The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024

1.—(1) Annex 3 to Regulation (EU) No 528/2012 (Information Requirements for Biocidal Products) is amended as follows.

(2) In Point 2, paragraph 4—

(a) for “competent authority” substitute “the Agency”.

(b) at the end, insert “. However, the information may not be sufficient or adequate to determine whether or not a non-active substance contained in a biocidal product has hazardous properties and the competent authority may conclude that further data are required”.

(3) In Point 2, for the seventh paragraph, substitute—

“The applicant must initiate a pre-submission consultation with the competent authority. In addition to the obligation set out in Article 62(2), the applicant may also consult with the competent authority with regard to the proposed information requirements and in particular the strategy for avoiding new testing on vertebrates alongside any testing on vertebrates that the applicant proposes to carry out. The applicant must document such pre-submission consultations and their outcomes and must include the relevant documents in the application”.

(4) In Point 5—

(a) after “Regulation (EC) No 440/2008.”, insert “Where a revised version of a test method described in Commission Regulation (EC) No 440/2008 is available, but not included in that Regulation, the revised version may be used with the agreement of the competent authority.”.

(b) after “…if a method is inappropriate or not described”, insert “in Commission Regulation (EC) No 440/2008,”.

(c) omit “, whenever possible internationally recognised,”.

(5) In the TITLE 1 (Chemical Products) table—

(a) For the first row, substitute—

“Column 1 Information required

Column 2 All data is CDS unless indicated as ADS

Column 3 Specific rules for adaption from Column 1”.

(b) For row 6.6, substitute—

“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) For row 6.8.2, substitute—

“6.8.2    Observations on undesirable or unintended side-effects on non-target organisms or on objects and material to be protected.”.

(d) For row 8.1, substitute—

“8.1    Skin corrosion or irritation.    The assessment must 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 a 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 must not be conducted unless 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.    In vivo studies for skin corrosion or irritation that were initiated before 6th October 2025 will be considered appropriate to address this information requirement only if they lead to a more severe classification than the calculation method of Regulation (EC) No 1272/2008.”.

(e) For row 8.2, substitute—

“8.2    Serious eye damage or eye irritation.    The assessment must 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, other in vitro studies for this endpoint must be considered.    An in vivo study for serious eye damage or eye irritation must not be conducted unless the in vitro studies 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.    In vivo studies for serious eye damage or eye irritation that were initiated before 6th October 2025 will be considered appropriate to address this information requirement only if they lead to a more severe classification than the calculation method of Regulation (EC) No 1272/2008.”.

(f) For row 8.3, substitute—

“8.3    Skin sensitisation.    The information must allow a conclusion as to 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 must comprise the following tiers:    (a) assessment of the available human, animal and non-animal data;    (b) skin sensitisation, in vitro testing according to OECD TG 497;    (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 must 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 of OECD TG 497 are not applicable for the product or mixture or the results obtained from these studies are not adequate for classification and risk assessment.    An in vivo study for skin sensitisation must not be conducted unless the in vitro or in chemico studies of OECD TG 497 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 initiated before 6th October 2025 will be considered appropriate to address this information requirement.”.

(g) For row 8.5, substitute—

“8.5    Acute toxicity.    Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach and should include an assessment of information from in silico approaches.

Testing on the product/mixture does not need to be conducted if:    - there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Regulation (EC) No 1272/2008, and synergistic effects between any of the components are not expected.”.

(h) For row 8.7, substitute—

“8.7    Available toxicological data relating to:    (a) a non-active substance or substances (i.e. substance or substances of concern);    (b) a mixture containing a substance or substances of concern.    Targeted tests listed in Section 8 of the table in Title 1 of Annex 2 must be carried out, with consideration of reduction of animal use, for the substance or substances of concern or a mixture containing a substance or substances of concern 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 as to whether the biocidal product can be considered as having endocrine disrupting properties;    - synergistic effects between any of the components are not expected.”.

(i) For row 9.1, substitute—

“9.1    Available ecotoxicological data relating to:    (a) a non-active substance or substances (i.e. substance or substances of concern);    (b) a mixture containing a substance or substances of concern.    Tests listed in Section 9 of Title 1 of Annex 2 must be carried out for the substance or substances of concern or a mixture containing a substance or substances of concern 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 as to whether the biocidal product can be considered as having endocrine disrupting properties;    - synergistic effects between any of the components are not expected.”.

(6) In the TITLE 2 (Micro-organisms) table—

(a) For the first row, substitute—

“Column 1 Information required

Column 2 All data is CDS unless indicated as ADS

Column 3 Specific rules for adaption from Column 1”.

(b) For row 2.3, substitute—

“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 substances and non-active substances and any other relevant components.    All relevant information on individual ingredients and the final composition of the biocidal product must be given.”.

(c) For row 3.6.8, substitute—

“3.6.8    Spraying patterns – aerosols”.

(d) For row 3.6.9, substitute—

“3.6.9    Other technical characteristics”.

(e) Omit rows 3.6.10 to 3.6.12.

(f) For rows 4.1 to 4.12.3, substitute—

“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”.

(g) For row 10.3, substitute—

“10.3    Leaching behaviour or mobility

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