(a) the establishment at Union level of a list of active substances which may be used in biocidal products; (b) the authorisation of biocidal products; (c) the mutual recognition of authorisations within the Union; (d) the making available on the market and the use of biocidal products within one or more Member States or the Union; (e) the placing on the market of treated articles.
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance
Modified by
- Commission Delegated Regulation (EU) No 736/2013of 17 May 2013amending Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the duration of the work programme for examination of existing biocidal active substances(Text with EEA relevance), 32013R0736, July 31, 2013
- Commission Delegated Regulation (EU) No 837/2013of 25 June 2013amending Annex III to Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the information requirements for authorisation of biocidal products(Text with EEA relevance), 32013R0837, September 3, 2013
- Regulation (EU) No 334/2014 of the European Parliament and of the Councilof 11 March 2014amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market(Text with EEA relevance), 32014R0334, April 5, 2014
Corrected by
- Corrigendum to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, 32012R0528R(08), October 28, 2017
(a) 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 CommunityOJ L 92, 7.4.1990, p. 42 .(b) Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC; (c) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal productsOJ L 311, 28.11.2001, p. 1 .6 November 2001 on the Community code relating to medicinal products for human useOJ L 311, 28.11.2001, p. 67 .31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines AgencyOJ L 136, 30.4.2004, p. 1 .(d) Regulation (EC) No 1831/2003; (e) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffsOJ L 139, 30.4.2004, p. 1 .29 April 2004 laying down specific hygiene rules for food of animal originOJ L 139, 30.4.2004, p. 55 .(f) Regulation (EC) No 1333/2008; (g) Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foodsOJ L 354, 31.12.2008, p. 34 .(h) Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feedOJ L 229, 1.9.2009, p. 1 .(i) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the marketOJ L 309, 24.11.2009, p. 1 .(j) Regulation (EC) No 1223/2009; (k) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toysOJ L 170, 30.6.2009, p. 1 .
(a) 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 substancesOJ 196, 16.8.1967, p. 1 .(b) 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 workOJ L 183, 29.6.1989, p. 1 .(c) Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at workOJ L 131, 5.5.1998, p. 11 .(d) Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumptionOJ L 330, 5.12.1998, p. 32 .(e) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparationsOJ L 200, 30.7.1999, p. 1 .(f) Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at workOJ L 262, 17.10.2000, p. 21 .(g) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policyOJ L 327, 22.12.2000, p. 1 .(h) Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at workOJ L 158, 30.4.2004, p. 50 .(i) Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutantsOJ L 158, 30.4.2004, p. 7 .(j) Regulation (EC) No 1907/2006; (k) Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertisingOJ L 376, 27.12.2006, p. 21 .(l) Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicalsOJ L 204, 31.7.2008, p. 1 .(m) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixturesOJ L 353, 31.12.2008, p. 1 .(n) Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticidesOJ L 309, 24.11.2009, p. 71 .(o) Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layerOJ L 286, 31.10.2009, p. 1 .(p) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposesOJ L 276, 20.10.2010, p. 33 .(q) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissionsOJ L 334, 17.12.2010, p. 17 .
(a) food or feed used as repellents or attractants; (b) biocidal products when used as processing aids within the meaning of Regulation (EC) No 1831/2003 and Regulation (EC) No 1333/2008.
(a) "biocidal product" means any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action, any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
A treated article that has a primary biocidal function shall be considered a biocidal product. (b) "micro-organism" means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths; (c) "active substance" means a substance or a micro-organism that has an action on or against harmful organisms; (d) "existing active substance" means a substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;(e) "new active substance" means a substance which was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;(f) "substance of concern" means any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect. Such a substance would, unless there are other grounds for concern, normally be: a substance classified as dangerous or that meets the criteria to be classified as dangerous according to Directive 67/548/EEC, and that is present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC, or a substance classified as hazardous or that meets the criteria for classification as hazardous according to Regulation (EC) No 1272/2008, and that is present in the biocidal product at a concentration leading the product to be regarded as hazardous within the meaning of that Regulation, a substance which meets the criteria for being a persistent organic pollutant (POP) under Regulation (EC) No 850/2004, or which meets the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII to Regulation (EC) No 1907/2006;
(g) "harmful organism" means an organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment; (h) "residue" means a substance present in or on products of plant or animal origin, water resources, drinking water, food, feed or elsewhere in the environment and resulting from the use of a biocidal product, including such a substance’s metabolites, breakdown or reaction products; (i) "making available on the market" means any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge; (j) "placing on the market" means the first making available on the market of a biocidal product or of a treated article; (k) "use" means all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union; (l) "treated article" means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products; (m) "national authorisation" means an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof; (n) "Union authorisation" means an administrative act by which the Commission authorises the making available on the market and the use of a biocidal product or a biocidal product family in the territory of the Union or in a part thereof; (o) "authorisation" means national authorisation, Union authorisation or authorisation in accordance with Article 26; (p) "authorisation holder" means the person established within the Union who is responsible for the placing on the market of a biocidal product in a particular Member State or in the Union and specified in the authorisation; (q) "product-type" means one of the product-types specified in Annex V; (r) "single biocidal product" means a biocidal product with no intended variations as to the percentage of the active or non-active substances it contains; (s) "biocidal product family" means a group of biocidal products having: (i) similar uses; (ii) the same active substances; (iii) similar composition with specified variations; and (iv) similar levels of risk and efficacy;
