible, the no-observed-adverse-effect level (NOAEL) identi-
fied. 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 acute toxicity, the LD50
(median lethal dose) or LC50 (median lethal concentration) value or, where
the fixed dose procedure has been used, the discriminating dose shall be
derived. For the other effects 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 product.
28. For mutagenicity and carcinogenicity it shall be sufficient to determine
whether the active substance or substance of concern has an inherent capa-
city 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 a carcinogen is non-genotoxic, it will be appropriate to identify
a N(L)OAEL as described in paragraph 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 a subject already sensi-
tised to a given substance, it shall be sufficient to evaluate whether the
active substance or substance of concern has an inherent capacity to cause
such effects during use of the biocidal 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 be given to those data
when carrying out the risk assessment.
31. An exposure assessment shall be carried out for each of the human popula-
tions (professional users, non-professional users and humans exposed
indirectly via the environment) for which exposure to a biocidal product
occurs or can reasonably be foreseen. The objective of the assessment shall
be to makea 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 informa-
tion is available.
33. Where adequately measured, representative exposure data are available,
special consideration shall be given to them when conducting the exposure1998L0008 — EN — 20.11.2003 — 001.001 — 60
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assessment. Where calculation methods are used for the estimation of expo-
sure 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 the dose/concentration to which
the population will be exposed. Where a NOAEL or LOAEL cannot be
established a qualitative comparison shall be made.
Effectsonanimals
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.
Effectsontheenvironment
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 the biocidal 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 biocidal product being classified
according to the requirements of this Directive then dose (concentration)
— response (effect) assessment, exposure assessment and risk characterisa-
tion 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 been conducted but the results
have not led to classification of the biocidal product then riskcharacterisa-
tion in relation to that effect shall not be necessary unless there are other
reasonable grounds for concern. Such grounds may derive from the proper-
ties and effects of any active substance or 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 not expected to occur. This shall
be carried out for the active substance and for any substance of concern
present 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 qualitative estimation 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 an assessment factor to
the values resulting from tests on organisms, e.g. LD50 (median lethal
dose), LC50 (median lethal concentration), EC50 (median effective concen-
tration), IC50 (concentration causing 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 extra-
polation from test data on a limited number of species to the real
environment. Therefore, in general, the more extensive the data and the1998L0008 — EN — 20.11.2003 — 001.001 — 61
▼B
longer the duration of the tests, the smaller is the degree of uncertainty and
the size of the assessment 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 Directive 93/67/EEC of 20 July 1993
laying down the principles for assessment of risks to man and environment
from 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 the biocidal 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 exposure then 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 any relevant contribution
from material treated with biocidal products are known or are reasonably
foreseeable.
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,
— 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 the estimation of expo-
sure levels, adequate models shall be applied. The characteristics of these
models shall be as listed in paragraph 33. Where appropriate, on a case-
by-case basis, relevant monitoring data from substances with analogous use
and exposure patterns or analogous properties should also be considered.
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 characteri-
sation shall entail a qualitative evaluation of the likelihood that an effect is
occurring under the current conditions of exposure or will occur under the
expected conditions of exposure.
Unacceptableeffects
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 evaluation of the
mechanism by which the effect is obtained and the observed effects on the
behaviour and health of the target vertebrates; where the intended effect is
to kill the target vertebrate the time necessary to obtain the death of the
target vertebrate and the conditions under which death occurs shall be eval-
uated.
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 an adverse reaction to
fastenings and fittings used in wood following the application of a wood
preservative.1998L0008 — EN — 20.11.2003 — 001.001 — 62
(*) OJ L 227, 8.9.1993, p. 9.
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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 to demonstrate the efficacy of
the biocidal product against the target organism when used normally in
accordance 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 field data 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 the results 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 of concern 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.
DECISION MAKINGGeneral principles
55. 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 substance together with
the risks from each substance of concern present in the biocidal product.
The risk assessments shall cover normal use of the biocidal product together
with a realistic worst-case scenario including any relevant disposal issue
either of the biocidal product itself or any material treated with it.
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 which application 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 informa-
tion or data are required before an authorisation decision can be made, then
the need for any such information or data shall be justified. This additional
information or data shall be the minimum necessary to carry out a further
appropriate 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, animals or the environment, are
efficacious and which contain active substances permitted at Community
level to be used in such biocidal products.
62. The Member State shall impose, where appropriate, conditions or restric-
tions 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 the1998L0008 — EN — 20.11.2003 — 001.001 — 63
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expected advantages and the risks likely to arise from the use of the
biocidal product.
63. In the decision-making process the Member State shall take into considera-
tion 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 authorisa-
tion of a biocidal product, take into account the uncertainty arising from the
variability in the data used in the evaluation and decision-making process.
