Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
2.2.3.1 Food or feedingstuffs
When a substance is used in food for humans or feedingstuffs for animals in accordance with
the Food Safety Regulation (EC) No 178/2002, the substance does not have to be registered.
This includes the use of the substance:
as a food additive in foodstuffs within the scope of Council Directive 89/107/ECC;
as a flavouring in foodstuffs within the scope of Council Directive 88/388/ECC and
Commission Decision 1999/217/EC;
as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;
in animal nutrition within the scope of Council Directive 82/471/EEC.
The Food Safety Regulation already requires that food for humans cannot be placed on the
market unless it is safe, i.e. not injurious to human health and fit for human consumption.
Similarly, according to the Food Safety Regulation, feed is not to be placed on the market or
fed to food-producing animals unless it is safe, i.e. not having an adverse effect on human or
animal health and not making the food derived from food-producing animals unsafe for
humans. Moreover, for food additives, food flavourings and their source materials,
feedingstuffs additives and animal nutrition, specific pieces of EU legislation already create a
system for authorisation of substances for those particular uses. Therefore, registration under
REACH would be considered as double regulation.
Accordingly, it is in the interest of manufacturers and importers of substances which may be
put to food or feedingstuffs related uses to be aware if their own legal entity or their clients
actually use the substance in food or feedingstuffs in accordance with the Food Safety
Regulation, since in that case they will not have to register this use at least for the quantities
of the substance which are used in this way.
Substances manufactured in the EU and exported to a third country that satisfy the
requirements of the Food Safety Regulation are also exempted from registration under REACH
to the extent that the substances are used in food or feedingstuffs. Imports of substances for
that use from a third country are also covered by the same exception and do not have to be
registered under REACH.
Note that quantities of the same substance used for other uses than food and feedingstuffs are
not exempted from registration. Only the quantities of the substance used in food and
feedingstuffs are exempted from the registration obligation under REACH.
Example
A manufacturer manufactures 100 tonnes of sulphuric acid in year X. 50 tonnes are used in
foodstuffs in accordance with the Food Safety Regulation, 50 tonnes are used for the
formulation of a non-food mixture. The 50 tonnes used for the formulation of the non-food
mixture will be subject to the registration provisions of the REACH Regulation while the 50
tonnes used in foodstuffs are exempted.
Legal reference: Article 2 (5) (b)
2.2.3.2 Medicinal products
When a substance is used in a medicinal product within the scope of:
either Regulation (EC) No 726/2004 on Community procedures for the authorisation
and supervision of medicinal products for human and veterinary use and establishing a
European Medicines Agency;
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