(t) "letter of access" means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by competent authorities, the Agency, or the Commission for the purposes of this Regulation; (u) "food" and "feed" mean food as defined in Article 2 of Regulation (EC) No 178/2002 and feed as defined in Article 3(4) of that Regulation; (v) "processing aid" means any substance falling within the definition of point (b) of Article 3(2) of Regulation (EC) No 1333/2008 or point (h) of Article 2(2) of Regulation (EC) No 1831/2003; (w) "technical equivalence" means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54; (x) "Agency" means the European Chemicals Agency established by Regulation (EC) No 1907/2006; (y) "advertisement" means a means of promoting the sale or use of biocidal products by printed, electronic or other media; (z) "nanomaterial" means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. For the purposes of the definition of nanomaterial, "particle", "agglomerate" and "aggregate" are defined as follows: "particle" means a minute piece of matter with defined physical boundaries, "agglomerate" means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components, "aggregate" means a particle comprising strongly bound or fused particles;
(aa) "administrative change" means an amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family; (ab) "minor change" means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family; (ac) "major change" means an amendment of an existing authorisation which is neither an administrative change nor a minor change; (ad) "vulnerable groups" means persons needing specific consideration when assessing the acute and chronic health effects of biocidal products. These include pregnant and nursing women, the unborn, infants and children, the elderly and, when subject to high exposure to biocidal products over the long term, workers and residents; (ae) "small and medium-sized enterprises" or "SMEs" means small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprisesOJ L 124, 20.5.2003, p. 36 .
(a) "substance"; (b) "mixture"; (c) "article"; (d) "product and process-orientated research and development"; (e) "scientific research and development".
(a) the minimum degree of purity of the active substance; (b) the nature and maximum content of certain impurities; (c) the product-type; (d) manner and area of use including, where relevant, use in treated articles; (e) designation of categories of users; (f) where relevant, characterisation of the chemical identity with regard to stereoisomers; (g) other particular conditions based on the evaluation of the information related to that active substance; (h) the date of approval and the expiry date of the approval of the active substance.
(a) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, carcinogen category 1A or 1B; (b) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen category 1A or 1B; (c) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B; (d) active substances which, on the basis of the criteria specified pursuant to the first subparagraph of paragraph 3 or, pending the adoption of those criteria, on the basis of the second and third subparagraphs of paragraph 3, are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties; (e) active substances which meet the criteria for being PBT or vPvB according to Annex XIII to Regulation (EC) No 1907/2006.
(a) the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim at excluding contact with humans and release into the environment; (b) it is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or (c) not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.
(a) a dossier for the active substance satisfying the requirements set out in Annex II; (b) a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and (c) if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.
(a) the data are not necessary owing to the exposure associated with the proposed uses; (b) it is not scientifically necessary to supply the data; or (c) it is not technically possible to generate the data.
(a) adopt an implementing Regulation providing that an active substance is approved, and under which conditions, including the dates of approval and of expiry of the approval; or (b) in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, adopt an implementing decision that an active substance is not approved.
(a) it meets at least one of the exclusion criteria listed in Article 5(1) but may be approved in accordance with Article 5(2); (b) it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser; (c) its acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario; (d) it meets two of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006; (e) there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures; (f) it contains a significant proportion of non-active isomers or impurities.
(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial approval or, as appropriate, previous renewal; and (b) its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.
(a) an implementing regulation providing that the approval of an active substance is renewed for one or more product-types, and under which conditions; or (b) an implementing decision that the approval of an active substance is not renewed.
(a) the promotion of best practices as a means of reducing the use of biocidal products to a minimum; (b) the most effective approaches for monitoring the use of biocidal products; (c) the development and application of integrated pest management principles with respect to the use of biocidal products; (d) the risks posed by the use of biocidal products in specific areas such as schools, workplaces, kindergartens, public spaces, geriatric care centres or in the vicinity of surface water or groundwater and whether additional measures are needed to address those risks; (e) the role that improved performance of the equipment used for applying biocidal products could play in sustainable use.
