F3ANNEX I
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ANNEX IIINFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES
1.
This Annex sets out the information requirements for the preparation of the dossier referred to in point (a) of Article 6(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 active substances. However, in some cases the physical or chemical properties of the substance may mean that it is impossible or unnecessary to provide specific data elements belonging to the CDS.
With regard to the ADS, the data elements to be provided for a specific active substance 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 substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used 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 II table. The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates. The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in Article 4(1) are met.
The applicant should consult the detailed technical guidance regarding the application of this Annex and the preparation of the dossier referred to in point (a) of Article 6(1), which is F4to be made available online by the competent authority.
The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set down in Article 62(2), applicants may also consult with the competent authority F5... with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out.
Additional information may need to be submitted if it is necessary to carry out the evaluation as indicated in Article 8(2).
3.
A detailed and full description of the studies conducted or referred to 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. Evidence should also be provided to demonstrate that the active substance upon which the tests have been carried out is the same as the substance for which the application has been submitted.
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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 the approval of an active substance shall be conducted according to the methods described in 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)60. However, if a method is inappropriate or not described, other methods shall be used which are scientifically appropriate, whenever possible internationally recognised, 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 of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes61 and in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances62 or other international standards recognised as being equivalent by the F7competent 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 description (specification) of the active substance used and its impurities must be provided. Testing should be performed with the active substance as manufactured or, in the case of some of the physical and chemical properties (see indications given in column I of the table), with a purified form of the active substance.
8.
Where test data exist that have been generated before 1 September 2013 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 F8..., on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrates.
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 SUBSTANCES
Core data set and additional data set for active substances
Information required to support the approval of an active substance is listed in the table below.
Conditions for not requiring a specific test that are set out in the appropriate test methods in the Regulation (EC) No 440/2008 and are not repeated in column 3, also apply.
Column 1Information required | Column 2All data is CDS unless indicated as ADS | Column 3Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
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1. APPLICANT | ||
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2. IDENTITY OF THE ACTIVE SUBSTANCE | ||
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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3. PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE | ||
3.1. Appearance63 | ||
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3.7. Vapour pressure64 | ||
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| ADS | |
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4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS | ||
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4.17. Additional physical indicators for hazards | ||
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5. METHODS OF DETECTION AND IDENTIFICATION | ||
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5.2. Analytical methods for monitoring purposes including recovery rates and the limits of quantification and detection for the active substance, and for residues thereof in/on the following where relevant | ||
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| ADS | |
6. EFFECTIVENESS AGAINST TARGET ORGANISMS | ||
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6.7. Any known limitations on efficacy | ||
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7. INTENDED USES AND EXPOSURE | ||
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7.6. Exposure data in conformity with Annex VI to this Regulation | ||
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8. TOXICOLOGICAL PROFILE FOR HUMAN AND ANIMAL INCLUDING METABOLISM | ||
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| Step 2 does not need to be conducted if:
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| ADS | |
8.5. Mutagenicity | ||
The assessment of this endpoint shall comprise the following consecutive steps:
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| ADS | The study/ies do(es) not generally need to be conducted if:
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| The study/ies do(es) not generally need to be conducted if:
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| The study need not be conducted if:
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8.8. Toxicokinetics and metabolism studies in mammals | ||
The toxicokinetics and metabolism studies should provide basic data about the rate and extent of absorption, the tissue distribution and the relevant metabolic pathway including the degree of metabolism, the routes and rate of excretion and the relevant metabolites | ||
| ADS | |
| The repeated dose toxicity study (28 or 90 days) does not need to be conducted if:
In order to reduce testing carried out on vertebrates and in particular the need for free-standing single-endpoint studies, the design of the repeated dose toxicity studies shall take account of the possibility to explore several endpoints within the framework of one study | |
| The short-term toxicity study (28 days) does not need to be conducted if:
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| The sub-chronic toxicity study (90 days) does not need to be conducted if:
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| The long-term toxicity study (≥ 12 months) does not need to be conducted if:
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| ADS | |
| The studies need not be conducted if:
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| ADS | |
| A carcinogenicity study does not need to be conducted if:
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8.12. Relevant health data, observations and treatments | ||
Justification should be provided if data is not available | ||
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| ADS | |
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9. ECOTOXICOLOGICAL STUDIES | ||
9.1. Toxicity to Aquatic Organisms | ||
| The study does not need to be conducted if:
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9.1.2. Short-term toxicity testing on aquatic invertebrates | ||
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9.1.3. Growth inhibition study on algae | ||
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| The experimental determination may not need to be carried out if:
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| ADS | |
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| ADS | For endpoint 9.4.3 the study does not need to be conducted if:
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| ADS | |
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| ADS | Data are derived from the mammalian toxicological assessment. The most sensitive relevant mammalian long-term toxicological endpoint (NOAEL) expressed as mg test compound/kg bw/day shall be reported |
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10. ENVIRONMENTAL FATE AND BEHAVIOUR | ||
10.1. Fate and behaviour in water and sediment | ||
10.1.1. Degradation, initial studies | ||
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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10.1.3. Rate and route of degradation including identification of metabolites and degradation products | ||
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10.3. Fate and behaviour in air | ||
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11. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT | ||
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12. CLASSIFICATION, LABELLING AND PACKAGING | ||
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12.2. The hazard classification of the substance resulting from the application of Regulation (EC) No 1272/2008 | ||
In addition, for each entry, the reasons why no classification is given for an endpoint should be provided | ||
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The information provided should be for the purified active substance of stated specification or for the active substance as manufactured, if different. | ||
The information provided should be for the purified active substance of stated specification. | ||
TITLE 2MICRO-ORGANISMS
Core data set and additional data set for active substances
Information required to support the approval of an active substance is listed in the table below.
