Product Authorisation

Workshop on REACH and EU Biocidal Product Legislation in practice(Experiences from EU Industry)INT MARKT 48493Belgrade, Serbia

Raf Bruyndonckx1 June 2012

Further considerations

Outline

• Treated Articles

• Products containing non-EU evaluated AS source

• Technical equivalence

• Free-rider issue

• Frame formulation vs. biocidal product family

• Timelines for inclusion of PT1-5 AS

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Treated articles

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• Definition: "treated article" means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products

• A TA shall not be placed on the market only if it is treated with or incorporates approved AS or in Review Program• Exemption for fumigation leaving no residues

• Transitional measure:• Possibility to submit dossier on new AS until 1 Sep

2016

Treated articles

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• Labelling: Instructions for use where necessary to protect HH/ENV - Upon request by consumer, provide information on biocidal treatment, within 45 days

• Specific labelling is required if:• a claim is made regarding the biocidal properties of

the TA, or

• the conditions associated with the approval of the active substance(s) so require

Treated articles

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Specific labelling:• a statement that the TA incorporates biocidal products;• where substantiated, the biocidal property attributed to

the TA;• the name of all active substances contained in the

biocidal products;• the name of all nanomaterials contained in biocidal

products, followed by the word "nano" in brackets;• any relevant instructions for use

Treated articles

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Products containing non-EU evaluated AS source

BP with non-EU evaluated AS source

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• No (limited) recognition of evaluations performed outside

the scope of the EU biocides legislation

• Under BPD and BPR, responsibility for compliance is with

the person placing on the market

• No system of Only Representative

• Art 95 of BPR: importer of a BP needs to be listed as

source for the AS

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Technical equivalence

Definition (BPR)

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• “Technical equivalence" means similarity, as regards the

chemical composition and hazard profile, of a substance

produced either from a source different to the

reference source, or from the reference source but

following a change to the manufacturing process

and/or manufacturing location, compared to the

substance of the reference source in respect of which the

initial risk assessment was carried out.

Two-tiered approach

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• Tier I

• Evaluation of analytical data

• Method of manufacturing

• Specification of purity

• Identity of impurities

• Tier II

• Available test data - initial screening testing

• Guidance under development

TE assessment

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• BPD: performed by Member State

• AS evaluation – Annex I inclusion

• Product authorisation – new source

• BPR: performed by ECHA

• Procedures and guidance under development

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Free-rider issue

The free-rider issue

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• While defended, any actor can place an AS on the market

during the transitional period

• Transitional period is taking longer than expected

• 2010 –> 2014 -> 2025 -> ???

• Complying companies are put at a disadvantage

The free-rider solution

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• As of 1 Sep 2013, companies placing on the market:

• An AS, or

• a BP containing an AS

• Need to comply with the data requirements

• LoA

• New complete dossier

• From 2015, BP can only contain an AS from a compliant

source

The free-rider solution

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• Discussions regarding implementation ongoing:

• Evaluation of new dossiers

• Re-import of AS from EU source

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Frame formulationvs.

biocidal product family

Definitions

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Frame formulation – BPD

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 lower risk, and which do not decrease the

efficacy.

Definitions

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Biocidal Product Family – BPR

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;

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 shall be the same (exception for a

concentrate for professional use and ready-to-use products obtained through dilution).

Comparison

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Frame formulation Biocidal Product Family

Use Same use and same user type Similar use

Composition Reduction of the active;

Alteration in percentage of non-active substances;

Replacement of pigment, dye or perfume.

Elimination of an active in a multi-active product;Reduction of one or more active substances;Elimination of one or more non-active substances;Variation of one or more non-active substances;Replacement of one or more non-active substances.

Risk and efficacy

Same or lower riskNo decrease in efficacy

No adverse effect on level of riskNo significant reduction in efficacy

Comparison

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Concentration (% w/w )

Components

Active A B C D

100

0

Concentration (% w/w )

Components

Active A B C D

100

0

A

B C

D E F

Frame Formulation Biocidal Product Family

Benefits of BPF to FF

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• One application - one authorisation for whole family

• Mutual recognition of a BPF

• 30 day notification period before placing on the market of

existing products in a family or changing pigment, dye or

perfume

• No limit on the number of products in a BPF

• Broad variation on composition possible across a BPF

Industry survey

Today Future Family vs. individual

UA vs. NA+MR

7939

5423

1157

823

864

1116

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Setting up a BPF

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I. Group products according to active substances

II. Divide active substance groups according to use

III. Determine if a BPF can be formed from these sub-

groups using classification, efficacy and hazard profiles

IV. Check for overlaps between the groups – can two

groups be joined into one?

Risk envelope approach

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The risk envelope approach is a concept that exploits the

idea that within a group of biocidal products and use

patterns or for a product with multiple use patterns (i.e.

product-types), there will be certain use patterns which

represent the worst-case or critical situation in each area of

risk assessment.

The assessment of these worst-case/critical products/uses

will cover all other situations where the use pattern is less

critical or the same.

Preparing for authorisation

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• Decision on representative worst case(s), e.g.:

• High active concentration, or multiple actives

• Worst hazard profile

• Major commercial product

• Broad use spectrum/exposure scenario

• Establish testing programme – minimum to support BPF

• Explore read-across and data-waiving

Further clarifications

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• Transitional arrangements: are all members of a BPF

considered as an existing product, even if some are not?

• Mutual recognition: MS can request for derogations – will

they apply to all members of a BPF?

• Very little experience yet with FF – need for clear

guidance regarding BPF

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Timelines for inclusion of PT1-5 Active substances

Overall numbers

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PT Total Annex I inclusion

1 412 83 1*3 534 545 19

* Hydrochloric acid - 1 May 2014

TM or CA discussion

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Nonanoic acid* Perestane

Sodium bromide Gluteraldehyde

Octanoic acid Decanoic acid

Bromoacetic acid Benzoic acid

Cupper sulphate MMPP

DCDMH Sodium hypochlorite

Calcium hypochlorite Active chlorine

Iodine * 1 Oct 2014

Outlook for PT 1-5

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• Very slow progress

• Review programme is not expected to finish before 2025

• Majority will be covered by the new BPR

Raf Bruyndonckx+32 2 676 7366

rbr@cefic.be