ANNEX IISupplementary provisions
ANNEX II Annex III to Regulation (EU) No 528/2012 is amended as follows: (1) the introductory part is amended as follows: (a) the fourth paragraph of point 2 is replaced by the following: ‘For some of the information requirements set out in this Annex, it may be possible to satisfy these requirements based on available information of the properties of the active substance(s) contained in the product and the properties of non-active substance(s) included in the product. For non-active substances, applicants shall use the information provided to them in the context of Title IV of Regulation (EC) No 1907/2006, where relevant, and the information made available by the Agency in accordance with point (e) of Article 77(2) of that Regulation. However, the information may be not sufficient or adequate to determine whether a non-active substance contained in a biocidal product has hazardous properties and the evaluating body may conclude that further data are required.’; (b) the seventh paragraph of point 2 is replaced by the following: ‘The applicant shall initiate a pre-submission consultation with the prospective evaluating body. In addition to the obligation set out in Article 62(2), the applicant may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out. The applicant shall document such pre-submission consultations and their outcomes and shall include the relevant documents in the application.’; (c) point 5 is replaced by the following: ‘5. Tests submitted for the purpose of authorisation shall be conducted in accordance with the methods described in Commission Regulation (EC) No 440/2008, or any revised version of these methods not yet included in that Regulation. However, if a method is inappropriate or not described in Commission Regulation (EC) No 440/2008, ( *1 ) other methods shall be used which are scientifically appropriate and their appropriateness shall be justified in the application. When test methods are applied to nano-materials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of these materials. ( *1 ) Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( OJ L 142, 31.5.2008, p. 1 ).’;" (2) the table in Title 1 is amended as follows: (a) the heading of the third column is replaced by the following: ‘Column 3 Specific rules for adaptation from column 1’ (b) row 6.6 is replaced by the following: ‘6.6 The proposed claims for the product and, where claims are made, for treated articles regarding the biocidal properties conferred to the article’ (c) row 6.8.2 is replaced by the following: ‘6.8.2 Observations on undesirable or unintended side-effects on non-target organisms or on objects and material to be protected’ (d) Rows 8.1, 8.2 and 8.3 are replaced by the following: ‘8.1 Skin corrosion or irritation The assessment shall comprise the following tiers: (a) assessment of the available human, animal and non-animal data; (b) skin corrosion, in vitro testing; (c) skin irritation, in vitro testing; (d) skin corrosion or irritation, in vivo testing Testing of the product or mixture does not need to be conducted if: — there are sufficient valid data on each component of the product or mixture to allow its classification in accordance with Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected, — the product or mixture is a strong acid (pH≤ 2,0) or base (pH≥ 11,5), — the product or mixture is spontaneously flammable in air or in contact with water or moisture at room temperature, — the product or mixture meets the classification criteria for acute toxicity category 1 by the dermal route, or — an acute toxicity study by the dermal route provides conclusive evidence on skin corrosion or irritation adequate for classification. If results from one of the two studies listed in points (b) or (c) in column 1 of this row already allow conclusive decision on the classification of product or mixture or on the absence of skin irritation potential, the second study does not need to be conducted An in vivo study for skin corrosion or irritation shall be considered only if the in vitro studies listed in points (b) and (c) in column 1 of this row are not applicable, or the results of these studies are not adequate for classification and risk assessment and the calculation method or bridging principles laid down in Regulation (EC) No 1272/2008 are not applicable In vivo studies for skin corrosion or irritation that were carried out or initiated before 15 April 2022 shall be considered appropriate to address this information requirement 8.2 Serious eye damage or eye irritation The assessment shall comprise the following tiers: (a) assessment of the available human, animal and non-animal data; (b) serious eye damage or eye irritation, in vitro testing; (c) serious eye damage or eye irritation, in vivo testing Testing on the product or mixture does not need to be conducted if: — there are sufficient valid data available on each component of the product or mixture to allow its classification in accordance with Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected, — the product or mixture is a strong acid (pH≤ 2,0) or base (pH≥ 11,5), — the product or mixture is spontaneously flammable in air or in contact with water or moisture at room temperature, or — the product or mixture meets the classification criteria for skin corrosion leading to its classification as “serious eye damage” category 1 If results from a first in vitro study do not allow a conclusive decision on the classification of the product or mixture or on the absence of eye irritation potential (an)other(s) in vitro study(ies) for this endpoint shall be considered An in vivo study for serious eye damage or eye irritation shall be considered only if the in vitro study(ies) under point (b) in column 1 of this row are not applicable, or the results obtained from these studies are not adequate for classification and risk assessment and the calculation method or bridging principles laid down in Regulation (EC) No 1272/2008 are not applicable In vivo studies for serious eye damage or eye irritation that were carried out or initiated before 15 April 2022 