Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market - Main contents

EN

Official Journal of the European Communities

L 123/1

Whereas, in their resolution of 1 February 1993 on a Community programme of policy and action in relation to the environment and sustainable development (4), the Council and the representatives of the Governments of the Member States, meeting within the Council, approved the general approach and strategy of the programme presented by the Commission, in which the need for risk management of non-agricultural pesticides is emphasised;

Whereas, both when the eighth Amendment (5) to Council Directive 76/769/EEC of 27 July 1976, on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of dangerous 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 harmonised Community provisions for biocides, formerly known as non-agricultural pesticides, and invited the Commission to examine the situation in Member States and the possibility for action at Community level;

Whereas biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured products; whereas biocidal products can pose risks to humans, animals and the environment in a variety of ways due to their intrinsic properties and associated use patterns;

Whereas the Commission review showed differences in the regulatory situation in the Member States; whereas such differences may constitute barriers not only to trade in biocidal products but 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 rules relating to the placing on the market for use of biocidal products, taking as a condition a high level of protection for humans, animals and the environment; whereas, having regard to the principle 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 Member States; whereas a directive on biocidal products is the most appropriate way of establishing such a framework;

Whereas the framework of rules should provide that biocidal products should not be placed on the market for use unless they have complied with the relevant procedures of this Directive;

Whereas, to take account of the specific nature of some biocidal products and the risks associated with their proposed use, it is appropriate to provide for simplified authorisation procedures, including registration;

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; whereas a common core data set for active substances and for biocidal products in which they are contained is necessary so as to assist both the applicants seeking authorisation and those carrying out the evaluation to decide on the authorisation; whereas, furthermore, specific data requirements need to be elaborated for each of the product types covered by this Directive;

Whereas it is necessary, when biocidal products are being authorised, to make sure that, when properly used for the purpose intended, they are sufficiently effective and have no unacceptable 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 current scientific and technical knowledge, no unacceptable effect on the environment and, in particular, on human or animal health;

Whereas it is necessary to provide common principles for the evaluation and authorisation of biocidal products to ensure a harmonised approach by Member States;

Whereas Member States should not be prevented from imposing additional requirements on the use of biocidal products in so far as these additional requirements are in conformity with Community law and in particular do not run counter to the provisions of this 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;

Whereas, in the light of the diversity of both the active substances and the biocidal products concerned, the data and test requirements should suit the individual circumstances and result in an overall risk assessment;

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 assessing whether or not an active substance can be entered in the Community list; whereas the information that interested parties must 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, compared with each other under specific conditions, to take account of developments in science and technology;

Whereas, when due account is taken of products which pose only a low risk, their active substances should be incorporated in 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 substance and a simple diluent should be incorporated in a separate specific annex;

Whereas when an active substance is evaluated for its entry or otherwise in the relevant annexes of the Directive, it is necessary for such an evaluation to cover, where appropriate, the same aspects as those covered by the evaluation made under Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (8) and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (9) as far as the risk assessment is concerned; whereas, therefore, the risks associated with the production, use and disposal of the active substance and materials treated with it are to be considered in a similar way as they are in the aforementioned legislation;

Whereas it is in the interest of the free circulation of biocidal products, as well as of materials treated with them, that authorisation granted by one Member State should be recognised by other Member States subject to the specific conditions contained in this Directive;

Whereas, while envisaging harmonised provisions for all biocidal product types, including those intended to control vertebrates, the actual use of such types might give rise to concern; whereas therefore Member States should be allowed, subject to the Treaty, to derogate from the principle of mutual recognition for biocidal products falling under three particular types of biocides whenever intended to control particular kinds of vertebrates, in so far as such derogations are justified and do not jeopardise the purpose of this Directive;

Whereas it is therefore desirable that a system for the mutual exchange of information should be established and that Member States and the Commission should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorisation of biocidal products;

Whereas it should be possible for Member States to authorise, for a limited period of time, biocidal products which do not comply 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 Member States from authorising, for a limited period of time for use in their territory, biocidal products containing an active substance not 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 and the biocidal product satisfy the Community conditions set for them;

Whereas it is essential that this Directive help to minimise the number of tests on animals and that testing should be made dependent on the purpose and use of a product;

Whereas close coordination should be ensured with other Community legislation and in particular with Directive 91/414/EEC, the Directives concerned with the protection of water and those concerned with the contained use and deliberate release of genetically modified organisms;