65. The Member State shall prescribe that biocidal products shall be used prop-
erly. Proper use shall include application at an efficacious dose and
minimisation of use of biocidal products where possible.
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 Commu-
nity 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 and its packaging or
any other relevant material associated with the biocidal product, which
conforms to the relevant regulatory provisions.
Effectsonhumans
68. The Member State shall not authorise a biocidal product if the risk assess-
ment confirms that, in foreseeable application including a realistic worst
possible scenario, the product presents an unacceptable 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 when making a decision on
the authorisation of a biocidal product.
70. The Member State shall examine the relationshipbetween the exp osure and
the effect, and use this in the decision-making process. A number of factors
need to be considered when examining this relationshipand one of the most
important is the nature of the adverse effect of the substance. These effects
include acute toxicity, irritancy, corrosivity, sensitisation, repeated dose
toxicity, mutagenicity, carcinogenicity, neurotoxicity, reproduction toxicity
together with physico-chemical properties, and any other 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 margin of 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 authorisa-
tion, the wearing of personal protective equipment such as respirators,
breathing-masks, overalls, gloves and goggles in order to reduce exposure
for professional operators. Such equipment must be readily available to
them.
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.1998L0008 — EN — 20.11.2003 — 001.001 — 64
▼B
74. If the relationshipbetween the exp osure 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 reproduction category 1 or 2, shall be
authorised for use by the general public.
Effectsonanimals
76. The Member State shall not authorise a biocidal product if the risk assess-
ment 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 authorisation decision.
Effectsontheenvironment
78. The Member State shall not authorise a biocidal product if the risk assess-
ment confirms that the active substance, or any substance of concern, or any
degradation, or reaction product presents an unacceptable 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 variability in the data used both in measure-
ments 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 the concern or if risk
reduction measures are necessary or if the product cannot be given an
authorisation at all. Relevant factors to be considered are those previously
mentioned in paragraph 38.
Water81. 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 relevant metabolites
or breakdown or reaction products in water (or its sediments) has an unac-
ceptable impact on non-target species in the aquatic, marine or estuarine
environment unless it is scientifically demonstrated 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 relevant metabolites
or breakdown or reaction products in groundwater exceeds the lower of the
following concentrations:
(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 particular toxicological 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 rele-
vant metabolites, breakdown or reaction products to be expected in surface1998L0008 — EN — 20.11.2003 — 001.001 — 65
▼B
water or its sediments after use of the biocidal product under the proposed
conditions 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
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 proce-
dures for cleaning application equipment, must be such that the likelihood
of accidental contamination of water or its sediments is minimised.
Soil85. 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 biocidal product:
— 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.
Air86. 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 relevant field conditions
there is no unacceptable effect.
Effects onnon-targetorganisms
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 or substance 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 proposed conditions
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 assess-
ment that under field conditions no unacceptable effects occur, either
directly or indirectly, after use of the product according to the proposed
conditions of use.
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 the biocidal 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 not threatened 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 clearly established in the risk
assessment that under field conditions no unacceptable impact, either
directly or indirectly, occurs on the viability of exposed organisms
including marine and estuarine organisms after use of the biocidal
product according to the proposed conditions of use.
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 years from the date on
which this Directive enters into force if similar fouling control cannot be1998L0008 — EN — 20.11.2003 — 001.001 — 66
(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).
▼B
achieved by other practicable means. When implementing this provision,
Member States shall, if appropriate, take into 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 for any active substance,
substance of concern, relevant metabolite, breakdown or reaction product
the PEC/PNEC ratio is above 1 unless it is clearly established in the risk
assessment that under field conditions no unacceptable impact, either
directly or indirectly, occurs on the viability of such micro-organisms.
Unacceptableeffects
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 conse-
quences of this resistance. This may involve modification of the 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 unne-
cessary 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 of authorisation.
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, or to other means of control.
Where no reference products exist, the biocidal product must give a defined
level of protection or control in the areas of proposed use. Conclusions as to
the performance of the biocidal product must be valid for all areas of
proposed use and for all areas in the Member State except where the
proposed label prescribes that the biocidal product is intended for use in
specific circumstances. Member States shall evaluate dose response data
generated in trials (which must include an untreated control) involving
dose rates lower than the recommended rate, in order to assess if the recom-
mended 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 substance and the
substances of concern to produce an overall conclusion for the biocidal
product itself. A summary 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,
— 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 an overall conclusion for
the global effect of the biocidal product.
96. The Member State shall then take due consideration of any relevant unac-
ceptable effects, the efficacy of the biocidal product and the benefits of
using the biocidal product before taking an authorisation decision on the
biocidal product.1998L0008 — EN — 20.11.2003 — 001.001 — 67
▼B
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 this Annex and this
Directive.1998L0008 — EN — 20.11.2003 — 001.001 — 68