REACH and the cosmetics industry - Alan Ritchie Senior Consultant Caleb Management Services Ltd 18 June 2008
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REACH and the cosmetics
industry
Alan Ritchie
Senior Consultant
Caleb Management Services Ltd
18 June 2008
1Summary of today’s
presentation
• Pre-registration, SIEFs and consortia
• Downstream users
• Testing
• Commercial consequences of REACH
• Relevant Caleb Experience
2Pre-registration, SIEFs and
consortia
• What is involved in pre-registration:
– does the substance have to be registered
(Annex IV and V exemptions, “naturals”);
• Annex IV - Exemptions from the obligation to
register in accordance with article 2(7)(a)
– List of specific substances
– List not very logical
» e.g. lauric (C12 linear fatty acid), and palmitic (C16
linear fatty acid) listed; myristic (C14 linear fatty
acid) is not…
» Commission reviewing list
» Updated list not ready for start of pre-registration –
may not be published before pre-registration ends
• Conclusion: if not listed: PRE-REGISTER! 3Pre-registration, SIEFs and
consortia
– Annex V - Exemptions from the obligation to
register in accordance with article 2(7)(b)
• Lists 9 categories: critical for cosmetics industry:
8. Substances occurring in nature other than those listed under
paragraph 7, if they are not chemically modified, unless they
meet the criteria for classification as dangerous according to
Directive 67/548/EEC.
• Natural not necessarily exempt:
– Chemical processing (e.g. solvent extraction –
INCLUDES e.g. SCFE)
– Classified as dangerous
4Pre-registration, SIEFs and
consortia
• Difficulties:
– Ambiguous CAS numbers;
• Substance characterised by different CAS
numbers in different jurisdictions;
• No CAS registry entry
– Does it qualify as “phase-in” or not;
• Must be on EINECS or non-listed NLP
– But who owns the NLP if not listed?
5Pre-registration, SIEFs and
consortia
– Non EINECS listed products
• Notified?
• If not on EINECS and not notified, must be
registered, but no benefits to pre-registration
• Maybe no SIEF required
– Reaction mixtures/substances of
unknown/variable composition;
1. Substance …chemical element and its compounds in the
natural state or obtained by any manufacturing process,
including any additive necessary to preserve its stability and
any impurity deriving from the process used, but excluding
any solvent which may be separated without affecting the
stability of the substance or changing its composition;
6Pre-registration, SIEFs and
consortia
– Why do some substances not have CAS
numbers; what about notified substances?
• Notified substances deemed to be registered, but…
such substances in a cosmetic formulation
excluded from notified volumes under 67/548, but
included under REACH
7Pre-registration, SIEFs and
consortia
• How does a SIEF form;
– How do I know who the other players are?
• SIEFs/consortia:
– What’s the difference?
• SIEFs are bound by REACH rules, but
competition law takes precedence;
• Only EU legal entities (including ORs) can join
SIEFs
• Consortia are legal entities
• Can commission testing and spend $
• Anyone can join – EU or not 8
Wh f ti ?Downstream users
• What is a downstream user?
• Definition 13 … any natural or legal person
established within the Community, other than the
manufacturer or the importer, who uses a substance,
either on its own or in a preparation, in the course of
his industrial or professional activities.
• When does a DU become a
manufacturer/importer?
– Changes where substance is bought
– Meaning of “importer” under REACH
• Made overseas and brought into EU
9Downstream users
• What are a DU’s responsibilities under
REACH?
Whereas 58:
“In order to have a chain of responsibilities, downstream users should be
responsible for assessing the risks arising from their uses of substances if
those uses are not covered by a safety data sheet received from their
suppliers, unless the downstream user concerned takes more protective
measures than those recommended by his supplier or unless his supplier was
not required to assess those risks or provide him with information on
those risks. For the same reason, downstream users should manage the risks
arising from their uses of substances…”
10Downstream users
• What are a DU’s responsibilities under
REACH?