Whereas the Commission is to draw up technical notes for guidance in particular on the implementation of the authorisation procedures, the entry of active substances in the appropriate Annexes, the Annexes relating to data requirements and the Annex dealing with the common principles;

Whereas, in order to ensure that the requirements laid down in respect of authorised biocidal products are satisfied when they are placed on the market, Member States should make provision for appropriate control and inspection arrangements;

Whereas the implementation of this Directive, the adaptation of its Annexes to the development of technical and scientific knowledge and the inclusion of active substances in the appropriate Annexes necessitate close cooperation between the Commission, the Member States and the applicants; whereas, in cases where the procedure of the Standing Committee on Biocidal Products is to be applied, this constitutes a suitable basis for such cooperation;

Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the EC Treaty was reached on 20 December 1994 (10);

Whereas the Commission will apply the modus vivendi to the implementing measures flowing from this Directive that it envisages adopting, including those concerning Annexes IA and IB;

Whereas, since the full implementation of this Directive, and especially 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 limitations of the marketing and use of certain active substances and products or groups thereof;

Whereas the review programme on active substances will need to take account of other work programmes within the framework of other Community legislation concerned with the review or authorisation of substances and products or relevant international Conventions;

Whereas the costs of the procedures associated with the operation of the Directive need to be recovered from those seeking to place, or placing, biocidal products on the market and from those supporting the entries of active substances in the relevant Annexes;

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 develop further rules in this area,

the authorisation and the placing on the market for use of biocidal products within the Member States;

the mutual recognition of authorisations within the Community;

the establishment at Community level of a positive list of active substances which may be used in biocidal products.

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (11),

Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States on veterinary medicinal products (12),

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 products and laying down additional provisions for immunological medicinal products (13),

Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products (14),

Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products (15),

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (16),

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (17),

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (18),

Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (19), Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (20) and European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (21),

Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (22),

Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk based products (23),

Council Directive 89/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products (24),

Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (25),

Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (26),

Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (27), Council Directive 82/471/EEC of 30 June 1982 on certain products used in animal nutrition (28) and Council Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs (29),

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (30),

Council Directive 95/5/EC of 27 February 1995 amending Directive 92/120/EEC on the conditions for granting temporary and limited derogations from specific Community health rules on the production and marketing of certain products of animal origin (31),

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (32).

Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (33),

Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (34),

Council Regulation (EEC) No 2455/92 of 23 July 1992 concerning the export and import of certain dangerous chemicals ( (35)),

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 (36), Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (37) and individual Directives based on these Directives,

Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations or administrative provisions of the Member States concerning misleading advertising (38).

Biocidal products

Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, 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.

Low-risk biocidal product

A biocidal product which contains as active substance(s) only one or more of those listed in Annex IA and which does not contain any substance(s) of concern.

Under the conditions of use, the biocidal product shall pose only a low risk to humans, animals and the environment.

Basic substance

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 directly or in a product consisting of the substance and a simple diluent which 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 accordance with the procedure laid down in Articles 10 and 11, are inter alia the following:

Active substance

A substance or micro-organism including a virus or a fungus having general or specific action oh or against harmful organisms.

Substance of concern

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 biocidal product in sufficient concentration to create such an effect.

Such a substance, unless there are other grounds for concern, would be normally a substance classified as dangerous according to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (39), and present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Article 3 of Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (40).

Harmful organism

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.

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 reaction.

Placing on the market

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. Importation of a biocidal product into the customs territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive.

Authorisation

An administrative act by which the competent authority of a Member State authorises, following an application submitted by an applicant, the placing on the market of a biocidal product in its territory or in a part thereof.

Frame-formulation

Specifications for a group of biocidal products having the same use and user type.

This group of products must contain the same active substances of the same specifications, and 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 percentage 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 its efficacy.

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 of this Directive, allows the placing on the market of a low-risk biocidal product in its territory or in a part thereof.

Letter of access

A document, signed by the owner or owners of relevant data protected under the provisions of this Directive, which states that these data may be used by the competent authority for the purpose of granting an authorisation or a registration of a biocidal product under this Directive.

substance,

preparation,

scientific research and development,

process-orientated research and development

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 and verified by the competent authorities.

Unless otherwise specified, all provisions relating to authorisation under this Directive shall also apply to registration.