(a) the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met; (b) it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria: (i) the biocidal product is sufficiently effective; (ii) the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates; (iii) the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects; (iv) the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations: the fate and distribution of the biocidal product in the environment, contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation, the impact of the biocidal product on non-target organisms, the impact of the biocidal product on biodiversity and the ecosystem;
(c) the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III; (d) the physical and chemical properties of the biocidal product have been determined and deemed acceptable for the purposes of the appropriate use and transport of the product; (e) where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with Council Regulation (EEC) No 315/93 Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1 ).Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1 ).Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11 ).Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10 ).Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4 ).(f) where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.
(a) realistic worst case conditions under which the biocidal product may be used; (b) the way in which treated articles treated with the biocidal product or containing the biocidal product may be used; (c) the consequences of use and disposal of the biocidal product; (d) cumulative effects; (e) synergistic effects.
(a) it meets the criteria according to Directive 1999/45/EC for classification as: toxic or very toxic, a category 1 or 2 carcinogen, a category 1 or 2 mutagen, or toxic for reproduction category 1 or 2;
(b) it meets the criteria according to Regulation (EC) No 1272/2008 for classification as: acute oral toxicity category 1, 2 or 3, acute dermal toxicity category 1, 2 or 3, acute inhalation toxicity (gases and dust/mist) category 1, 2 or 3, acute inhalation toxicity (vapours) category 1 or 2, specific target organ toxicity by single or repeated exposure category 1, a category 1A or 1B carcinogen, a category 1A or 1B mutagen, or toxic for reproduction category 1A or 1B;
(c) it consists of, contains or generates, a substance that meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006; (d) it has endocrine-disrupting properties; or (e) it has developmental neurotoxic or immunotoxic effects.
(a) the application explicitly identifies the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the assessment is based, as well as the permitted variations in composition and uses referred to in point (s) of Article 3(1) together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and (b) it can be established based on the assessment referred to in the first subparagraph of this paragraph that all the biocidal products within the family comply with the conditions set out in paragraph 1.
(a) for biocidal products other than biocidal products meeting the conditions laid down in Article 25: (i) a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III; (ii) a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2), as applicable; (iii) a dossier or a letter of access for the biocidal product satisfying the requirements set out in Annex II for each active substance in the biocidal product;
(b) for biocidal products that the applicant considers meet the conditions laid down in Article 25: (i) a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph; (ii) efficacy data; and (iii) any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.
(a) the data are not necessary owing to the exposure associated with the proposed uses; (b) it is not scientifically necessary to supply the data; or (c) it is not technically possible to generate the data.
(a) trade name of the biocidal product; (b) name and address of the authorisation holder; (c) date of the authorisation and its date of expiry; (d) authorisation number of the biocidal product, together with, in the case of a biocidal product family, the suffixes to apply to individual biocidal products within the biocidal product family; (e) qualitative and quantitative composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %; (f) manufacturers of the biocidal product (names and addresses including location of manufacturing sites); (g) manufacturers of the active substances (names and addresses including location of manufacturing sites); (h) type of formulation of the biocidal product; (i) hazard and precautionary statements; (j) product-type and, where relevant, an exact description of the authorised use; (k) target harmful organisms; (l) application doses and instructions for use; (m) categories of users; (n) particulars of likely direct or indirect adverse effects and first aid instructions and emergency measures to protect the environment; (o) instructions for safe disposal of the product and its packaging; (p) conditions of storage and shelf-life of the biocidal product under normal conditions of storage; (q) where relevant, other information about the biocidal product.
(a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human health, animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages; (b) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.
(a) all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex; (b) the biocidal product does not contain any substance of concern; (c) the biocidal product does not contain any nanomaterials; (d) the biocidal product is sufficiently effective; and (e) the handling of the biocidal product and its intended use do not require personal protective equipment.
(a) they meet the criteria for classification according to Regulation (EC) No 1272/2008 as: explosive/highly flammable, organic peroxide, acutely toxic of category 1, 2 or 3, corrosive of category 1A, 1B or 1C, respiratory sensitiser, skin sensitiser, germ cell mutagen of category 1 or 2; carcinogen of category 1 or 2, human reproductive toxicant of category 1 or 2 or with effects on or via lactation, specific target organ toxicant by single or repeated exposure, or toxic to aquatic life of acute category 1;
(b) they fulfil any of the substitution criteria set out in Article 10(1); or (c) they have neurotoxic or immunotoxic properties.
(a) the relevant information referred to in Article 20 has been submitted; and (b) the applicant states that it has not applied to any other competent authority for a national authorisation for the same biocidal product for the same use(s).
(a) draft a report summarising the conclusions of its assessment and the reasons for authorising the biocidal product or for refusing to grant an authorisation (the "assessment report"); (b) send an electronic copy of the draft assessment report to the applicant and provide it with the opportunity to submit comments within 30 days; and (c) take due account of those comments when finalising its assessment.
(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation or, as appropriate, previous renewal; and (b) its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.
(a) the information referred to in Article 20; (b) a list of all other Member States where a national authorisation is sought ("the Member States concerned").
