96 JOURNAL OF COSMETIC SCIENCE
REACH ...ONE COMPANV1S I/JEW AND RESPONSE
TO THIS IMPORTANT INDUSTRY CHALLENGE
Peter Megaw
Croda International Pie.
REACH is corning. It is corning fast, and when it arrives it will be here to stay with us for a long time.
As I write this pre-print the latest available official text of the legislation is the "Common position adopted
by the Council with a view to the adoption of
a Regulation of the European Parliament and of the Council concerning
the Registration, Evaluation, Authorization and Restriction of Chemicals
(REACH) ........."of June 2006. However it is expected that this text already indicates the major
elements of what will within a few months be adopted as European Union Legislation.
It is already evident that the legislation represents a revolution in chemicals control in Europe, and one
whose requirements the legislation itself foresees will have to be implemented largely by chemicals
manufacturers, suppliers and down-stream users, rather than by the regulatory authorities themselves.
I am not going to try to review the whole of the legislation here. Instead I am going to consider how
companies should be preparing by reference to specific selected elements of the legislation. What they will
need to do, what they can do in advance, what it is unreasonable to expect can be done now, what we will
be expected to have done already. I am going to consider some of the issues that are of special interest to
cosmetic ingredient suppliers and cosmetic ingredient users. I will give examples of actions that Croda, as a
company supplying significant quantities of ingredients for cosmetics and personal care, has taken and is
taking.
Pre-registration.
The article on "entry into force and application" (the last Article -140 -in the text of June 06) indicates
that the Regulation in general will come into force 20 days after publication in its final form and Title II
(Registration of substances) will come into force 12 months later. If we do nothing in advance, this means
that we would need a full notification dossier for all substances we put on the European market 12 months
after corning into force (this could be as early as spring 2008 therefore!). To avoid this, and take advantage
of appropriate 3, 6 or 11 year "extensions" of time allowed for "phase-in" substances (i.e. those already in
the European Inventory of Existing Chemical Substances [EINECS] or of similar status) companies must
pre-register their interest in a substance.
Who needs to pre-register?
Essentially anyone manufacturing a substance in Europe or importing the substance into the European
market needs to pre-register. This includes importers of materials as components of preparations. Note that
in this context most cosmetics are "preparations" as defined in the REACH regulation and not "articles".
What is needed to pre-register?
The requirements are given in Article 28 of the June 2006 text.
These include:
(a) the name of the substance as specified in section 2 of Annex VI, including its EINECS and CAS
number or, if not available, any other identity codes ,..
(b) his name and address and the name of the contact person and, where appropriate, the name and
address of the person representing him ...
(c) ...the envisaged deadline for the registration/tonnage band
...2. The information referred to in paragraph 1 shall be submitted within a time period starting on [...12
months after entry into force] and ending on[... 18 months after entry into force ...]*.

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?
97
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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