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.

the target species is not present in harmful quantities,

unacceptable tolerance or resistance of the target organism to the biocidal product is demonstrated, or

the relevant circumstances of use, such as climate or breeding period of the target species, differ significantly from those in the Member State where the biocidal product was first authorised, and an unchanged authorisation may therefore present unacceptable risks to humans or the environment,

the active substance(s) included therein are listed in Annex I or IA and any requirements laid down in these Annexes are fulfilled;

it is established, in the light of current scientific and technical knowledge, and is shown from appraisal of the dossier provided for in Article 8, according to the common principles for the evaluation of dossiers as laid down in Annex VI, that, when used as authorised and having regard to:

the biocidal product:

the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities 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;

its physical and chemical properties have been determined and deemed acceptable for purposes of the appropriate use, storage and transport of the product.

the active substance is no longer included in Annex I or IA as required by Article 5(l)(a);

the conditions within the meaning of Article 5(1) for obtaining the authorisation are no longer satisfied;

it is discovered that false or misleading particulars were supplied concerning the facts on the basis of which the authorisation was granted.

a dossier or a letter of access for the biocidal product satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex IIB and, where specified, the relevant parts of Annex IIIB, and

for each active substance in the biocidal product, a dossier or a letter of access satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex IIA and, where specified, the relevant parts of Annex IIIA.

applicant:

identity of the biocidal product:

intended uses:

efficacy data,

analytical methods,

classification, packaging and labelling, including a draft label, according to Article 20,

safety data sheet prepared in accordance with Article 10 of Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous substances (41), or Article 27 of Directive 67/548/EEC.

where the active substance was not on the market before the date referred to in Article 34(1), a dossier has been forwarded to a Member 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;

it is classified, packaged and labelled in accordance with the provisions of Directive 67/548/EEC.

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),

carcinogenic,

mutagenic,

toxic for reproduction,

sensitising, or

is bioaccumulative and does not readily degrade.

requirements on:

the establishment of the following:

an applicant has forwarded to the competent authority of one of the Member States:

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, where relevant, Annexes IIIA and IIIB, accepts them and agrees to the applicant forwarding a summary of the dossiers to the Commission and the other Member States.

unless the second or subsequent applicant has the written agreement in the form of a letter of access of the first applicant that use may be made of such information, or

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 date of first inclusion in Annex I or IA, or

in the case of an active substance already on the market on the date referred to in Article 34(1):

in the case of any further information submitted for the first time for any of the following:

for a period of five years from the date of decision following receipt of further information unless the five-year period expires before 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.

unless the second or subsequent applicant has the written agreement in the form of a letter of access of the first applicant that use may be made of such information; or

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;

in the case of a biocidal product containing an active substance already on the market on the date referred to in Article 34(1);

in the case of any data submitted for the first time for either of the following:

for a period of five years from the date of first receipt of further information, unless the five-year period expires before the period in paragraphs (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.

an applicant for authorisation of biocidal products shall, before carrying out experiments involving vertebrate animals, enquire of the competent authority of the Member State to which he intends making application:

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;

the competent authority of the Member State, if satisfied that the applicant intends to apply, shall provide the name and address of the holder or holders of former relevant authorisations and shall at the time inform the holders of the authorisations of the name and address 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.

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.

the active substance satisfies the requirements of Article 10 and,

the biocidal product may be expected to satisfy the conditions of Articles 5(l)(b), (c) and (d),

in the case of scientific research and development, the persons concerned draw up and maintain written records detailing the identity 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 human or animal health or impact on the environment. This information shall, if requested, be made available to the competent authority,

in the case of process-oriented research and development, the information required in (a) is notified to the competent authority where and before placing on the market occurs and to the competent authority of the Member State where the experiment or test is to be conducted.

the name or business name of the applicant for, or the holder of, the authorisation or registration;

the trade name of the biocidal product;

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 classification;

the product-type and the use or uses for which it is authorised;

the type of formulation;

any proposed limits on residues which have been established;

conditions of the authorisation and where relevant, the reasons for the modification or cancellation of an authorisation;

an indication of whether the product is of a special type (e.g. within a frame-formulation, low-risk biocidal product).

the name and address of the applicant;

the name and address of the biocidal product manufacturer;

the name and address of the active substance manufacturer;

the names and content of the active substance or substances in the biocidal product and the name of the biocidal product;