(a) the names of the reference Member State and of the Member States concerned; (b) the summary of biocidal product characteristics referred to in Article 20(1)(a)(ii) in such official languages of the Member States concerned as they may require.
(a) the protection of the environment; (b) public policy or public security; (c) the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants; (d) the protection of national treasures possessing artistic, historic or archaeological value; or (e) the target organisms not being present in harmful quantities.
(a) may ask the Agency for an opinion on scientific or technical questions raised by the applicant or the Member State concerned; (b) shall adopt a decision on the derogation in accordance with the examination procedure referred to in Article 82(3).
(a) from 1 September 2013 , to biocidal products containing one or more new active substances and biocidal products of product-types 1, 3, 4, 5, 18 and 19;(b) from 1 January 2017 , to biocidal products of product-types 2, 6 and 13; and(c) from 1 January 2020 , to biocidal products of all remaining product-types.
(a) a statement on whether the conditions laid down in Article 19(1) are fulfilled, and a draft summary of biocidal product characteristics, as referred to in Article 22(2); (b) where relevant, details of any terms or conditions which should be imposed on the making available on the market or use of the biocidal product; (c) the final assessment report on the biocidal product.
(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation or, as appropriate, previous renewal; and (b) its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.
(a) new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, animals or the environment; (b) any data indicating the potential of the active substance for the development of resistance; (c) new data or information indicating that the biocidal product is not sufficiently effective.
(a) the conditions referred to in Article 19 or, where relevant, in Article 25 are not satisfied; (b) the authorisation was granted on the basis of false or misleading information; or (c) the authorisation holder has failed to comply with its obligations under the authorisation or this Regulation.
(a) administrative change; (b) minor change; or (c) major change.
(a) a simplified notification procedure shall be applied for administrative changes; (b) a reduced evaluation period shall be established for minor changes; (c) in the case of major changes, the evaluation period shall be proportionate to the extent of the proposed change.
(a) they have been manufactured by the same company, by an associated undertaking or under license in accordance with the same manufacturing process; (b) they are identical in specification and content in respect of the active substances and the type of formulation; (c) they are the same in respect of the non-active substances present; and (d) they are either the same or equivalent in packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human health, animal health or the environment.
(a) name and authorisation number of the biocidal product in the Member State of origin; (b) name and address of the competent authority of the Member State of origin; (c) name and address of the authorisation holder in the Member State of origin; (d) original label and instructions for use with which the biocidal product is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction; (e) name and address of the applicant; (f) name to be given to the biocidal product to be distributed in the Member State of introduction; (g) a draft label for the biocidal product intended to be made available on the market in the Member State of introduction in the official language or languages of the Member State of introduction, unless that Member State provides otherwise; (h) a sample of the biocidal product which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction; (i) name and authorisation number of the reference product in the Member State of introduction.
in the case of a treated article containing a biocidal product, a claim is made by the manufacturer of that treated article regarding the biocidal properties of the article, or in relation to the active substance(s) concerned, having particular regard to the possibility of contact with humans or the release into the environment, the conditions associated with the approval of the active substance(s) so require.
(a) a statement that the treated article incorporates biocidal products; (b) where substantiated, the biocidal property attributed to the treated article; (c) without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products; (d) the name of all nanomaterials contained in the biocidal products, followed by the word "nano" in brackets; (e) any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates.
(a) the subsequent applicant submits a letter of access; or (b) the relevant time limit for data protection has expired.
(a) the name and contact details of the data owner and the beneficiary; (b) the name of the active substance or biocidal product for which access to the data is authorised; (c) the date on which the letter of access takes effect; (d) a list of the submitted data to which the letter of access grants citation rights.
(a) shall, in the case of data involving tests on vertebrates; and (b) may, in the case of data not involving tests on vertebrates,
(a) shall, in the case of data involving tests on vertebrates; and (b) may, in the case of data not involving tests on vertebrates,
(a) all necessary data for the identification of the biocidal product, including its composition; (b) the data needed to identify the active substance and to establish technical equivalence of the active substance; (c) the data needed to demonstrate the comparability of the risk from and efficacy of the biocidal product to that of the authorised biocidal product.
(a) safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product; (b) records of the various manufacturing operations performed; (c) results of internal quality controls; (d) identification of production batches.
(a) information on the results of official controls carried out in accordance with paragraph 2; (b) information on any poisonings and, where available, occupational diseases involving biocidal products, especially regarding vulnerable groups, and any specific measures taken to mitigate the risk of future cases; (c) any available information on adverse environmental effects experienced through using biocidal products; (d) information on the use of nanomaterials in biocidal products and the potential risks thereof.
(a) details of the full composition of a biocidal product; (b) the precise tonnage of the active substance or biocidal product manufactured or made available on the market; (c) links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product; (d) names and addresses of persons involved in testing on vertebrates.
