Transcript Frame formulation vs. biocidal product family

Product Authorisation
Further considerations
Workshop on REACH and EU Biocidal
Product Legislation in practice
(Experiences from EU Industry)
INT MARKT 48493
Belgrade, Serbia
Raf Bruyndonckx
1 June 2012
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
2
Treated articles
3
5
Treated articles
• 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
6
Treated articles
• 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
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Treated articles
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
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Products containing non-EU
evaluated AS source
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BP with non-EU evaluated
AS source
• 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
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Definition (BPR)
• “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.
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Two-tiered approach
• 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
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TE assessment
• 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
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The free-rider issue
• 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
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The free-rider solution
• 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
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The free-rider solution
• Discussions regarding implementation ongoing:
• Evaluation of new dossiers
• Re-import of AS from EU source
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Frame formulation
vs.
biocidal product family
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Definitions
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.
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Definitions
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).
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Comparison
Use
Frame formulation
Biocidal Product Family
Same use and same user type
Similar use
Composition Reduction of the active;
Replacement of pigment, dye or
perfume.
Elimination of an active in a multiactive product;
Reduction of one or more active
substances;
Elimination of one or more nonactive substances;
Variation of one or more nonactive substances;
Replacement of one or more nonactive substances.
Same or lower risk
No decrease in efficacy
No adverse effect on level of risk
No significant reduction in efficacy
Alteration in percentage of nonactive substances;
Risk and
efficacy
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Comparison
Concentration
(% w/w)
100
A
B
D
C
E
F
0
Active
A
B
C
D
Components
Frame Formulation
Biocidal Product Family
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Benefits of BPF to FF
• 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
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Industry survey
7939
5423
Today
Future
823
1116
1157
864
Family vs.
individual
UA vs.
NA+MR
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Setting up a BPF
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?
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Risk envelope approach
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.
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Preparing for authorisation
• 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
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Further clarifications
• 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
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Overall numbers
PT
Total
1
2
3
4
5
41
83
53
54
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Annex I
inclusion
1*
* Hydrochloric acid - 1 May 2014
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TM or CA discussion
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
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Outlook for PT 1-5
• Very slow progress
• Review programme is not expected to finish before 2025
• Majority will be covered by the new BPR
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Raf Bruyndonckx
+32 2 676 7366
[email protected]