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;

physical and chemical data concerning the active substance and biocidal product;

any ways of rendering the active substance or biocidal product harmless;

a summary of the results of the tests required pursuant to Article 8 to establish the substance's or product's efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance;

recommended methods and precautions to reduce dangers from handling, storage, transport and use as well as from fire or other hazards;

safety data sheets;

methods of analysis referred to in Article 5(1)(c);

methods of disposal of the product and of its packaging;

procedures to be followed and measures to be taken in the case of spillage or leakage;

first aid and medical advice to be given in the case of injury to persons.

products which may be mistaken for food, drink or feedingstuff shall be packaged to minimize the likelihood of such a mistake being made;

products available to the general public which may be mistaken for food, drink or feedingstuff shall contain components to discourage their consumption.

the identity of every active substance and its concentration in metric units;

the authorisation number allocated to the biocidal product by the competent authority;

the type of preparation (e.g. liquid concentrates, granules, powders, solids, etc.);

the uses for which the biocidal product is authorised (e.g. wood preservation, disinfection, surface biocide, anti-fouling, etc.);

directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorisation;

particulars of likely direct or indirect adverse side effects and any directions for first aid;

if accompanied by a leaflet, the - sentence ‘Read attached instructions before use’;

directions for safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on reuse of packaging;

the formulation batch number or designation and the expiry date relevant to normal conditions of storage;

the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by man or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use, storage and transport (e.g. personal protective clothing and equipment, measures for protection against fire, covering of furniture, removal of food and feedingstuff and directions to prevent animals from being exposed);

and where applicable:

the categories of users to which the biocidal product is restricted;

information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water;

for microbiological biocidal products, labelling requirements according to Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (46).

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.

an evaluation and recommendations concerning an active substance in accordance with Article 11(2) and/or an assessment according to Article 10(5), or

a proposal to refuse an authorisation or a registration and an explanatory document in accordance with Article 4(4),

it shall allow a period of 90 days during which other Member States and the applicant may submit comments to it in writing.

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,

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.

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.

Applicant

Identity of the active substance

Physical and chemical properties of the active substance

Methods of detection and identification

Effectiveness against target organisms and intended uses

Toxicological profile for man and animals including metabolism

Ecotoxicological profile including environmental fate and behaviour

Measures necessary to protect man, animals and the environment

Classification and labelling

Summary and evaluation of Sections II to IX

1.1.

Name and address, etc.

1.2.

Active substance manufacturer (name, address, location of plant)

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/1, as appropriate

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/1, 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 (1).

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 products

3.8.

Flammability including auto-flammability and identity of combustion products

3.9.

Flash-point

3.10.

Surface tension

3.11.

Explosive properties

3.12.

Oxidising properties

3.13.

Reactivity towards container material

4.1.

Analytical methods for the determination of pure active substance and, where appropriate, for relevant degradation products, isomers and impurities of the active substance and additives (e.g. stabilisers)

4.2.

Analytical methods including recovery rates and the limits of determination for the active substance, and for residues thereof, and where relevant in/on the following:

5.1.

Function, e.g. fungicide, rodenticide, insecticide, bactericide

5.2.

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 envisaged

5.6.

User: industrial, professional, general public (non-professional)

5.7.

Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies

5.8.

Likely tonnage to be placed on the market per year

6.1.

Acute toxicity

For studies 6.1.1 to 6.1.3, substances other than gases shall be administered via at least two routes, one of which should be the oral route. The choice of the second route will depend on 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.

Oral

6.1.2.

Dermal

6.1.3.

Inhalation

6.1.4.

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 available 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 studies

6.6.1.

In-vitro gene mutation study in bacteria

6.6.2.

In-vitro cytogenicity study in mammalian cells

6.6.3.

In-vitro gene mutation assay in mammalian cells

6.6.4.

If positive in 6.6.1, 6.6.2 or 6.6.3, then an in-vivo mutagenicity study will be required (bone marrow assay for chromosomal damage or a micronucleus test)

6.6.5.

If negative in 6.6.4 but positive in-vitro tests then undertake a second in-vivo study to examine whether mutagenicity or evidence of DNA damage can be demonstrated in tissue other than 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 species

6.8.2.

Fertility study — at least two generations, one species, male and female

6.9.

Medical data in anonymous form

6.9.1.

Medical surveillance data on manufacturing plant personnel if available

6.9.2.

Direct observation, e.g. clinical cases, poisoning incidents if available

6.9.3.