(a) the name and address of the authorisation holder; (b) the name and address of the biocidal product manufacturer; (c) the name and address of the active substance manufacturer; (d) the content of the active substance or substances in the biocidal product and the name of the biocidal product; (e) physical and chemical data concerning the biocidal product; (f) any methods for rendering the active substance or biocidal product harmless; (g) a summary of the results of the tests required pursuant to Article 20 to establish the product’s efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance; (h) recommended methods and precautions to reduce dangers from handling, transport and use as well as from fire or other hazards; (i) safety data sheets; (j) methods of analysis referred to in Article 19(1)(c); (k) methods of disposal of the product and of its packaging; (l) procedures to be followed and measures to be taken in the case of spillage or leakage; (m) first aid and medical advice to be given in the case of injury to persons.
(a) where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature; (b) if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances; (c) the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1); (d) physicochemical endpoints and data on pathways and environmental fate and behaviour; (e) the result of each toxicological and ecotoxicological study; (f) acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI; (g) the guidance on safe use provided in accordance with Annexes II and III; (h) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II.
(a) the terms and conditions of the authorisation; (b) the summary of the biocidal product characteristics; and (c) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III.
(a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous; (b) the study summaries or robust study summaries of studies submitted to support the approval of the active substance; (c) information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet; (d) the trade name(s) of the substance; (e) the assessment report.
(a) study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and (b) the assessment report.
(a) the identity of every active substance and its concentration in metric units; (b) the nanomaterials contained in the product, if any, and any specific related risks, and, following each reference to nanomaterials, the word "nano" in brackets; (c) the authorisation number allocated to the biocidal product by the competent authority or the Commission; (d) the name and address of the authorisation holder; (e) the type of formulation; (f) the uses for which the biocidal product is authorised; (g) directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation; (h) particulars of likely direct or indirect adverse side effects and any directions for first aid; (i) if accompanied by a leaflet, the sentence "Read attached instructions before use" and, where applicable, warnings for vulnerable groups; (j) directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging; (k) the formulation batch number or designation and the expiry date relevant to normal conditions of storage; (l) where applicable, 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 humans 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 and transport; (m) where applicable, the categories of users to which the biocidal product is restricted; (n) where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water; (o) for biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.
(a) the provision of models or drafts of the packaging, labelling and leaflets; (b) that biocidal products made available on the market in their territories be labelled in their official language or languages.
(a) the terms and conditions of the authorisation; (b) the summary of the biocidal product characteristics referred to in Article 22(2); (c) the assessment report of the biocidal product.
(a) applications for approval and renewal of approval of active substances; (b) review of approval of active substances; (c) applications for inclusion in Annex I of active substances meeting the conditions laid down in Article 28 and review of the inclusion of such active substances in Annex I; (d) identification of active substances which are candidates for substitution; (e) applications for Union authorisation of biocidal products and for renewal, cancellation and amendments of Union authorisations, except where the applications are for administrative changes; (f) scientific and technical matters concerning mutual recognition in accordance with Article 38; (g) at the request of the Commission or of Member States’ competent authorities, any other questions that arise from the operation of this Regulation relating to technical guidance or risks to human health, animal health or the environment.
(a) establishing and maintaining the Register for Biocidal Products; (b) performing the tasks relating to the acceptance of the applications covered by this Regulation; (c) establishing technical equivalence; (d) providing technical and scientific guidance and tools for the application of this Regulation by the Commission and Member States’ competent authorities and providing support to national helpdesks; (e) providing advice and assistance to applicants, in particular to SMEs, for the approval of an active substance or its inclusion in Annex I to this Regulation or for a Union authorisation; (f) preparing explanatory information on this Regulation; (g) establishing and maintaining database(s) with information on active substances and biocidal products; (h) at the request of the Commission, providing technical and scientific support to improve cooperation between the Union competent authorities, international organisations and third countries on scientific and technical issues relating to biocidal products; (i) notification of decisions taken by the Agency; (j) specification of formats and software packages for the submission of information to the Agency; (k) providing support and assistance to Member States in order to avoid the parallel assessment of applications relating to the same or similar biocidal products referred to in Article 29(4); (l) providing support and assistance to Member States with regard to control and enforcement activities.
(a) a subsidy from the Union, entered in the general budget of the European Union (Commission Section); (b) the fees paid to the Agency in accordance with this Regulation; (c) any charges paid to the Agency for services that it provides under this Regulation; (d) any voluntary contributions from Member States.
(a) the fees payable to the Agency, including an annual fee for products granted a Union authorisation in accordance with Chapter VIII and a fee for applications for mutual recognition in accordance with Chapter VII; (b) the rules defining conditions for reduced fees, fee waivers and the reimbursement of the member of the Biocidal Products Committee who acts as a rapporteur; and (c) conditions of payment.