– Reporting up the supply chain
– Confidentiality issues
– Exposure information
– Registered uses
11Testing • Costs/tonnage band (worst case scenario 1) (per substance): 1-10 10-100 100-1000 >1000 tonnes tonnes tonnes tonnes $80,357 $347,359 $1,754,326 $4,217,079 €45,400 €196,100 €990,300 €2,380,500 1 Assuming no data available at all, no waivers exemptions or derogations, no read across/surrogate data • Therefore: conduct an impact assessment! 12
Testing
• Likely test gaps:
– Likely to vary a lot from one substance and
one company to another
– Probable environmental gaps
13Testing
• How can certain tests be avoided?
– Polymers (but not NLPs)
– Not relevant/appropriate/not technically possible (e.g.
granulometry for fluids)
– Not necessary due to exposure patterns (e.g. inhalation
toxicity for substances only used in dermal preparations)
– Read across/surrogate data
– Grouping
– QSARs
– Available data for another endpoint makes test
unnecessary
– Substance of low inherent stability (many tests can be
waived if a substance is biodegradable) 14Testing
• What about the Cosmetics Directive
animal testing ban?
– Are tests conducted for REACH applicable
– French decision
– Positive listing (preservatives, UV
absorbers, pigments)
– Other jurisdictions
– Other applications
?
15Commercial consequences of
REACH
• Registration costs (Standard)
Tonnage SMEs in
category Individual Joint SMEs a SIEF
1 – 10 t € 1,600 € 800 € 900 € 500
>10 t – 100 t € 4,360 € 2,180 € 2,440 € 1,370
>100 t – 1000 t € 11,500 € 5,925 € 6,630 € 3,715
>1000 t € 31,000 € 16,080 € 18,000 € 10,080
16Commercial consequences of
REACH
• Registration costs (reduced)
Medium Medium Small Small Micro Micro
Enterprise Enterprise Enterprise Enterprise Enterprise Enterprise
(Individual (Joint (Individual (Joint (Individual (Joint
Submission) Submission) Submission) Submission) Submission) Submission)
1-10 t € 1,120 € 840 € 640 € 480 € 160 € 120
10-
100 t € 3,010 € 2,258 € 1,720 € 1,290 € 430 € 323
100 -
1000 t € 8,050 € 6,038 € 4,600 € 3,450 € 1,150 € 863
>1000 t € 21,700 € 16,275 € 12,400 € 9,300 € 3,100 € 2,325
17Commercial consequences of
REACH - Testing (recap)
• Costs/tonnage band (worst case scenario 1
(per substance):
1-10 10-100 100-1000 >1000
tonnes tonnes tonnes tonnes
$80,357 $347,359 $1,754,326 $4,217,079
€45,400 €196,100 €990,300 €2,380,500
1 Assuming no data available at all, no waivers
exemptions or derogations, no read
across/surrogate data
18What are the big issues for the
cosmetics industry?
• Costs of data generation
• Substances legally imported into EU as
part of a cosmetics formulation but
which do not qualify for phase-in status
(e.g. not on EINECS)
• The animal testing conundrum
19What are the big issues for the
cosmetics industry?
• Product availability issues:
– Rationalisation;
– Reformulation;
– Preservative availability due to
• REACH
• BPD
• Other issues (endocrine effects, formaldehyde,
sensitisation, costs of support with Cosmetics
Annex listing required testing e.g. branch chain
parabens)
20Introduction to Caleb
Management Services (1)
• Consultancy established in 1994 by Paul
Ashford (MD) - have worked in chemical
risk assessment since then
• Extensive experience in managing Task
Forces and consortia for OECD SIDS and
US HPV Challenge Programmes
• Five key personnel with chemical
expertise and proven REACH experience
21Introduction to Caleb
Management Services (2)
• Approved REACHReady Service Provider
• Contracted advisory roles with chemical
trade associations (including complex
product portfolios)
• REACH consortia are already emerging
from these relationships
• Contracted as Only Representative to non-
EU manufacturers
22Introduction to Caleb
Management Services (3)
• Services offered:
– REACH Training
– REACH Impact Assessments
– Consortium formation and management
– Third Party representation
– Only representative
– Pre-registration and registration support
– EU regulatory advice
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