Health records, both from industry and any other available sources

6.9.4.

Epidemiological studies on the general population, if available

6.9.5.

Diagnosis of poisoning including specific signs of poisoning and clinical tests, if available

6.9.6.

Sensitisation/allergenicity observations, if available

6.9.7.

Specific treatment in case of an accident or poisoning: first aid measures, antidotes and medical treatment, if known

6.9.8.

Prognosis following poisoning

6.10.

Summary of mammalian toxicology and conclusions, including no observed adverse effect level (NOAEL), no observed effect level (NOEL), overall evaluation with regard to all toxicological data and any other information concerning the active substances. Where possible any suggested worker protection measures should be included in summary form

7.1.

Acute toxicity to fish

7.2.

Acute toxicity to Daphnia magna

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

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 beneficial and other non-target organisms

Hazard symbol(s)

Indications of danger

Risk phrases

Safety phrases

These data must be submitted for the purified active substance of stated specification.

These data must be submitted for the active substance of stated specification.

Eye irritation test shall not be necessary where the active substance has been shown to have potential corrosive properties.

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.

If, in exceptional circumstances, it is claimed that such testing is unnecessary, that claim must be fully justified.

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 development.

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.

Information may be derived from existing data where a justification acceptable to the competent authority is provided. In particular, the provisions of Directive 88/379/EEC should be used wherever possible to minimise animal testing.

Applicant

Identity of the biocidal product

Physical and chemical properties of the biocidal product

Methods for identification and analysis of the biocidal product

Intended uses of the biocidal product and efficacy for these uses

Toxicology data for the biocidal product (additional to that for the active substance)

Ecotoxicology data for the biocidal product (additional to that for the active substance)

Measures necessary to protect man, animals and the environment

Classification, packaging and labelling

Summary and evaluation of Sections II to IX

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))

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

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 ignition

3.5.

Acidity/alkalinity and if necessary pH value (1 % in water)

3.6.

Relative density

3.7.

Storage stability — stability and shelf-life. Effects of light, temperature and humidity on technical characteristics of the biocidal product; reactivity towards container material

3.8.

Technical characteristics of the biocidal product, e.g. wettability, persistent foaming, flowability, pourability and dustability

3.9.

Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised

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:

5.1.

Product type and field of use envisaged

5.2.

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, laboratory tests, or field trials, where appropriate

5.11.

Any other known limitations on efficacy including resistance

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.

Oral

6.1.2.

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 appropriate

6.2.

Skin and eye irritation(1)

6.3.

Skin sensitisation

6.4.

Information on dermal absorption

6.5.

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

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

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, antidotes, medical treatment if available; emergency measures to protect the environment; in so far as not covered by Annex IIA, paragraph 8.3

8.3.

Procedures, if any, for cleaning application equipment

8.4.

Identity of relevant combustion products in cases of fire

8.5.

Procedures for waste management of the biocidal product and its packaging for industry, professional users and the general public (non-professional users), e.g. possibility of reuse or recycling, neutralisation, conditions for controlled discharge, and incineration

8.6.

Possibility of destruction or decontamination following release in or on the following:

8.7.

Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms

8.8.

Specify any repellents or poison control measures included in the preparation that are present to prevent action against non-target organisms

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

Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.

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.

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.

1.

Solubility in organic solvents, including effect of temperature on solubility (1)

2.

Stability in organic solvents used in biocidal products and identity of relevant breakdown products (2)

1.

Analytical methods including recovery rates and the limits of determination for the active substance, and for residues thereof, in/on food or feedstuffs and other products where relevant

1.

Neurotoxicity study

If the active substance is an organophosphorus compound or if there are any other indications that the active substance may have neurotoxic properties then neurotoxicity studies will be required. The 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 humans

4.

Food and feedingstuffs

If the active substance is to be used in preparations for use where food for human consumption is prepared, consumed or stored, or where feedingstuff for livestock is prepared, consumed or stored 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

1.

Acute toxicity test on one other, non-aquatic, non-target organism

2.

If the results of the ecotoxicological studies and the intended use(s) of the active substance indicate a danger for the environment then the tests described in Sections XII and XIII shall be required

3.

If the result of the test in paragraph 7.6.1.2 of Annex IIA is negative and if the likely route of disposal of the active substance is by sewage treatment then the test described in Section XIII, part 4.1 shall be required

4.

