2006 ANNUAL SCIENTIFIC MEETING
3. Registrants who do not submit the information required under paragraph 1 shall not be able to rely on
Article 23"
.[Article 23 gives 3, 6, 11 year transitions for full registration].
What should we be doing now?
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It is clear from the above that we need to know which substance we manufacture in, use in, import into the
European Union -and even those we might wish to manufacture in, use in or import into the European
Union. We need to know the identity of these substances sufficiently well to assign a specific CAS registry
number, and we need to know for how much of these materials we have each of the roles of manufacturer,
first importer of the substance or first importer of the preparation(s) containing each substance. If we think
we are not the importer we need to know who is -are they pre-notifying? Do they know their volumes?
Have they identified their substances?
Compared to much of the 1000 pages or so of the full REACH regulation with its annexes this is relatively
easy data to gather and relatively cheap but it matters -NOW! -because there will only be a 6 month
window to pre-register, the 6 month window opens 12 months after entry into force.
Are cosmetics (and their ingredients) not exempt?
According to Article (2) paragraph 6 on "Application" the provisions of Title IV (information in the supply
chain- safety data sheets) shall not apply to:
"(b) cosmetic products as defined in Council Directive 76/768/EECI "
Also according to Article 14 "Chemical safety report and duty to apply
and recommend risk reduction measures":
"5. The chemical safety report need not include consideration of the risks to human health from
the following end uses:
.........b) in cosmetic products within the scope of Directive 76/768/EEC."
These are the only exclusions -and they apply only to finished cosmetic products, and only in the context
of human health.
Are "cosmetic articles" not exempt?
Chapter 2, Article 3 gives definitions including.
"2) Preparation: means a mixture or solution composed of two or more substances
3) Article: means an object which during production is given a special shape, surface or design which
determines its function to a greater degree than does its chemical composition "
Clearly according to these definitions the vast majority of finished cosmetics will be "preparations" and not
"articles". The components of such preparations will need to be pre-registered and registered in the same
way as any other substances. (Are polymers exempt? -yes as long as their monomers and other starting
substrates are registered- and the polymer composition conforms to that given in the regulation).
So what should I be doing as a cosmetics manufacturer in the USA? What should I not be trying to
do? (What is Croda doing as an EU-based manufacturer and importer of ingredients?)
Advice on this has been surprisingly consistent from EU-based industry associations. Since 2004 CEFIC
(the European chemical Industry Council) has been advising companies to:
"(l) Produce your own inventory of chemical substances that will be
subject to REACH
(2) Establish which legal entity of your Group of companies is involved as manufacturer or importer
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98 JOURNAL OF COSMETIC SCIENCE
(4) Establish a list of your customers and what their uses are also establish whether the substance is being
sold to downstream users and/or consumers via distributors .........
(5) Establish whether there are for your substances:
Hazard property information, i.e. any available studies according to Annexes V through VIII of REACH
[old numbering] or other types of hazard information, e.g. human data or QSARs, of your own or others,
including vertebrate animal tests Classification &Labeling information Safety data sheet (and, if necessary,
bring them in line with existing regulation).
Exposure information across the supply chain i.e. exposures of your own workforce and exposures at your
customers' workplaces and eventually in final uses."
This has much in common with CO LIP A (The European Cosmetic toiletry and perfumery Association)
advice from summer 2006, which for cosmetic manufacturers notably adds the further advice" ...establish
your company's REACH team ...prioritize your ingredients ...proactively start a dialogue with your
suppliers".
What's Croda done so far, what have you learned already?
We have been tracking the development of REACH since publication of the "White Paper" in February
2001. We had even 2 years ago already prepared volume rankings of our finished product range as sold,
aggregated by CAS registry number, adjusted for activity, allowing for exclusions of polymers and
materials on "Annex IV''. This is a significant undertaking by "normal" standards, but one over which we
had control of input and timing. Preparation of an inventory of our raw material is still on-going. This is a
much more difficult undertaking, for example multiple suppliers of the "same" product turn out to assign
different CAS numbers or even mention none on their MSDS, different suppliers have different status for
the same material -sometimes we are the importer, sometimes our supplier is, sometimes our supplier is
the manufacturer- even for the same substance. Our advice is "if you haven't started your inventory yet,
then start as soon as you can".
In terms of responding to customer enquiries we have prepared a position statement that first confirms that
we are aware of REACH and that we know what the requirements will be. It refers customers to the current
status of the legislation and activities on its implementation. We indicate that we are taking part in industry
association activities in preparation for implementation, including identification of possible consortia
partners. However we also make it clear that it is not possible to give absolute undertakings that a material
will be supported through the REACH process in advance (no association we know of is advising any
company that they should be able to reasonably ask for such an undertaking -but this has not stopped
customers from asking!).
Hang on -you've largely discussed activities before and up to pre-registration -we've not even got
to "R" for Registration yet, what about Evaluation, Authorization?
"Learn to walk before you try to run" the activities described above need to be carried out now! You need a
team to start preparing for pre-registration now. There is a lot of information out there about REACH -so
much guidance, for example in "Reach Implementation Projects" that you might need guidance on the
guidance. The first step is to realize that you need to have a team working on the issue -that team can find
more information, and as long as you pre-register and joint a Substance Information Exchange Forum
(SIEF) as foreseen by the legislation you should find partners with a common interest in most substances
who will be forming consortia to supply shared data and reduce cost.
If you've done all this already- congratulations! You have still a long way to go, but you are ahead of
many.