Biocidal Product Families instead of Frame Formulations The right step forward? Sara Kirkham

Transcription

1 Biocidal Product Families instead of Frame Formulations The right step forward? Sara Kirkham

2 Content What is a Frame Formulation (FF) Comparison of BPF to FF BPF inclusion criteria Practical issues of defining a BPF Examples Conclusions 2

3 Frame Formulation FRAME FORMULATION (98/8/EC) Specifications for a group of biocidal products having the same use and user type. This group of products must contain the same active substances of the same specifications, and their compositions must present only variations from a previously authorised biocidal product which do not affect the level of risk associated with them and their efficacy. In this context, a variation is the allowance of a reduction in the percentage of the active substance and/or an alteration in percentage composition of one or more non-active substances and/or the replacement of one or more pigments, dyes, perfumes by others presenting the same or a lower risk, and which do not decrease its efficacy. 3

4 Risk Envelope Approach Guidance Document on the Preparation and Submission of Dossiers for Plant Protection Products According to the Risk Envelope Approach SANCO 11244/2011 Rev.5 14 March 2011 as a concept which exploits the idea that in each area of assessment the supported uses of a product can be grouped taking into account certain criteria and the assessment can be targeted at the group rather than individual uses. This can lead to identifying a worst case group for a specific field of assessment which can be assessed as representative for all other groups. 4

5 BPF Criteria Note (36) To facilitate access to the market it should be possible to authorise a group of biocidal products as a biocidal product family. Biocidal products within a biocidal product family should have similar uses and the same active substances. Variations in the composition or the replacement of non-active substances should be specified, but may not adversely affect the level of risk or significantly reduce the efficacy of the products. Definition: biocidal product family means a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products 5

6 BPF Criteria Art 17(3) An authorisation may be granted for a single biocidal product or a biocidal product family. Art 17(6) The authorisation holder shall notify each competent authority that has granted a national authorisation for a biocidal product family of each product within the biocidal product family at least 30 days before placing it on the market, except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations. The notification shall indicate the exact composition, trade name and suffix to the authorisation number. In the case of a Union authorisation, the authorisation holder shall notify the Agency and the Commission. 6

7 BPF Criteria One authorisation covers whole family one fee, one evaluation Mutual recognition of the family 30 day notification period before placing of new products in family on the market. No limit on the number of products in each family Broad variation on composition possible across the family as long as the risk and efficacy are not adversely affected. 7

8 Art 19(6) BPF Criteria In the case of a biocidal product family, a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The classification, hazard and precautionary statements for each product within the biocidal product family shall be the same (with the exception of a biocidal product family comprising a concentrate for professional use and ready-for-use products obtained through dilution of that concentrate). 8

9 BPF Defining Criteria Active substance specification must the same All products must have the same CLP: The classification, hazard and precautionary statements for each product within the biocidal product family shall be the same. The products should have similar uses 9

10 Example 1: AI Specification In-situ generated substance 10

11 Example 1: AI Specification Metal ions 11

12 Example 2:Classification PT 2: Disinfectant liquid 5% H 2 O 2 (CAS No ) 5% anionic surfactant 5% non-ionic surfactant 0.1% Perfume Solvent - water Dose: 5 ml 12

13 Example 2:Classification Trigger spray Ready for use liquid Wipe Dose conc. 5 ml 5 ml 5 ml H2O2 % 5% 5% 0.25% Classification Eye Irrit 2 H319 Eye Irrit 2 H319 Not classified Inclusion in family YES YES NO 13

14 Example 3: Similar Use Product Type Area of use Exposed population Access to PPE Environmental exposure STP or direct release Biocidal Product Family? Bathroom domestic General population 2: Hard surface disinfection Plastic outdoor furniture - domestic General population Hospital Professional Restaurant tables Professional No No Yes Yes Yes Yes Yes Yes STP Direct STP STP NO NO YES YES 14

15 PT 6 Example 3: Similar Use Preservation of manufactured product Preservation of manufactured product Type of product Paint Washing-up liquid Preservation of manufactured product Textile dye Preservation of rodenticides Wax bait Treated article YES YES YES NO Exposed population Exposure routes Environment: STP or direct release Biocidal product Family? Inclusion into product: Industrial Use of treated article: Professional and General Public Inhalation, dermal, incidental mouthing (child) Oral, dermal, inhalation Dermal, incidental mouthing (child) Industrial Professional Dermal STP and Direct STP STP Direct NO NO NO NO 15

16 Positives Summary Cheaper than a Frame formulation or normal authorisation. One evaluation for all the products in the family. 30 day notification period to add a new product Negatives Restrictive criteria Hazard based not risk. Loss of risk envelope approach No guidance on similar use 16

17 Conclusion Consideration of difficulties facing disinfectant and preservative formulators Guidance available in sufficient time for formulators to prepare. Definition of similar use parameters Pragmatism by Authorities on classification Re-introduction of risk envelope approach 17

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