Any other biodegradability tests that are relevant from the results in paragraphs 7.6.1.1 and 7.6.1.2 of Annex IIA

5.

Phototransformation in air (estimation method), including identification of breakdown products (1)

6.

If the results from paragraphs 7.6.1.2 in Annex IIA or from paragraph 4, above, indicate the need to do so, or the active substance has an overall low or absent abiotic degradation, then the tests described in Section XII, part 1.1, part 2.1 and, where appropriate, part 3 shall be required

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 (1)

These data must be submitted for the purified active substance of stated specification.

These data must be submitted for the active substance of stated specification.

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 1.8

2.

Other test(s) related to the exposure to humans

Suitable test(s) and a reasoned case will be required

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 metabolites and degradation products

1.4.

Extent and nature of bound residues

2.

Fate and behaviour in water

2.1.

Rate and route of degradation in aquatic systems (as far as is not covered by Annex IIA, paragraph 7.6) including identification of metabolites and degradation products

2.2.

Absorption and desorption in water (soil sediment systems) and, where relevant, absorption and desorption of metabolites and degradation products

3.

Fate and behaviour in air

If the active substance is to be used in preparations for fumigants, if it is to be applied by a spray method, if it is volatile, or if any other information indicates that this is relevant, then the rate 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

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 fish

2.2.

Effects on reproduction and growth rate on an appropriate species of fish

2.3.

Bioaccumulation in an appropriate species of fish

2.4.

Daphnia magna reproduction and growth rate

3.

Effects on other non-target organisms

3.1.

Acute toxicity to honeybees and other beneficial arthropods, e.g. predators. A different test organism shall be chosen from that used in Section VII, part 1

3.2.

Toxicity to earthworms and to other soil non-target macro-organisms

3.3.

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 4

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 development.

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.

Information may be derived from existing data where a justification acceptable to the competent authority is provided. In particular, the provisions of Directive 88/379/EEC should be used wherever possible to minimise animal testing.

1.

Food and feedingstuffs studies

1.1.

If residues of the biocidal product remain on feedingstuffs for a significant period of time, then feeding and metabolism studies in livestock shall be required to permit evaluation of residues in 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

1.

Where relevant all the information required in Annex IIIA, Section XII

2.

Testing for distribution and dissipation in the following:

Test requirements 1 and 2 above are applicable only to ecotoxicologically relevant components of the biocidal product

1.

Effects on birds

1.1.

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 organisms

2.1.2.

Residue data in fish concerning the active substance and including toxicologically relevant metabolites

2.1.3.

The studies referred to in Annex IIIA, Section XIII, parts 2.1, 2.2, 2.3 and 2.4 may be required for relevant components of the biocidal product

2.2.

If the biocidal product is to be sprayed near to surface waters then an overspray study may be required to assess risks to aquatic organisms under field conditions

3.

Effects on other non-target organisms

3.1.

Toxicity to terrestrial vertebrates other than birds

3.2.

Acute toxicity to honeybees

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 3

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.

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.

Applicant details

Identity of the active organism

Source of active organism

Methods of detection and identification

Biological properties of active organism including pathogenicity and infectivity for target and non-target organisms including man

Effectiveness and intended uses

Toxicological profile for man and animals including metabolism of toxins

Ecotoxicological profile including environmental fate and behaviour of the organisms and of toxins it produces

Measures necessary to protect man, non-target organisms and the environment

Classification and labelling

Summary and evaluation of Sections II to X

1.1.

Applicant (name, address, etc.)

1.2.

Manufacturer (name, address, plant location)

2.1.

Common name of organism (including alternative and superseded names)

2.2.

Taxonomic name and strain indicating whether it is a stock variant or a mutant strain; for viruses, taxonomic designation of the agent, serotype, strain or mutant

2.3.

Collection and culture reference number where the culture is deposited

2.4.

Methods, procedures and criteria used to establish the presence and identity of the organism (e.g. morphology, biochemistry, serology, etc.)

3.1.

Occurrence in nature or otherwise

3.2.

Isolation methods for organism or active strain

3.3.

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 strains

3.5.

Composition of the final active organism material i.e. nature, purity, identity, properties, content of any impurities and extraneous organisms

3.6.

Methods to prevent contamination of seed stock and loss of virulence of seed stock

3.7.

Procedures for waste management

4.1.