shall be considered appropriate to address this information requirement 8.3 Skin sensitisation The information shall allow to conclude whether the substance is a skin sensitiser and whether it can be presumed to have the potential to produce significant sensitisation in humans (Category 1A). The information should be sufficient to perform a risk assessment where required The assessment shall comprise the following tiers: (a) assessment of the available human, animal and non-animal data; (b) skin sensitisation, in vitro testing. Information from in vitro or in chemico test method(s) conducted in accordance with point 5 of the introductory part of this Annex and addressing each of the following key events of skin sensitisation: (i) molecular interaction with skin proteins; (ii) inflammatory response in keratinocytes; (iii) activation of dendritic cells. (c) skin sensitisation in vivo testing. The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Another skin sensitisation test may only be used in exceptional circumstances. If another skin sensitisation test is used, scientific justification shall be provided. Testing on the product or mixture does not need to be conducted if: — there are sufficient valid data available on each component of the product or mixture to allow its classification in accordance with Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected, — the available information indicates that the product or mixture should be classified for skin sensitisation or skin corrosion, — the product or mixture is a strong acid (pH≤ 2,0) or base (pH≥ 11,5), or — the product or mixture is spontaneously flammable in air or in contact with water or moisture at room temperature. In vitro tests do not need to be conducted if: — an in vivo study referred to in point (c) in column 1 of this row is available, or — the available in vitro or in chemico test methods are not applicable for the product or mixture or the results obtained from these studies are not adequate for classification and risk assessment. If information from test method(s) addressing one or two of the key events described in point (b) in column 1 of this row already allows for classification of the substance and risk assessment, studies addressing the other key event(s) do not need to be conducted An in vivo study for skin sensitisation shall be considered only if in vitro or in chemico studies referred to in point (b) in column 1 of this row are not applicable, or the results obtained from these studies are not adequate for classification and risk assessment and the calculation method or bridging principles laid down in Regulation (EC) No 1272/2008 are not applicable In vivo studies for skin sensitisation that were carried out or initiated before 15 April 2022 shall be considered appropriate to address this information requirement’ (e) row 8.7 is replaced by the following: ‘8.7 Available toxicological data relating to: (a) non-active substance(s) (i.e. substance(s) of concern); and (b) a mixture that a substance(s) of concern is a component of Tests listed in Section 8 of the table in Title 1 of Annex II shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of if insufficient data are available and cannot be inferred through read-across, in silico or other accepted non-testing approaches Testing on the product or mixture does not need to be conducted if all of the following conditions are met: — there are valid data available on each of the components in the mixture to allow classification of the mixture in accordance with the rules laid down in Regulation (EC) No 1272/2008, — a conclusion can be made whether the biocidal product can be considered as having endocrine disrupting properties, — synergistic effects between any of the components are not expected’ (f) row 9.1 is replaced by the following: ‘9.1 Available ecotoxicological data relating to: (a) non-active substance(s) (i.e. substance(s) of concern); (b) a mixture that a substance(s) of concern is a component of Tests listed in Section 9 of Title 1 of Annex II shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of if insufficient data are available and cannot be inferred through read-across, in silico or other accepted non-testing approaches Testing on the product or mixture does not need to be conducted if all the following conditions are met: — there are valid data available on each of the components in the mixture to allow classification of the mixture in accordance with the rules laid down in Regulation (EC) No 1272/2008, — a conclusion can be made whether the biocidal product can be considered as having endocrine disrupting properties, — synergistic effects between any of the components are not expected.’ (3) the table in Title 2 is amended as follows: (a) the heading of the third column is replaced by the following: ‘Column 3 Specific rules for adaptation from column 1’ (b) row 2.3 is replaced by the following: ‘2.3 Detailed quantitative (g/kg, g/l, % w/w (v/v), cfu/g, cfu/l or IU/mg or any other appropriate unit) and qualitative information on the constitution, composition and function of the biocidal product, e.g. micro-organism, active substance(s) and non-active substances and any other relevant components All relevant information on individual ingredients and the final composition of the biocidal product shall be given’ (c) rows 3.6.8 to 3.6.12 are deleted (d) the following rows 3.6.8 and 3.6.9 are inserted: ‘3.6.8 Spraying patterns – aerosols 3.6.9 Other technical characteristics’ (e) rows 4 to 4.12.3 are replaced by the following 4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS ‘4.1. Explosives 4.2. Flammable aerosols 4.3. Flammable liquids 4.4. Flammable solids 4.5. Oxidising liquids 4.6. Oxidising solids 4.7. Corrosive to metals 4.8. Other physical indications of hazard 4.8.1. Auto-ignition temperatures of products (liquids and gases) 4.8.2. Relative self-ignition temperature for solids 4.8.3. Dust explosion hazard’ (f) row 10.3 is replaced by the following: ‘10.3 Leaching behaviour and/or mobility ADS’ ( *1 ) Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( OJ L 142, 31.5.2008, p. 1 ).’;’