Conditions for not requiring a specific test that are set out in the appropriate test methods in Regulation (EC) No 440/2008 that are not repeated in column 3, also apply.
Column 1Information required | Column 2All data is CDS unless indicated as ADS | Column 3Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
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1. APPLICANT | ||
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2. IDENTITY OF THE MICRO-ORGANISM | ||
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3. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM | ||
3.1. General information on the micro-organism | ||
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4. METHODS OF DETECTION AND IDENTIFICATION | ||
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5. EFFECTIVENESS AGAINST TARGET ORGANISM | ||
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5.8. Any known limitations on efficacy | ||
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6. INTENDED USES AND EXPOSURE | ||
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6.5. Exposure data applying, as appropriate, the methodologies described in Section 5 of Annex I to Regulation (EC) No 1907/2006 | ||
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| Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. | |
7.1. Basic information | ||
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7.2. Basic studies | ||
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7.2.2. Acute toxicity, pathogenicity, and infectiveness | ||
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| ADS | |
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| ADS | |
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| Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. | |
8.1. Effects on aquatic organisms | ||
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9. ENVIRONMENTAL FATE AND BEHAVIOUR | ||
9.1. Persistence and multiplication | ||
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10. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT | ||
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11. CLASSIFICATION, LABELLING AND PACKAGING OF THE MICRO-ORGANISM | ||
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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 the F9competent authority in accordance with point (e) of Article 77(2) of that Regulation.
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 F10to be made available online by the competent authority.
The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set out in Article 62(2), applicants may also consult with the competent authority F11... with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out.
Additional information may need to be submitted if necessary to carry out the evaluation as indicated in Article 29(3) F12....
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.
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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. However, if a method is inappropriate or not described, other methods shall be used which are scientifically appropriate, whenever possible internationally recognised, 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 F14competent 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 F15..., 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.
Column 1Information required: | Column 2All data is CDS unless indicated as ADS | Column 3Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
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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 | |
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| ADS | |
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6. EFFECTIVENESS AGAINST TARGET ORGANISMS | ||
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6.8. Any known limitations on efficacy | ||
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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 | ||
| Testing on the product/mixture does not need to be conducted if:
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| Testing on the product/mixture does not need to be conducted if:
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| Testing on the product/mixture does not need to be conducted if:
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| ADS | Testing on the product/mixture does not need to be conducted if:
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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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| Testing on the product/mixture does not need to be conducted if:
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| ADS | |
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| ADS | |
| 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 |
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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| ADS | |
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.
Column 1Information required: | Column 2All data is CDS unless indicated as ADS | Column 3Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
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1. APPLICANT | ||
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2. IDENTITY OF THE BIOCIDAL PRODUCTS | ||
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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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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 | ||
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4.12. Other physical indications of hazard | ||
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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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| ADS | |
10. ENVIRONMENTAL FATE AND BEHAVIOUR | ||
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| ADS | |
| 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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ANNEX IVGENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS
This Annex sets out rules to be followed when the applicant proposes to adapt the data requirements set out in Annexes II and III in accordance with Article 6(2) and (3) or Article 21(1) and (2), without prejudice to the specific rules set out in Annex III on the use of the calculation methods for classification of mixtures to avoid testing on vertebrates.
The reasons for such adaptations to the data requirements must be clearly stated under the appropriate heading of the dossier referring to the specific rule(s) of this Annex.
1.TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY
1.1.Use of existing data
1.1.1.
Data on physical-chemical properties from experiments not carried out according to GLP or the relevant test methods.
Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met:
- (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.
1.1.2.
Data on human health and environmental properties from experiments not carried out according to GLP or the relevant test methods.
Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met:
- (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.
1.1.3.Historical human data
As a general rule, in accordance with Article 7(3) of Regulation (EC) No 1272/2008, tests on humans shall not be performed for the purposes of this Regulation. However, existing historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data, biomonitoring studies, clinical studies and human volunteer studies performed in accordance with internationally accepted ethical standards shall be considered.