Methods for establishing the presence and identity of the organism

4.2.

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 relevant temperatures)

4.5.

Methods to determine viable and non-viable (e.g. toxins) residues in or on treated products, foodstuffs, feedingstuffs, animal and human body fluids and tissues, soil, water and air, where relevant

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 information 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 organisms

5.7.

Any other biological effects on non-target organisms when properly used

5.8.

Infectivity and physical stability when properly used

5.9.

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

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 effects

6.4.

Information on the occurrence or possible occurrence of the development of resistance and possible management strategies to deal with this

6.5.

Effects on target organisms

6.6.

Category of user

7.1.

Acute toxicity

In cases where a single dose is not appropriate, a set of range finding tests must be carried out to reveal highly toxic agents and infectivity

7.2.

Sub-chronic toxicity

40-day study, two species, one rodent, one non-rodent

7.3.

Chronic toxicity

Two species, rodent and one other mammal, oral administration unless another route is more appropriate

7.4.

Carcinogenicity study

May be combined with studies in 6.3. One rodent and one other mammal

7.5.

Mutagenicity studies

As specified in Annex IIA, Section VI, part 6.6

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) distribution and excretion in mammals including elucidation of metabolic pathways

7.8.

Neurotoxicity studies: required where there is any indication of anticholinerterase activity or other neurotoxic effects. Delayed neurotoxicity tests using adult hens should be performed 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:

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 form

8.1.

Acute toxicity to fish

8.2.

Acute toxicity to Daphnia magna

8.3.

Effects on algae growth (inhibition test)

8.4.

Acute toxicity on one other, non-aquatic, non-target organism

8.5.

Pathogenicity and infectivity for honeybees and earthworms

8.6.

Acute toxicity and/or pathogenicity and infectivity for other non-target organisms believed to be at risk

8.7.

Effects (if any) on other flora and fauna

8.8.

In cases where toxins are produced, data as outlined in Annex IIA, Section VII, parts 7.1 to 7.5 should be produced

Fate and behaviour in the environment

8.9.

Spread, mobility, multiplication and persistence in air, soil and water

8.10.

In cases where toxins are produced, data as outlined in Annex IIA, Section VII, parts 7.6 to 7.8

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

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 development.

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.

Information may be derived from existing data where a justification acceptable to the competent authority is provided. In particular, the provisions of Directive 88/379/EEC should be used wherever possible to minimise animal testing.

Applicant

Identity and composition of the biocidal product

Technical properties of the biocidal product and any biocidal properties additional to those of the active organism

Methods for identification and analysis of the biocidal product

Intended uses and efficacy for those uses

Toxicological information (additional to that for the active organism)

Ecotoxicological information (additional to that for the active organism)

Measures to be adopted to protect humans, non-target organisms and the environment

Classification, packaging and labelling of the biocidal product

Summary of Sections II to IX

1.1.

Name and address, etc.

1.2.

Manufacturers of biocidal products and active organisms including location of plants

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 concentrate, wettable powder, etc.)

2.4.

Concentration of active organism in material used

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 product

3.4.1.

Wettability

3.4.2.

Persistent foaming

3.4.3.

Suspensibility and suspension stability

3.4.4.

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 1 mm

3.4.7.

Content of active substance in or on bait particles, granules or treated material

3.4.8.

Emulsifiability, re-emulsifiability, emulsion stability

3.4.9.

Flowability, pourability and dustability

3.5.

Physical and chemical compatibility with other products including biocidal products with which its use is to be authorised

3.6.

Wetting, adherence and distribution following application

3.7.

Any changes to biological properties of the organism is a result of formulation. In particular changes in pathogenicity on infectivity

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 product

4.4.

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

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 rate

5.4.

Where necessary, in the light of the test results, any specific circumstances or environmental conditions under which the product may or may not be used

5.5.

Method of application

5.6.

Number and timing of applications

5.7.

Proposed instructions for use

Efficacy data

5.8.

Preliminary range-finding tests

5.9.

Field experimentation

5.10.

Information on the possible occurrence of the development of resistance

5.11.

Effects on the quality of materials or products treated

6.1.

Oral single dose

6.2.

Percutaneous single dose

6.3.

Inhalation

6.4.

Skin and where relevant eye irritation

6.5.

Skin sensitisation

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 relevant quantitative analysis of operator exposure

7.1.

Observations concerning undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms or persistence in 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 accident

8.4.