(a) fees shall be set at such a level as to ensure that the revenue derived from the fees is, in principle, sufficient to cover the cost of the services delivered and shall not exceed what is necessary to cover those costs; (b) partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time limit; (c) the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases; (d) the structure and amount of fees shall take into account whether information has been submitted jointly or separately; (e) in duly justified circumstances, and where it is accepted by the Agency or the competent authority, the whole fee or a part of it may be waived; and (f) the deadlines for the payment of fees shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.
(a) existing active substances which: (i) have been evaluated under Commission Regulation (EC) No 1451/2007 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3 ).(ii) are being evaluated, under Regulation (EC) No 1451/2007, but which have not yet been approved for that product-type;
or (b) a combination of active substances referred to in point (a) and active substances approved in accordance with this Regulation. By way of derogation from the first subparagraph, in the case of a decision not to approve an active substance, a Member State may continue to apply its current system or practice of making biocidal products available on the market for up to 12 months after the date of the decision not to approve an active substance in accordance with the third subparagraph of paragraph 1, and may continue to apply its current system or practice of using biocidal products for up to 18 months after that decision.
(a) the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and (b) use of existing stocks of the biocidal product may continue for up to 365 days after the date of approval of the active substance(s).
(a) a biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 180 days after the date of the decision of the authority; and (b) use of existing stocks of the biocidal product may continue for up to 365 days after the date of the decision of the authority.
where the risk assessment of the active substance indicates that one or more of the criteria listed under Article 5(1) is met, the biocidal product shall be authorised in accordance with Article 19, where the risk assessment of the active substance indicates that one or more of the criteria listed under Article 10 is met, the biocidal product shall be authorised in accordance with Article 23.
(a) where applications for approval of all those active substances, which the biocidal product consists of, contains or generates, are submitted for the relevant product-type by 1 September 2016 , the deadlines provided for in the second subparagraph of Article 89(2), in Article 89(3) and in Article 89(4); or(b) where an application is not submitted in accordance with point (a) for one of the active substances, until 1 September 2017 .
(a) in the case of a decision adopted after 1 September 2016 to reject the application for approval of, or not to approve, one of the active substances for the relevant use, the date falling 180 days after such a decision;(b) in other cases, the date of approval for the relevant product-type and use of the last active substance to be approved and contained in the biocidal product.
| EC number | Name/group | Restriction | Comment |
|---|---|---|---|
| 200-018-0 | Lactic acid | Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 | E 270 |
| 204-823-8 | Sodium acetate | Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 | E 262 |
| 208-534-8 | Sodium benzoate | Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 | E 211 |
| 201-766-0 | (+)-Tartaric acid | Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 | E 334 |
| 200-580-7 | Acetic acid | Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 | E 260 |
| 201-176-3 | Propionic acid | Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 | E 280 |
| 200-066-2 | Ascorbic acid | ||
| 232-278-6 | Linseed oil | ||
| Natural oil | Lavender oil | CAS 8000-28-0 | |
| Natural oil | Peppermint oil | CAS 8006-90-4 | |
| 222-226-0 | Oct-1-en-3-ol | ||
| Mixture | Webbing clothes moths pheromone | ||
| 204-696-9 | Carbon dioxide | Only for use in ready-for-use gas canisters functioning together with a trapping device | |
| 231-783-9 | Nitrogen | Only for use in limited quantities in ready-for-use canisters | |
| Not available | (9Z,12E)-tetradeca-9,12-dien-1-yl acetate | CAS 30507-70-1 | |
| Baculovirus | |||
| 215-108-5 | Bentonite | ||
| 203-376-6 | Citronellal | ||
| 231-753-5 | Iron sulphate | ||
| For the active substance, the information given in this Section shall be sufficient to enable the active substance to be identified. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated | ||
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| If the assessment performed indicates the need to investigate further the degradation of the substance and its degradation products or the active substance has an overall low or absent abiotic degradation, then the tests described in 10.1.3 and 10.3.2 and where appropriate — in 10.4 shall be required. The choice of the appropriate test(s) depends on the results of the initial assessment performed | ||
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| In addition, for each entry, the reasons why no classification is given for an endpoint should be provided | ||
| Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. | ||
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| The test requirements below are applicable only to the relevant components of the biocidal product | ||
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| Example labels, instructions for use and safety data sheets shall be provided | ||
(1) adequacy of the data for the purpose of classification and labelling and risk assessment; (2) sufficient adequate and reliable documentation is provided to assess the equivalency of the study; and (3) the data are valid for the endpoint being investigated and the study is performed using an acceptable level of quality assurance.
(1) adequacy of the data for the purpose of classification and labelling and risk assessment; (2) adequate and reliable coverage of the key parameters/endpoints foreseen to be investigated in the corresponding test methods; (3) exposure duration comparable to or longer than the corresponding test methods if exposure duration is a relevant parameter; (4) adequate and reliable documentation of the study is provided; and (5) the study is performed using a system of quality assurance.
(1) the proper selection and characterisation of the exposed and control groups; (2) adequate characterisation of exposure; (3) sufficient length of follow-up for disease occurrence; (4) valid method for observing an effect; (5) proper consideration of bias and confounding factors; and (6) a reasonable statistical reliability to justify the conclusion.
further testing on vertebrates for that property shall not be undertaken, further testing not involving vertebrates may be omitted.
the results are derived from a (Q)SAR model whose scientific validity has been established, the substance falls within the applicability domain of the (Q)SAR model, the results are adequate for the purpose of classification and labelling and risk assessment, and adequate and reliable documentation of the applied method is provided.
(1) results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles; (2) results are adequate for the purpose of classification and labelling and risk assessment; and (3) adequate and reliable documentation of the applied method is provided. In the case of negative results, these exemptions do not apply. A confirmation test may be requested on a case-by-case basis.
(1) a common functional group indicating the presence of dangerous properties; (2) common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals and indicates the presence of dangerous properties; or (3) a constant pattern in the changing of the potency of the properties across the category.
be adequate for the purpose of classification and labelling and risk assessment, have adequate and reliable coverage of the key parameters addressed in the corresponding test method, and cover an exposure duration comparable to or longer than the corresponding test method if exposure duration is a relevant parameter.
An exposure assessment shall be performed, covering primary and secondary exposure under realistic worst case for all intended uses of the biocidal product that contains the active substance for which approval is applied, or of the biocidal product for which the authorisation is sought. If a new exposure scenario is introduced at a later stage, during the product authorisation process, additional data shall be submitted to assess whether the justification for data adaptation still applies. The reasons why the outcome of the exposure assessment justifies waiving of data requirements shall be clearly and transparently explained.
"Efficacy" corresponds to criterion (i): "is sufficiently effective". "Effects on target organisms" corresponds to criterion (ii): "has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross resistance or unnecessary suffering and pain for vertebrates". "Effects on human and animal health" corresponds to criterion (iii): "has no immediate or delayed unacceptable effects itself, or as a result of its residues, on human health, including that of vulnerable groups See definition of vulnerable groups in Article 3. "Effects on the environment" corresponds to criterion iv: "has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations: its fate and distribution in the environment, contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation, its impact on non-target organisms, its impact on biodiversity and the ecosystem".
(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.
(a) the hazards due to the physico-chemical properties, (b) the risk to humans and animals, (c) the risk to the environment, (d) the measures necessary to protect humans, animals and the environment, both during the proposed normal use of the biocidal product and in a realistic worst-case situation.
acute toxicity, irritation, corrosivity, sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity, reproductive toxicity, neurotoxicity, immunotoxicity, disruption of the endocrine system, any other special properties of the active substance or substance of concern, other effects due to physico-chemical properties.
professional users, non-professional users, humans exposed directly or indirectly via the environment.
adequately measured exposure data, the form in which the biocidal product is marketed, the type of biocidal product, the application method and application rate, the physico-chemical properties of the biocidal product, the likely routes of exposure and potential for absorption, the frequency and duration of exposure, maximum residue levels, the type and size of specific exposed populations, where such information is available.
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.
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, long range environmental transportation.
ISO, CEN or other international standard method national standard method industry standard method (if accepted by the evaluating body) individual producer standard method (if accepted by the evaluating body) data from the actual development of the biocidal product (if accepted by the evaluating body).
(1) that the biocidal product complies with the criteria; (2) that, subject to specific conditions/restrictions, the biocidal product can comply with the criteria; (3) that it is not possible, without additional data, to establish if the biocidal product complies with the criteria; (4) that the biocidal product does not comply with the criteria.
Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policyOJ L 164, 25.6.2008, p. 19 .Directive 2008/105/EC, or international agreements on the protection of river systems or marine waters from pollution.
the maximum permissible concentration laid down by Directive 98/83/EC, or the maximum concentration as laid down following the procedure for approving the active substance under this Regulation, on the basis of appropriate data, in particular toxicological data,
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: Directive 2000/60/EC, Directive 98/83/EC, or
has an impact deemed unacceptable on non-target organisms,
the PEC/PNEC is above 1, or the concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products, has an unacceptable impact on non-target species, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
death is synchronous with the extinction of consciousness, or death occurs immediately, or vital functions are reduced gradually without signs of obvious suffering.