Data collected on humans shall not be used to lower the safety margins resulting from tests or studies on animals.
The strength of the data for a specific human health effect depends, among other things, on the type of analysis and the parameters covered, and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:
- (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.
In all cases adequate and reliable documentation shall be provided.
1.2.Weight of evidence
There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or does not have a particular dangerous property, while the information from each single source alone is considered insufficient to support this notion. There may be sufficient weight of evidence from the use of positive results of newly developed test methods, not yet included in the relevant test methods or from an international test method recognised by the F16competent authority as being equivalent, leading to the conclusion that a substance has a particular dangerous property. However, if the newly developed test method has been approved by the F16competent authority, but has not yet been published, its results may be taken into account even where this leads to the conclusion that a substance does not have a particular dangerous property.
Where consideration of all the available data provides sufficient weight of evidence for the presence or absence of a particular dangerous property:
further testing on vertebrates for that property shall not be undertaken,
further testing not involving vertebrates may be omitted.
In all cases adequate and reliable documentation shall be provided.
1.3.Qualitative or Quantitative structure-activity relationship ((Q)SAR)
Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence, but not the absence of a given dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:
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.
F17...
1.4.In vitro methods
Results obtained from suitable in vitro methods may indicate the presence of a given dangerous property or may be important in relation to a mechanistic understanding, which may be important for the assessment. In this context, ‘suitable’ means sufficiently well-developed according to internationally agreed test development criteria.
Where such in vitro tests are positive, it is necessary to confirm the dangerous property by adequate in vivo tests. However, such confirmation may be waived if the following conditions are met:
- (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.
1.5.Grouping of substances and read-across approach
Substances whose physico-chemical, toxicological and ecotoxicological properties are similar or follow a regular pattern as a result of structural similarity may be considered as a group or ‘category’ of substances. Application of the group concept requires that physico-chemical properties, human and animal health effects, and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint.
The similarities may be based on:
- (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.
If the group concept is applied, substances shall be classified and labelled on this basis.
In all cases results shall:
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.
In all cases, adequate and reliable documentation of the applied method shall be provided.
F18...
2.TESTING IS TECHNICALLY NOT POSSIBLE
Testing for a specific endpoint may be omitted if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion, or the radio-labelling of the substance required in certain studies may not be possible. The guidance given in the relevant test methods, more specifically on the technical limitations of a specific method, shall always be respected.
3.PRODUCT-TAILORED EXPOSURE-DRIVEN TESTING
3.1.
Testing in accordance with some endpoints in Sections 8 and 9 of Annexes II and III, notwithstanding Article 6(2), may be omitted based on exposure considerations, where exposure data in accordance with Annex II or III are available.
In that case, the following conditions shall be met:
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.
However, testing cannot be omitted for non-threshold effects. As a consequence, certain core data shall always be obligatory, e.g. genotoxicity testing.
F19...
3.2.
In all cases, adequate justification and documentation shall be provided. The justification shall be based on an exposure assessment, in accordance with the relevant Technical Notes for Guidance where available.
ANNEX VBIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)
MAIN GROUP 1:Disinfectants
These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.
Product-type 1:Human hygiene
Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.
Product-type 2:Disinfectants and algaecides not intended for direct application to humans or animals
Products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs.
Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities.
Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil.
Products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials.
Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.
Product-type 3:Veterinary hygiene
Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function.
Products used to disinfect the materials and surfaces associated with the housing or transportation of animals.
Product-type 4:Food and feed area
Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.
F1Products used to be incorporated into materials which may enter into contact with food.
Product-type 5:Drinking water
Products used for the disinfection of drinking water for both humans and animals.
MAIN GROUP 2:Preservatives
Unless otherwise stated these product-types include only products to prevent microbial and algal development.
Product-type 6:Preservatives for products during storage
Products used for the preservation of manufactured products, other than foodstuffs, feedingstuffs, cosmetics or medicinal products or medical devices by the control of microbial deterioration to ensure their shelf life.
Products used as preservatives for the storage or use of rodenticide, insecticide or other baits.
Product-type 7:Film preservatives
Products used for the preservation of films or coatings by the control of microbial deterioration or algal growth in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works.
Product-type 8:Wood preservatives
Products used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms, including insects.
This product-type includes both preventive and curative products.
Product-type 9:Fibre, leather, rubber and polymerised materials preservatives
Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products by the control of microbiological deterioration.
This product-type includes biocidal products which antagonise the settlement of micro-organisms on the surface of materials and therefore hamper or prevent the development of odour and/or offer other kinds of benefits.
Product-type 10:Construction material preservatives
Products used for the preservation of masonry, composite materials, or other construction materials other than wood by the control of microbiological, and algal attack.
Product-type 11:Preservatives for liquid-cooling and processing systems
Products used for the preservation of water or other liquids used in cooling and processing systems by the control of harmful organisms such as microbes, algae and mussels.