Procedures for destruction or decontamination of the biocidal product and its packaging

9.1.

Proposals including justification for the classification, packaging and labelling

9.2.

Packaging (type, materials, size, etc.), compatibility of the biocidal product with proposed packaging materials

9.3.

Specimens of proposed packaging

General principles

Effects on humans

Effects on animals

Effects on the environment

Unacceptable effects

Efficacy

Summary

General principles

Effects on humans

Effects on animals

Effects on the environment

Unacceptable effects

Efficacy

Summary

Hazard identification

This is the identification of the adverse effects which a biocidal product has an inherent capacity to cause.

Dose (concentration) — response (effect) assessment

This is the estimate of the relationship between the dose, or level of exposure, of an active substance or substance of concern in a biocidal product and the incidence and severity of an effect.

Exposure assessment

This is the determination of the emissions, pathways and rates of movement of an active substance or a substance of concern in a biocidal product and its transformation or degradation in order to estimate the concentration/doses to which human populations, animals or environmental compartments are or may be exposed.

Risk characterisation

This is the estimation of the incidence and severity of the adverse effects likely to occur in a human population, animals or environmental compartments due to actual or predicted exposure to any active substance or substance of concern in a biocidal product. This may include ‘risk estimation’ i.e. the quantification of that likelihood.

Environment

Water, including sediment, air, land, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms.

1.

This Annex lays down principles to ensure that evaluations made and decisions taken by a Member State concerning the authorisation of a biocidal product providing it is a chemical preparation 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 identified during the proposed normal use of the biocidal product. This is done by carrying out an assessment of the risks associated with the relevant individual components of the biocidal product.

3.

A risk assessment on the active substance or substances present in the biocidal product is always required. This will already have been carried out for the purpose of Annexes I, IA or IB. This 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 associated risks. The data required shall be the minimum necessary to carry out an appropriate risk assessment. Member States should take due consideration 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:

8.

The Member State shall comply with the requirements of mutual recognition as stated in Articles 4(1), (2) and (6) of this Directive.

9.

It is known that many biocidal products present only minor differences in composition and this should be taken into account when evaluating dossiers. The concept of ‘frame-formulations’ is relevant here.

10.

It is known that certain biocidal products are considered as posing only a low risk, these biocidal products, while complying with the requirements of this Annex, are subject to a simplified 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 authorisation 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 enterprises (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 decision-making process must be based on scientific principles, preferably recognised at international level, and be made with the benefit of expert advice.

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:

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.

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:

22.

The populations previously mentioned are:

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 characterisation in relation to that effect shall not be necessary unless there are other reasonable grounds for concern, e.g. adverse environmental effects or unacceptable residues.

25.

The Member State shall apply paragraphs 26 to 29 when carrying out a dose (concentration) — response (effect) assessment on an active substance or a substance of concern present in a biocidal product.

26.

For repeated dose toxicity and reproductive toxicity the dose response relationship shall be assessed for each active substance or substance of concern and, where possible, the no-observed-adverse-effect level (NOAEL) identified. If it is not possible to identify a NOAEL, the lowest-observed-adverse-effect level (LOAEL) shall be identified.

27.

For acute toxicity, corrosivity and irritation, it is not usually possible to derive a NOAEL or LOAEL on the basis of tests conducted in accordance with the requirements of this Directive. For 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 capacity to cause such effects during use of the biocidal product. However, if it can be demonstrated that an active substance or a substance of concern identified as 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 sensitised 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 populations (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 make a quantitative or qualitative estimate of the dose/concentration of each active substance or substance of concern to which a population is, or may be exposed during use of the biocidal product.

32.

The exposure assessment shall be based on the information in the technical dossier provided in conformity with Article 8 of this Directive and on any other available and relevant information. Particular account shall be taken, as appropriate, of:

33.

Where adequately measured, representative exposure data are available, special consideration shall be given to them when conducting the exposure assessment. Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied.

These models shall:

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.

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.

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 characterisation shall be required.

38.

In those cases where the test appropriate to hazard identification in relation to a particular potential effect of an active substance or a substance of concern present in a biocidal product has been conducted but the results have not led to classification of the biocidal product then risk characterisation in relation to that effect shall not be necessary unless there are other reasonable grounds for concern. Such grounds may derive from the properties and effects of any active substance or substance of concern in the biocidal product, in particular: