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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)
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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.
[F1Column 1 Information required | Column 2 All data is CDS unless indicated as ADS | Column 3 Specific rules for adaption from Column 1] |
---|---|---|
1. APPLICANT | ||
1.1.Name and address | ||
1.2.Contact person | ||
1.3.Manufacturer and formulator of the biocidal product and the micro-organism(s) (names, addresses, including location of plant(s)) | ||
2. IDENTITY OF THE BIOCIDAL PRODUCTS | ||
2.1.Trade name or proposed trade name | ||
2.2.Manufacturer’s development code and number of the biocidal product, if appropriate | ||
[F22.3
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.] | ||
2.4.Formulation type and nature of the biocidal product | ||
[F32.5.Where the biocidal product contains an active substance that has been manufactured in locations or according to processes or from starting materials other than those of the active substance evaluated for the purpose of approval pursuant to Article 9 of this Regulation, evidence has to be provided that technical equivalence has been established in accordance with Article 54 of this Regulation or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive 98/8/EC] | ||
3. BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT | ||
3.1.Biological properties of the micro-organism in the biocidal product | ||
3.2. Appearance (at 20 °C and 101,3 kPa) | ||
3.2.1.Colour (at 20 °C and 101,3 kPa) | ||
3.2.2.Odour (at 20 °C and 101,3 kPa) | ||
3.3.Acidity, alkalinity and pH value | ||
3.4.Relative density | ||
3.5. Storage stability, stability and shelf-life | ||
3.5.1.Effects of light | ||
3.5.2.Effects of temperature and humidity | ||
3.5.3.Reactivity towards the container | ||
3.5.4.Other factors affecting stability | ||
3.6. Technical characteristics of the biocidal product | ||
3.6.1.Wettability | ||
3.6.2.Suspensibility and suspension stability | ||
3.6.3.Wet sieve analysis and dry sieve test | ||
3.6.4.Emulsifiability, re-emulsifiability, emulsion stability | ||
3.6.5.Particle size distribution content of dust/fines, attrition and friability | ||
3.6.6.Persistent foaming | ||
3.6.7.Flowability/Pourability/Dustability | ||
[F43.6.8
Spraying patterns – aerosols] | ||
[F53.6.9
Other technical characteristics] | ||
3.6.10.F6... | ||
3.6.11.F6... | ||
3.6.12.F6... | ||
3.7. Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered | ||
3.7.1.Physical compatibility | ||
3.7.2.Chemical compatibility | ||
3.7.3.Biological compatibility | ||
3.8.Surface tension | ||
3.9.Viscosity | ||
4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS | ||
[F74.1
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] | ||
F7... | ||
5. METHODS OF DETECTION AND IDENTIFICATION | ||
5.1.Analytical method for determining the concentration of the micro-organism(s) and substances of concern in the biocidal product | ||
5.2.Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor the article treated with it does not come into contact with food-producing animals, food of plant and animal origin or feeding stuffs) | ADS | |
6. EFFECTIVENESS AGAINST TARGET ORGANISM | ||
6.1.Function and mode of control | ||
6.2.Representative pest organism(s) to be controlled and products, organisms or objects to be protected | ||
6.3.Effects on representative target organisms | ||
6.4.Likely concentration at which micro-organism will be used | ||
6.5.Mode of action | ||
6.6.The proposed label claims for the product | ||
6.7.Efficacy data to support these claims, including any available standard protocols, laboratory tests, or field trials used including performance standards, where appropriate and relevant | ||
6.8. Any other known limitations on efficacy including resistance | ||
6.8.1.Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies | ||
6.8.2.Observations on undesirable or unintended side effects | ||
7. INTENDED USES AND EXPOSURE | ||
7.1.Field of use envisaged | ||
7.2.Product-type | ||
7.3.Detailed description of intended use | ||
7.4.User e.g. industrial, trained professional, professional or general public (non-professional) | ||
7.5.Method of application and a description of this method | ||
7.6.Application rate and if appropriate the final concentration of the biocidal product or the micro-organism active substance in a treated article or the system in which the product is to be used (e.g. in the application device or bait) | ||
7.7.Number and timing of applications and duration of protectionAny particular information relating to the geographical location or climatic variations including necessary waiting periods for re-entry or necessary withdrawal period or other precautions to protect human health, animal health and the environment | ||
7.8.Proposed instructions for use | ||
7.9. Exposure data | ||
7.9.1.Information on human exposure associated with the proposed/expected uses and disposal | ||
7.9.2.Information on environmental exposure associated with the proposed/expected uses and disposal | ||
8.TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS | Testing on the product/mixture does not need to be conducted if:
| |
8.1.Skin corrosion or irritation | ||
8.2.Eye irritation | ||
8.3.Skin sensitisation | ||
8.4.Respiratory sensitisation | ADS | |
8.5.Acute toxicity
| ||
8.5.1.Oral | ||
8.5.2.Inhalation | ||
8.5.3.Dermal | ||
8.5.4.Additional acute toxicity studies | ||
8.6.Information on dermal absorption if required | ||
8.7.Available toxicological data relating to:
| Testing on the product/mixture does not need to be conducted if:
| |
8.8.Supplementary studies for combinations of biocidal productsFor biocidal products that are intended to be authorised for use with other biocidal products, the risks to humans, animals and the environment arising from the use of these product combinations shall be assessed. As an alternative to acute toxicity studies, calculations can be used. In some cases, for example where there are no valid data available of the kind set out in column 3, this may require a limited number of acute toxicity studies to be carried using combinations of the products | Testing on the mixture of products does not need to be conducted if:
| |
8.9.Residues in or on treated articles, food and feedingstuffs | ADS | |
9. ECOTOXICOLOGICAL STUDIES | ||
9.1.Information relating to the ecotoxicity of the biocidal product which is sufficient to enable a decision to be made concerning the classification of the product is required
| ||
9.2.Further ecotoxicological studiesFurther studies chosen from among the endpoints referred to in Section 8 of Annex II ‘Micro-organisms’ for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product | ||
9.3.Effects on any other specific non-target organisms (flora and fauna) believed to be at risk | 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 | ADS | |
9.4.1.Supervised trials to assess risks to non-target organisms under field conditions | ||
9.4.2.Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk | ||
9.5.Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated | ADS | |
10. ENVIRONMENTAL FATE AND BEHAVIOUR | ||
10.1.Foreseeable routes of entry into the environment on the basis of the use envisaged | ||
10.2.Further studies on fate and behaviour in the environmentWhere relevant, all the information required in Section 9 of Annex II ‘Micro-organisms’ may be required for the product For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern | ADS | |
[F810.3]
Leaching behaviour or mobility | ADS | |
10.4.If the biocidal product is to be sprayed outside or if potential for large scale formation of dust is given then data on overspray behaviour may be required to assess risks to bees under field conditions | ADS | |
11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT | ||
11.1.Recommended methods and precautions concerning: handling, storage, transport or fire | ||
11.2.Measures in the case of an accident | ||
11.3. Procedures for destruction or decontamination of the biocidal product and its packaging | ||
11.3.1.Controlled incineration | ||
11.3.2.Others | ||
11.4.Packaging and compatibility of the biocidal product with proposed packaging materials | ||
11.5.Procedures for cleaning application equipment where relevant | ||
11.6.Monitoring plan to be used for the active micro-organism and other micro-organism(s) contained in the biocidal product including handling, storage, transport and use | ||
12. CLASSIFICATION, LABELLING AND PACKAGING | ||
Example labels, instructions for use and safety data sheets shall be provided | ||
12.1.Indication on the need for the biocidal product to carry the biohazard sign specified in Annex II to Directive 2000/54/EC | ||
12.2.Precautionary statements including prevention, response, storage and disposal | ||
12.3.Proposals for safety-data sheets should be provided, where appropriate | ||
12.4.Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included | ||
13.SUMMARY AND EVALUATIONThe key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed |
Textual Amendments
F1Words in Annex 3 Title 2 table substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 2 para. 1(6)(a) (with reg. 3)
F2Annex 3 Title 2 table row 2.3 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 2 para. 1(5)(b) (with reg. 3)
F3Inserted by Commission Delegated Regulation (EU) No 837/2013 of 25 June 2013 amending Annex III to Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the information requirements for authorisation of biocidal products (Text with EEA relevance).
F4Annex 3 Title 2 table row 3.6.8 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 2 para. 1(5)(c) (with reg. 3)
F5Annex 3 Title 2 table row 3.6.9 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 2 para. 1(5)(d) (with reg. 3)
F6Annex 3 Title 2 table rows 3.6.10-3.6.12 omitted (6.4.2024) by virtue of The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 2 para. 1(5)(e) (with reg. 3)
F7Annex 3 Title 2 table rows 4.1-4.8.3 substituted for rows 4.1-4.12.3 (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 2 para. 1(5)(f) (with reg. 3)
F8Annex 3 Title 2 table row 10.3 substituted (6.4.2024) by The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 (S.I. 2024/352), reg. 1(2), Sch. 2 para. 1(5)(g) (with reg. 3)
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