Products used for the disinfection of drinking water or of water for swimming pools are not included in this product-type.
Product-type 12:Slimicides
Products used for the prevention or control of slime growth on materials, equipment and structures, used in industrial processes, e.g. on wood and paper pulp, porous sand strata in oil extraction.
Product-type 13:Working or cutting fluid preservatives
Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.
MAIN GROUP 3:Pest control
Product-type 14:Rodenticides
Products used for the control of mice, rats or other rodents, by means other than repulsion or attraction.
Product-type 15:Avicides
Products used for the control of birds, by means other than repulsion or attraction.
Product-type 16:Molluscicides, vermicides and products to control other invertebrates
Products used for the control of molluscs, worms and invertebrates not covered by other product-types, by means other than repulsion or attraction.
Product-type 17:Piscicides
Products used for the control of fish, by means other than repulsion or attraction.
Product-type 18:Insecticides, acaricides and products to control other arthropods
Products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction.
Product-type 19:Repellents and attractants
Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds, fish, rodents), by repelling or attracting, including those that are used for human or veterinary hygiene either directly on the skin or indirectly in the environment of humans or animals.
Product-type 20:Control of other vertebrates
Products used for the control of vertebrates other than those already covered by the other product-types of this main group, by means other than repulsion or attraction.
MAIN GROUP 4:Other biocidal products
Product-type 21:Antifouling products
Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water.
Product-type 22:Embalming and taxidermist fluids
Products used for the disinfection and preservation of human or animal corpses, or parts thereof.
ANNEX VICOMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS
TERMS AND DEFINITIONS
Correspondence with the criteria set out in Article 19(1)(b)
The subheadings ‘Effects on human and animal health’, ‘Effects on the Environment’, ‘Effects on Target Organisms’ and ‘Efficacy’ used in the Sections ‘Assessment’ and ‘Conclusions’ correspond to the four criteria set out in Article 19(1)(b) as follows:
‘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 groups69, or animal health, directly or through drinking water, food, feed, air, or through other indirect effects’.
‘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’.
Technical definitions
(a)Hazard identification
The identification of the adverse effects which a biocidal product has an inherent capacity to cause.
(b)Dose (concentration) — response (effect) assessment
The estimate of the relationship between the dose, or level of exposure, of an active substance or substance of concern in a biocidal product and the incidence and severity of an effect.
(c)Exposure assessment
The determination of the emissions, pathways and rates of movement of an active substance or a substance of concern in a biocidal product and its transformation or degradation in order to estimate the concentration/doses to which human populations, animals or environmental compartments are or may be exposed.
(d)Risk characterisation
The estimation of the incidence and severity of the adverse effects likely to occur in a human population, animals or environmental compartments due to actual or predicted exposure to any active substance or substance of concern in a biocidal product. This may include ‘risk estimation’, i.e. the quantification of that likelihood.
(e)Environment
Water, including sediment, air, soil, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms.
INTRODUCTION
1.
This Annex sets out the common principles for the evaluation of dossiers for biocidal products referred to in Article 19(1)(b). A decision by F20the competent authority to authorise a biocidal product shall be taken on the basis of the conditions set down in Article 19, taking account of the evaluation carried out according to this Annex. Detailed technical guidance regarding the application of this Annex is F21to be made available online by the competent authority.
2.
The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances. For biocidal products containing micro-organisms, these principles should be further developed in technical guidance taking into account practical experience gained, and be applied taking into account the nature of the product and the latest scientific information. In the case of biocidal products containing nanomaterials, the principles set out in this Annex will also need to be adapted and elaborated in technical guidance to take account of the latest scientific information.
3.
In order to ensure a high and harmonised level of protection of human health, animal health and the environment, any risks arising from the use of a biocidal product shall be identified. To achieve this, a risk assessment shall be carried out to determine the acceptability or otherwise of any risks that are identified. This is done by carrying out an assessment of the risks associated with the relevant individual components of the biocidal product, taking into account any cumulative and synergistic effects.
4.
A risk assessment on the active substance(s) present in the biocidal product is always required. This risk assessment shall entail hazard identification, and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation. Where a quantitative risk assessment cannot be made a qualitative assessment shall be produced.
5.
Additional risk assessments shall be carried out, in the same manner as described above, on any substance of concern present in the biocidal product. Information submitted in the framework of Regulation (EC) No 1907/2006 shall be taken into account where appropriate.
6.
In order to carry out a risk assessment, data are required. These data are detailed in Annexes II and III and take account of the fact that there are a wide variety of applications as well as different product-types and that this has an impact on the associated risks. The data required shall be the minimum necessary to carry out an appropriate risk assessment. The F22competent authority shall take due consideration of the requirements of Articles 6, 21 and 62 in order to avoid duplication of data submissions. Data may also be required on a substance of concern present in a biocidal product. For in-situ generated active substances, the risk assessment includes also the possible risks from the precursor(s).
