ANNEX IIIINFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS
1.
This Annex sets out the information requirements that shall be included in the dossier for the biocidal product accompanying an application for the approval of an active substance in accordance with point (b) of Article 6(1) and the dossier accompanying an application for the authorisation of a biocidal product in accordance with point (a) of Article 20(1).
2.The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all biocidal products.
With regard to the ADS, the data elements to be provided for a specific biocidal product shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the product, existing data, information which is part of the CDS and the types of products and the exposure patterns related to these uses.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex III table. The general considerations regarding adaptation of information requirements as set out in Annex IV to this Regulation shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates.
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 F7the Agency in accordance with point (e) of Article 77(2) of that Regulation F8. 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.
The relevant calculation methods used for the classification of mixtures as laid down in Regulation (EC) No 1272/2008 shall, where appropriate, be applied in the hazard assessment of the biocidal product. Such calculation methods shall not be used if, in relation to a particular hazard, synergistic and antagonistic effects between the different substances contained in the product are considered likely.
Detailed technical guidance regarding the application of this Annex and the preparation of the dossier is F2to be made available online by the competent authority.
F9The 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
Additional information may need to be submitted if necessary to carry out the evaluation as indicated in Article 29(3) F3....
The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria in Article 19(1)(b) are met.
3.
A detailed and full description of studies conducted and of the methods used shall be included. It is important to ensure that the data available is relevant and is of sufficient quality to fulfil the requirements.
F44
Dossiers must be formatted, prepared and submitted in accordance with the data requirements and guidance as specified by the competent authority.
5.
Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Regulation (EC) No 440/2008. F10Where 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. However, if a method is inappropriate or not described F11in Commission Regulation (EC) No 440/2008,, other methods shall be used which are scientifically appropriate F12... and their appropriateness must be justified in the application. When test methods are applied to nanomaterials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and, where applicable, of the technical adaptations/adjustments that have been made in order to respond to the specific characteristics of these materials.
6.
Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 2010/63/EU and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC or other international standards recognised as being equivalent by the F5competent authority. Tests on physico-chemical properties and safety-relevant substance data should be performed at least according to international standards.
7.
Where testing is done, a detailed quantitative and qualitative description (specification) of the product used for each test and its impurities must be provided.
8.
Where test data exist that have been generated before 17 July 2012 by methods other than those laid down in Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority F6..., on a case-by-case basis, taking into account, among other factors, the need to avoid unnecessary testing.
9.
New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements set out in this Annex when all the other data sources have been exhausted. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided.
TITLE 1CHEMICAL PRODUCTS
Core data set and additional data set for chemical products
Information required to support the authorisation of a biocidal product is listed in the table below.
For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.
F13Column 1 Information required | Column 2 All data is CDS unless indicated as ADS | Column 3 Specific rules for adaption from Column 1 |
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1. APPLICANT | ||
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2. IDENTITY OF THE BIOCIDAL PRODUCT | ||
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3. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES | ||
3.1. Appearance (at 20 °C and 101,3 kPa) | ||
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3.4. Storage stability, stability and shelf-life | ||
3.4.1. Storage stability tests | ||
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3.4.2. Effects on content of the active substance and technical characteristics of the biocidal product | ||
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3.5. Technical characteristics of the biocidal product | ||
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3.6. Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised | ||
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4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS | ||
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4.17. Additional physical indications of hazard | ||
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5. METHODS OF DETECTION AND IDENTIFICATION | ||
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| ADS | |
| ADS | |
| ADS | |
| ADS | |
| ADS | |
| ADS | |
6. EFFECTIVENESS AGAINST TARGET ORGANISMS | ||
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F146.6
The proposed claims for the product and, where claims are made, for treated articles regarding the biocidal properties conferred to the article. | ||
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6.8. Any known limitations on efficacy | ||
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F156.8.2
Observations on undesirable or unintended side-effects on non-target organisms or on objects and material to be protected. | ||
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7. INTENDED USES AND EXPOSURE | ||
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7.10. Exposure data in conformity with Annex VI to this Regulation | ||
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8. TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS | ||
F168.1
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. | |
F178.2
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. | |
F188.3
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. | |
| ADS | Testing on the product/mixture does not need to be conducted if:
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F198.5
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. | |
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| Testing on the mixture of products does not need to be conducted if:
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F208.7
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. | |
| ADS | |
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9. ECOTOXICOLOGICAL STUDIES | ||
F219.1
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. | |
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| ADS | Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment |
9.4. If the biocidal product is in the form of bait or granules the following studies may be required: | ||
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| ADS | |
10. ENVIRONMENTAL FATE AND BEHAVIOUR | ||
The test requirements below are applicable only to the relevant components of the biocidal product | ||
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| ADS | |
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11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT | ||
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11.4. Possibility of destruction or decontamination following release in or on the following: | ||
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12. CLASSIFICATION, LABELLING, AND PACKAGING | ||
As established in point (b) of Article 20(1), proposals including justification for the hazard and precautionary statements in accordance with the provisions set in Directive 1999/45/EC and Regulation (EC) No 1272/2008 must be submitted. Example labels, instructions for use and safety data sheets shall be provided | ||
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Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties. |
TITLE 2MICRO-ORGANISMS
Core data set and additional data set
Information required to support the authorisation of a biocidal product is listed in the table below.
For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.
F22Column 1 Information required | Column 2 All data is CDS unless indicated as ADS | Column 3 Specific rules for adaption from Column 1 |
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1. APPLICANT | ||
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2. IDENTITY OF THE BIOCIDAL PRODUCTS | ||
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F232.3
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. | ||
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3. BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT | ||
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3.2. Appearance (at 20 °C and 101,3 kPa) | ||
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3.5. Storage stability, stability and shelf-life | ||
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3.6. Technical characteristics of the biocidal product | ||
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F243.6.8
Spraying patterns – aerosols | ||
F253.6.9
Other technical characteristics | ||
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3.7. Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered | ||
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4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS | ||
F274.1
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 | ||
F27... | ||
5. METHODS OF DETECTION AND IDENTIFICATION | ||
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| ADS | |
6. EFFECTIVENESS AGAINST TARGET ORGANISM | ||
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6.8. Any other known limitations on efficacy including resistance | ||
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7. INTENDED USES AND EXPOSURE | ||
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7.9. Exposure data | ||
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| Testing on the product/mixture does not need to be conducted if:
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| ADS | |
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| Testing on the product/mixture does not need to be conducted if:
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| Testing on the mixture of products does not need to be conducted if:
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| ADS | |
9. ECOTOXICOLOGICAL STUDIES | ||
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| ADS | Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment |
| ADS | |
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10. ENVIRONMENTAL FATE AND BEHAVIOUR | ||
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| ADS | |
F2810.3
Leaching behaviour or mobility | ADS | |
| ADS | |
11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT | ||
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11.3. Procedures for destruction or decontamination of the biocidal product and its packaging | ||
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12. CLASSIFICATION, LABELLING AND PACKAGING | ||
Example labels, instructions for use and safety data sheets shall be provided | ||
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