| Directive 98/8/EC | This Regulation |
|---|---|
| — | Article 1 |
| Article 1 | Article 2 |
| Article 2 | Article 3 |
| Article 10 | Article 4 |
| Article 10 | Article 5 |
| — | Article 6 |
| Article 11(1)(a) | 6(1) |
| Article 11(1)(a)(i) and (ii) | 6(2) |
| — | 6(3) |
| — | 6(4) |
| — | Article 7 |
| Article 11(1)(a) | 7(1) |
| — | 7(2) |
| — | 7(3) |
| — | 7(4) |
| — | 7(5) |
| — | 7(6) |
| — | Article 8 |
| Article 11(2), first subparagraph | 8(1) |
| Article 11(2), second subparagraph | 8(2) |
| Article 10(1), first subparagraph | 8(3) |
| — | 8(4) |
| — | Article 9 |
| 11(4) | 9(1) |
| — | 9(2) |
| — | Article 10 |
| Article 33 | Article 11 |
| Article 10(4) | Article 12 |
| — | 12(1) |
| — | 12(2) |
| — | 12(3) |
| — | Article 13 |
| — | Article 14 |
| — | Article 15 |
| — | Article 16 |
| — | Article 17 |
| Article 3(1) | 17(1) |
| Article 8(1) | 17(2) |
| — | 17(3) |
| Article 3(6) | 17(4) |
| Article 3(7) | 17(5) |
| — | 17(6) |
| — | Article 18 |
| — | Article 19 |
| Article 5(1) | 19(1) |
| Article 5(1)(b) | 19(2) |
| — | 19(3) |
| Article 5(2) | 19(4) |
| — | 19(5) |
| Article 2(1)(j) | 19(6) |
| — | 19(7) |
| — | 19(8) |
| — | 19(9) |
| — | Article 20 |
| Article 8(2) | 20(1) |
| Article 8(12) | 20(2) |
| — | 20(3) |
| — | Article 21 |
| — | Article 22 |
| Article 5(3) | 22(1) |
| — | 22(2) |
| — | Article 23 |
| — | 23(1) |
| Article 10(5)(i) | 23(2) |
| — | 23(3) |
| — | 23(4) |
| — | 23(5) |
| — | 23(6) |
| Article 33 | Article 24 |
| — | Article 25 |
| — | Article 26 |
| — | Article 27 |
| — | Article 28 |
| — | Article 29 |
| — | Article 30 |
| — | Article 31 |
| Article 4 | Article 32 |
| — | Article 33 |
| — | Article 34 |
| — | Article 35 |
| Article 4(4) | Article 36 |
| — | Article 37 |
| — | Article 38 |
| — | Article 39 |
| — | Article 40 |
| — | Article 41 |
| — | Article 42 |
| — | Article 43 |
| — | Article 44 |
| — | Article 45 |
| — | Article 46 |
| — | Article 47 |
| Article 7 | Article 48 |
| Article 7 | Article 49 |
| Article 7 | Article 50 |
| — | Article 51 |
| — | Article 52 |
| — | Article 53 |
| — | Article 54 |
| Article 15 | Article 55 |
| Article 17 | Article 56 |
| — | Article 57 |
| — | Article 58 |
| Article 12 | Article 59 |
| — | Article 60 |
| — | 60(1) |
| Article 12(1)(c)(ii) and (1)(b) and (1)(d)(ii) | 60(2) |
| Article 12(2)(c)(i) and (ii) | 60(3) |
| — | Article 61 |
| — | Article 62 |
| — | Article 63 |
| Article 13(2) | 63(1) |
| — | 63(2) |
| — | 63(3) |
| Article 13(1) | Article 64 |
| — | Article 65 |
| Article 24 | 65(1) |
| — | 65(2) |
| Article 24 | 65(3) |
| — | 65(4) |
| — | Article 66 |
| — | 66(1) |
| — | 66(2) |
| — | 66(3) |
| Article 19(1) | 66(4) |
| — | Article 67 |
| — | Article 68 |
| — | Article 69 |
| Article 20(1) and 20(2) | Article 69(1) |
| Article 20(3) | Article 69(2) |
| Article 20(6) | Article 69(2) |
| Article 21, second subparagraph | Article 70 |
| — | Article 71 |
| — | Article 72 |
| Article 22(1), first and second subparagraphs | 72(1) |
| Article 22(1), third subparagraph | 72(2) |
| Article 22(2) | 72(3) |
| — | Article 73 |
| — | Article 74 |
| — | Article 75 |
| — | Article 76 |
| — | Article 77 |
| — | Article 78 |
| — | Article 79 |
| — | Article 80 |
| — | 80(1) |
| Article 25 | 80(2) |
| — | 80(3) |
| Article 26 | Article 81 |
| Article 28 | Article 82 |
| — | Article 83 |
| — | Article 84 |
| Article 29 | Article 85 |
| — | Article 86 |
| — | Article 87 |
| Article 32 | Article 88 |
| — | Article 89 |
| — | Article 90 |
| — | Article 91 |
| — | Article 92 |
| — | Article 93 |
| — | Article 94 |
| — | Article 95 |
| — | Article 96 |
| — | Article 97 |
| Annex IA | Annex I |
| Annex II A, III A and IV A | Annex II |
| Annex II B, III B and IV B | Annex III |
| — | Annex IV |
| Annex V | Annex V |
| Annex VI | Annex VI |