7.
The results of the risk assessments carried out on the active substance and on the substances of concern present in the biocidal product shall be integrated to produce an overall assessment for the biocidal product itself.
8.
When making evaluations of a biocidal product the F23competent authority shall:
- (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.
9.
The application of these common principles shall, when taken together with the other conditions set out in Article 19, lead to the F24competent authority or the Secretary of State deciding whether or not a biocidal product can be authorised. Such authorisation may include restrictions on use or other conditions. In certain cases the F25competent authority may conclude that more data are required before an authorisation decision can be made.
10.
In the case of biocidal products containing active substances covered by the exclusion criteria in Article 5(1), the competent F26authority shall also evaluate whether the conditions of Article 5(2) can be satisfied.
11.
During the process of evaluation, applicants and the F27competent authority shall cooperate in order to resolve quickly any questions on the data requirements, to identify at an early stage any additional studies required, to amend any proposed conditions for the use of the biocidal product, or to modify its nature or its composition in order to ensure full compliance with the requirements of Article 19 and of this Annex. The administrative burden, especially for SMEs, shall be kept to the minimum necessary without prejudicing the level of protection afforded to humans, animals and the environment.
12.
The judgments made by the F28competent authority during the evaluation must be based on scientific principles, preferably recognised at international level, and must be made with the benefit of expert advice.
ASSESSMENT
General principles
13.
The data submitted in support of an application for authorisation of a biocidal product shall be validated by the F29... competent authority in accordance with the relevant articles of the Regulation. After validation of these data the F30competent authority shall utilise them by carrying out a risk assessment based on the proposed use. Information submitted in the framework of Regulation (EC) No 1907/2006 shall be taken into account where appropriate.
14.
A risk assessment on the active substance present in the biocidal product shall always be carried out. If there are, in addition, any substances of concern present in the biocidal product then a risk assessment shall be carried out for each of these. The risk assessment shall cover the proposed normal use of the biocidal product, together with a realistic worst-case scenario including any relevant production and disposal issue. The assessment shall also take account of how any ‘treated articles’ treated with or containing the product may be used and disposed of. Active substances that are generated in-situ and the associated precursors shall also be considered.
15.
In carrying out the assessment, the possibility of cumulative or synergistic effects shall also be taken into account. F31...
16.
For each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail hazard identification and the establishment of appropriate reference values for dose or effect concentrations such as NOAEL or Predicted No Effect Concentrations (PNEC), where possible. It shall also include, as appropriate, a dose (concentration) — response (effect) assessment, together with an exposure assessment and a risk characterisation.
17.
The results arrived at from a comparison of the exposure to the appropriate reference values for each of the active substances and for any substances of concern shall be integrated to produce an overall risk assessment for the biocidal product. Where quantitative results are not available the results of the qualitative assessments shall be integrated in a similar manner.
18.The risk assessment shall determine:
- (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.
19.
In certain cases it may be concluded that further data are required before a risk assessment can be finalised. Any such additional data requested shall be the minimum necessary to complete such a risk assessment.
20.
The information provided on the biocidal product family shall permit the F32competent authority to reach a decision on whether all the products within the biocidal product family comply with the criteria under Article 19(1)(b).
21.
Where relevant the technical equivalence for every active substance contained in the biocidal product shall be established with reference to active substances already included in the list of approved active substances.
Effects on human and animal health
Effects on human health
22.
The risk assessment shall take account of the following potential effects arising from the use of the biocidal product and the populations liable to exposure.
23.The effects previously mentioned result from the properties of the active substance and any substance of concern present. They are:
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.
24.The populations previously mentioned are:
professional users,
non-professional users,
humans exposed directly or indirectly via the environment.
In considering these populations, particular attention should be given to the need to protect vulnerable groups within these populations.
25.
The hazard identification shall address the properties and potential adverse effects of the active substance and any substances of concern present in the biocidal product.
26.
The F33competent authority shall apply points 27 to 30 when carrying out a dose (concentration) - response (effect) assessment on an active substance or a substance of concern present in a biocidal product.
27.
For repeated dose toxicity and reproductive toxicity the dose-response relationship shall be assessed for each active substance or substance of concern and, where possible, a NOAEL identified. If it is not possible to identify a NOAEL, the lowest-observed-adverse-effect level (LOAEL) shall be identified. Where appropriate, other dose-effect descriptors may be used as reference values.
28.
For acute toxicity, corrosivity and irritation, it is not usually possible to derive a NOAEL or LOAEL on the basis of tests conducted in accordance with the requirements of this Regulation. For acute toxicity, the LD50 (median lethal dose) or LC50 (median lethal concentration) value or another appropriate dose-effect descriptor shall be derived. For the other effects it shall be sufficient to determine whether the active substance or substance of concern has an inherent capacity to cause such effects during use of the biocidal product.
29.
For mutagenicity and carcinogenicity, a non-threshold assessment should be carried out if the active substance or substance of concern is genotoxic and carcinogenic. If the active substance or a substance of concern is not genotoxic a threshold assessment shall be carried out.
30.
With respect to skin sensitisation and respiratory sensitisation, in so far as there is no consensus on the possibility of identifying a dose/concentration below which adverse effects are unlikely to occur, particularly in a subject already sensitised to a given substance, it shall be sufficient to evaluate whether the active substance or substance of concern has an inherent capacity to cause such effects as a result of the use of the biocidal product.
31.
When carrying out the risk assessment special consideration shall be given to toxicity data derived from observations of human exposure where such data are available, e.g. information gained from manufacture, from poison centres or epidemiology surveys.
32.
An exposure assessment shall be carried out for each of the human populations (professional users, non-professional users and humans exposed directly or indirectly via the environment), for which exposure to a biocidal product occurs or can reasonably be foreseen, with particular attention paid to the pathways of exposure relevant for vulnerable groups. The objective of the assessment shall be to make a quantitative or qualitative estimate of the dose/concentration of each active substance or substance of concern, including relevant metabolites and degradation products to which a population is, or may be exposed during use of the biocidal product and articles treated with that product.
33.The exposure assessment shall be based on the information in the technical dossier provided in conformity with Articles 6 and 21 and on any other available and relevant information. Particular account shall be taken, as appropriate, of:
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.
34.When conducting the exposure assessment, special consideration shall be given to adequately measured, representative exposure data where such data are available. Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied.
These models shall:
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.
Relevant monitoring data from substances with analogous use and exposure patterns or analogous properties shall also be considered.
35.Where, for any of the effects set out in point 23 a reference value has been identified, the risk characterisation shall entail comparison of the reference value with the evaluation of the dose/concentration to which the population will be exposed. Where a reference value cannot be established a qualitative approach shall be used.
Assessment factors account for the extrapolation from animal toxicity to the exposed human population. The setting of an overall assessment factor considers the degree of uncertainty in inter-species and intra-species extrapolation. In the absence of suitable chemical-specific data, a default assessment factor of 100 is applied to the relevant reference value. Additional elements can also be considered for assessment factors, including toxicokinetics and toxicodynamics, the nature and severity of the effect, human (sub-)populations, exposure deviations between study results and human exposure with regard to frequency and duration, study duration extrapolation (e.g. sub-chronic to chronic), dose-response relationship and the overall quality of the toxicity data package.
Effects on animal health
36.
Using the same relevant principles as described in the section dealing with effects on humans, the F34competent authority shall consider the risks posed to animals from the biocidal product.
Effects on the environment
37.
The risk assessment shall take account of any adverse effects arising in any of the three environmental compartments — air, soil and water (including sediment) — and of the biota, following the use of the biocidal product.
38.
The hazard identification shall address the properties and potential adverse effects of the active substance and any substances of concern present in the biocidal product.
39.
A dose (concentration) — response (effect) assessment shall be carried out in order to predict the concentration below which adverse effects in the environmental compartment of concern are not expected to occur. This shall be carried out for the active substance and for any substance of concern present in the biocidal product. This concentration is known as PNEC. However, in some cases, it may not be possible to establish a PNEC and a qualitative estimation of the dose (concentration) — response (effect) then has to be made.
40.
The PNEC shall be determined from the data on effects on organisms and ecotoxicity studies submitted in accordance with requirements of Articles 6 and 20. It shall be calculated by applying an assessment factor to the reference values resulting from tests on organisms, e.g. LD50 (median lethal dose), LC50 (median lethal concentration), EC50 (median effective concentration), IC50 (concentration causing 50 % inhibition of a given parameter, e.g. growth), NOEL(C) (no-observed-effect level (concentration)), or LOEL(C) (lowest-observed-effect level (concentration)). Where appropriate, other dose-effect descriptors may be used as reference values.
41.
An assessment factor is an expression of the degree of uncertainty in extrapolation from test data on a limited number of species to the real environment. Therefore, in general, the more extensive the data and the longer the duration of the tests, the smaller the degree of uncertainty and the size of the assessment factor.
42.
For each environmental compartment, an exposure assessment shall be carried out in order to predict the likely concentration of each active substance or substance of concern present in the biocidal product. This concentration is known as the predicted environmental concentration (PEC). However, in some cases it may not be possible to establish a PEC and a qualitative estimate of exposure then has to be made.
43.
A PEC, or where necessary a qualitative estimate of exposure, need only be determined for the environmental compartments to which emissions, discharges, disposal or distributions (including any relevant contribution from articles treated with biocidal products) are known or are reasonably foreseeable.
44.The PEC, or the qualitative estimation of exposure, shall be determined taking account of, in particular and where appropriate:
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.
45.
When conducting the exposure assessment, special consideration shall be given to adequately measured, representative exposure data where such data are available. Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied. The characteristics of these models shall be as listed in point 34. Where appropriate, on a case-by-case basis, relevant monitoring data from substances with analogous use and exposure patterns or analogous properties should also be considered.
46.
For any given environmental compartment, the risk characterisation shall, as far as possible, entail comparison of the PEC with the PNEC so that a PEC/PNEC ratio may be derived.
47.
If it has not been possible to derive a PEC/PNEC ratio, the risk characterisation shall entail a qualitative evaluation of the likelihood that an effect is occurring under the current conditions of exposure or will occur under the expected conditions of exposure.
48.
The F35competent authority shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) if it contains any substance of concern or relevant metabolites or breakdown or reaction products fulfilling the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006, or if it has endocrine-disrupting properties unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
Effects on target organisms
49.
An assessment shall be made to demonstrate that the biocidal product does not cause unnecessary suffering in its effect on target vertebrates. This shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates; where the intended effect is to kill the target vertebrate, the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated.
50.
The F36competent authority shall, where relevant, evaluate the possibility of the development by the target organism of resistance or cross-resistance to an active substance in the biocidal product.
Efficacy
51.
Data submitted by the applicant shall be sufficient to substantiate the efficacy claims for the product. Data submitted by the applicant or held by the F37competent authority must be able to demonstrate the efficacy of the biocidal product against the target organism when used normally in accordance with the conditions of authorisation.
52.Testing should be carried out according to F39Great Britain guidelines where these are available and applicable. Where appropriate, other methods from the list below can be used. If relevant acceptable field data exist, these can be used.
ISO, CEN or other international standard method
national standard method
industry standard method (if accepted by the F38competent authority)
individual producer standard method (if accepted by the F38competent authority)
data from the actual development of the biocidal product (if accepted by the F38competent authority).
Summary
53.
In each of the areas where risk assessments have been carried out, the F40competent authority shall combine the results for the active substance together with the results for any substance of concern to produce an overall assessment for the biocidal product itself. This shall also take account of any cumulative or synergistic effects.
54.
For biocidal product containing more than one active substance, any adverse effects shall also be considered together to produce an overall assessment for the biocidal product itself.
CONCLUSIONS
General principles
55.
The purpose of the evaluation is to establish whether or not the product complies with the criteria set down in point (b) of Article 19(1). The F41competent authority shall reach its conclusion as a result of the integration of the risks arising from each active substance together with the risks from each substance of concern present in the biocidal product, based on the assessment carried out in accordance with points 13 to 54 of this Annex.
56.
In establishing compliance with the criteria set out in point (b) of Article 19(1), the F42competent authority shall arrive at one of the following conclusions for each product-type and each area of use of the biocidal product for which application has been made:
- (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.
57.
The F43competent authority shall, when seeking to establish whether a biocidal product complies with the criteria in point (b) of Article 19(1), take into account uncertainty arising from the variability in the data used in the evaluation process.
58.
If the conclusion arrived at by the F44competent authority is that additional information or data are required, then the F44competent authority shall justify the need for any such information or data. This additional information or data shall be the minimum necessary to carry out a further appropriate risk assessment.
Effects on human and animal health
Effects on human health
59.
The F45competent authority shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the environment. In reaching these conclusions, particular attention shall be paid to vulnerable groups among the different populations.
60.
The F46competent authority shall examine the relationship between exposure and effect. A number of factors need to be considered when examining this relationship. One of the most important factors is the nature of the adverse effect of the substance under consideration. These effects include acute toxicity, irritancy, corrosivity, sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity, neurotoxicity, immunotoxicity, reproductive toxicity, disruption of the endocrine system together with physico-chemical properties, and any other adverse properties of the active substance or substance of concern, or of their relevant metabolites or degradation products.
61.
Typically, the margin of exposure (MOEref) — the ratio between the dose descriptor and the exposure concentration — is in the region of 100, but a MOEref that is higher or lower than this may also be appropriate depending on, among other things, the nature of the critical effects and the sensitivity of the population.
62.
The F47competent authority shall, where appropriate, conclude that criterion (iii) under point (b) of Article 19(1) can only be complied with by application of prevention and protection measures including the design of work processes, engineering controls, use of adequate equipment and materials, application of collective protection measures and, where exposure cannot be prevented by other means, application of individual protection measures including the wearing of personal protective equipment such as respirators, breathing-masks, overalls, gloves and goggles, in order to reduce exposure for professional operators.
63.
If, for non-professional users, the wearing of personal protective equipment would be the only possible method for reducing exposure to an acceptable level for this population, the product shall not normally be considered as complying with criterion (iii) under point (b) of Article 19(1) for this population.
Effects on animal health
64.
Using the same relevant criteria as described in the section dealing with effects on human health, the F48competent authority shall consider whether criterion (iii) under point (b) of Article 19(1) is complied with for animal health.
