Biocidal Product Families instead

of Frame Formulations

The right step forward?

Sara Kirkham

Content

• What is a Frame Formulation (FF)

• Comparison of BPF to FF

• BPF inclusion criteria

• Practical issues of defining a BPF

• Examples

• Conclusions

2

Frame Formulation

3

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.

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

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

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

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

BPF Criteria

Art 19(6)

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

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

Example 1: AI Specification

In-situ generated substance

10

Example 1: AI Specification

Metal ions

11

Example 2:Classification

PT 2: Disinfectant liquid

5% H2O2 (CAS No 7722-84-1)

5% anionic surfactant

5% non-ionic surfactant

0.1% Perfume

Solvent - water

Dose: 5 mL

12

Example 2:Classification

13

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

Example 3: Similar Use Product Type 2: Hard surface disinfection

Area of use Bathroom

domestic

Plastic outdoor

furniture -

domestic

Hospital Restaurant

tables

Exposed

population

General

population

General

population

Professional Professional

Access to PPE No No Yes Yes

Environmental

exposure Yes Yes Yes Yes

STP or direct

release STP Direct STP STP

Biocidal

Product

Family?

NO NO YES YES

14

Example 3: Similar Use PT 6 Preservation of

manufactured

product

Preservation of

manufactured

product

Preservation of

manufactured

product

Preservation of

rodenticides

Type of product Paint Washing-up

liquid

Textile dye Wax bait

Treated article YES YES YES NO

Exposed population

Inclusion into product: Industrial Use of treated article: Professional and General Public

Industrial Professional

Exposure routes Inhalation,

dermal,

incidental

mouthing (child)

Oral, dermal,

inhalation

Dermal,

incidental

mouthing (child)

Dermal

Environment:

STP or direct

release

STP and Direct STP STP Direct

Biocidal product

Family? NO NO NO NO

15

Summary

• Positives

– 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

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

www.cehtra.com

sara.kirkham@cehtra.co.uk

CEHTRA UK Ltd 6th Floor, City Gate East, Toll House Hill, Nottingham NG1 5FS UK

18