Tuesday, August 21, 2012News

Which safety assessment for natural substances?

L'évaluation de la sécurité des substances naturelles

As part of the obligations set out in Annex I to Cosmetics Regulation 1223/2009, safety assessment concerns all substances, including natural substances. But the latter have very particular characteristics and specificities, which make this aspect of the case sometimes quite difficult to manage. Laurence Mulon, from Mulon Conseil, gave an update on the obligations in this area at the 27th session of the Matinales de la Cosmétique.

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Laurence Mulon is a consultant specializing in natural substances. She works every day on their characterization and toxicological profile: she was therefore the specialist of choice to review this subject, and focused her intervention on legal obligations and minimum levels of requirements to ensure safety in this area.

What is a natural substance?

A few definitions opened the discussion.

The Cosmetic Regulation 1223/2009
It defines a natural substance as a chemical element and its compounds existing in the natural state or obtained through a manufacturing process, including:
• Any additive necessary to preserve its stability
• And any impurity resulting from the process implemented
but excluding
• Any solvent that can be separated without affecting the stability of the substance or changing its composition

The REACH Regulation
It refers, more than natural substances, to substances present in nature, such as natural substances:
• As such, untreated or treated only by natural mechanical or gravitational means, by dissolution in water, flotation, extraction by water, steam distillation or heating only to remove water
• Or which are extracted from the air by any means
Excluding chemical treatments, Laurence Mulon pointed out.

ISO 9235:1997
This standard, entitled Natural aromatic raw materials - Vocabulary …

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