Effects on the environment
65.The basic tool used in the decision-making is the PEC/PNEC ratio or, if this is not available, a qualitative estimation. Due consideration shall be given to the accuracy of this ratio due to variability in the data used both in measurements of concentration and of estimation.
In the determination of the PEC, the most appropriate model should be used taking into account the environmental fate and behaviour of the biocidal product.
66.
For any given environmental compartment, if the PEC/PNEC ratio is equal to or less than 1, the risk characterisation shall be that no further information and/or testing is necessary. If the PEC/PNEC ratio is greater than 1, the F49competent authority shall judge, on the basis of the size of that ratio and on other relevant factors, whether further information and/or testing is required to clarify the concern or appropriate risk reduction measures are necessary, or whether the biocidal product cannot comply with criterion (iv) under point (b) of Article 19(1).
Water
67.
The F50competent authority shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in water (or its sediments) has an unacceptable impact on non-target organisms in the aquatic, marine or estuarine environment, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect. In particular, the F50competent authority shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1), where under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in water (or its sediments), would undermine the achievement of compliance with the standards laid down in:
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 policy70,
Directive 2008/105/EC, or
international agreements on the protection of river systems or marine waters from pollution.
68.
The F51competent authority shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in groundwater, exceeds the lower of the following concentrations:
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,
unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.
69.
The F52competent authority shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where the foreseeable concentration of the active substance or a substance of concern, or of relevant metabolites, breakdown or reaction products to be expected in surface water or its sediments after use of the biocidal product under the proposed conditions of use:
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,
unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded.
70.
The proposed instructions for use of the biocidal product, including procedures for cleaning application equipment, must be such that, if followed, they minimise the likelihood of accidental contamination of water or its sediments.
Soil
71.
The F53competent authority shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in soil, has an unacceptable impact on non-target species, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
Air
72.
The F54competent authority shall conclude that the biocidal product does not comply with criterion (iv) of point (b) of Article 19(1) where there is a reasonably foreseeable possibility of unacceptable effect on the air compartment, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
Non-target organisms
73.
The F55competent authority shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where there is a reasonably foreseeable possibility of non-target organisms being exposed to the biocidal product, if for any active substance or substance of concern:
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.
74.
The F56competent authority shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where there is a reasonably foreseeable possibility of micro-organisms in sewage treatment plants being exposed to the biocidal product, if for any active substance, substance of concern, relevant metabolite, breakdown or reaction product the PEC/PNEC ratio is above 1, unless it is clearly established in the risk assessment that under field conditions no unacceptable impact, either directly or indirectly, occurs on the viability of such micro-organisms.
Effects on target organisms
75.
Where the development of resistance or cross-resistance to the active substance in the biocidal product is likely, the F57competent authority shall consider actions to minimise the consequences of this resistance. This may involve modification of the conditions under which an authorisation is given. However, where the development of resistance or cross-resistance cannot be reduced sufficiently, the F58competent authority shall conclude that the biocidal product does not satisfy criterion (ii) under point (b) of Article 19(1).
76.A biocidal product intended to control vertebrates shall not normally be regarded as satisfying criterion (ii) under point (b) of Article 19(1) unless:
death is synchronous with the extinction of consciousness, or
death occurs immediately, or
vital functions are reduced gradually without signs of obvious suffering.
For repellent products, the intended effect shall be obtained without unnecessary suffering and pain for the target vertebrate.
Efficacy
77.
The level, consistency and duration of protection, control or other intended effects must, as a minimum, be similar to those resulting from suitable reference products, where such products exist, or to other means of control. Where no reference products exist, the biocidal product must give a defined level of protection or control in the areas of proposed use. Conclusions as to the performance of the biocidal product must be valid for all areas of proposed use and for all areas in F59Great Britain, except where the biocidal product is intended for use in specific circumstances. The F60competent authority shall evaluate dose-response data generated in appropriate trials (which must include an untreated control) involving dose rates lower than the recommended rate, in order to assess if the recommended dose is the minimum necessary to achieve the desired effect.
Summary
78.
In relation to the criteria set out in points (iii) and (iv) of Article 19(1)(b), the F61competent authority shall combine the conclusions arrived at for the active substance(s) and the substances of concern to produce overall summary conclusions for the biocidal product itself. A summary of the conclusions in relation to the criteria set out in points (i) and (ii) of Article 19(1)(b) shall also be made.
OVERALL INTEGRATION OF CONCLUSIONS
The F62competent authority shall, on the basis of the evaluation carried out in accordance with the principles set down in this Annex, come to a conclusion as to whether or not it is established that the biocidal product complies with the criteria laid down under point (b) of Article 19(1).
ANNEX VII
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 |
Annex 1 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 139; 2020 c. 1, Sch. 5 para. 1(1)