SCCS/1237/09
Scientific Committee on Consumer Safety
SCCS
OPINION ON
Clarification of Annex II, entry 168 of the Cosmetic Directive: Choline salts and their Choline
chloride (INN)
The SCCS adopted this opinion at its 4th plenary meeting
of 13 October 2009
__________________________________________________________________________________ About the Scientific Committee s
Three independent non-food Scientific Committees provide the Commission with the
scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. The Committees also draw the Commission's attention
to the new or emerging problems which may po an actual or potential threat.
They are: the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee
on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and are made up of external experts.
In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Evaluation Agency (EMEA), the European Centre for Dia prevention and Control (ECDC) and the European Chemicals Agency (ECHA).
SCCS
The Committee shall provide opinions on questions concerning all types of health and safety
risks (notably chemical, biological, mechanical and other physical risks) of non-food consumer products (for example: cosmetic products and their ingredients, toys, textiles, clothing, personal care
and houhold products such as detergents, etc.) and rvices (for example: tattooing, artificial sun tanning, etc.).
Scientific Committee members
Jürgen Angerer, Ulrike Bernauer, Claire Chambers, Mohammad Chaudhry, Gila Degen, Gerhard Einbrand, Corrado Galli, Thomas Platzek, Suresh Chandra Rastogi, Vera Rogiers, Christophe Rouslle, Tore Sanner, Kai Savolainen, Jacqueline Van Engelen, Maria Pilar Vinardell, Romary Waring, Ian R. White
Contact
European Commission
Health & Consumers
Directorate C: Public Health and Risk Asssment
Unit C7 - Risk Asssment
Office: B232 B-1049 Brusls
日本留学一年费用是多少钱Sanco-Sc6-Secretariat@ec.europa.eu
© European Commission 2009
(ISSN)
The opinions of the Scientific Committees prent the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The opinions are published by the European Commission in their original language only.
ec.europa.eu/health/ph_risk/risk_en.htm
上家
__________________________________________________________________________________ ACKNOWLEDGMENTS
Prof. J. Angerer
Dr. U. Bernauer
Dr. C. Chambers
Prof. G. Degen
Dr. S.C. Rastogi (rapporteur)
Prof. V. Rogiers
Prof. T. Sanner (chairman)
我想对爸爸妈妈说Dr. J. van Engelen
Prof. R. Waring
Dr. I.R. White
Keywords: SCCS, scientific opinion, choline salts and their esters, directive 76/768/ECC
Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), opinion on the clarification of Annex II, entry 168 of the Cosmetic Directive: Choline salts and their Choline chloride (INN)
__________________________________________________________________________________
TABLE OF CONTENTS
丁桂鱼吃什么食物
ACKNOWLEDGMENTS (3)
1.BACKGROUND (5)
2.TERMS OF REFERENCE (6)
(6)
3.OPINION
4.CONCLUSION (10)
5.MINORITY OPINION (10)
七年级上册英语书仁爱版
6.REFERENCES (10)
__________________________________________________________________________________ 1.BACKGROUND
Annex II - list of substances which must not form part of the composition of cosmetic
products – of Directive 76/768/EEC contains under entry no 168: choline salts and their esters, e.g. choline chloride. This entry has been part of the Cosmetic Directive since its
original adoption in 1976, and for that reason no scientific opinion is available as the basis for this entry.
A related substance, acetylcholine, is also banned from u in cosmetic by entry 2 in Annex II: 2-Acetoxyethyltrimethylammonium hydroxide (acetylcholine) (INN) and its salts.
Need for clarifications of the scope of entry II/168:
The German Authorities have asked the Commission for clarification whether lecithin, which
is an ester of choline, is covered by entry II/168. At the same time they have pointed out that different wordings for this entry exist in different languages versions of the Cosmetics Directive.
In 2008, EFfCI requested advice from the Commission on the scope of entry II/168, as a member company has an interest in using stearic acid choline ester as a cosmetic ingredient. In Annex II of the Cosmetics Directive, no definitions are given for salts and esters. However, for salts and esters in connection with Annex VΙ, prervatives, a t of definitions is t out. They are:
- "Salts" is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines: salts of the anions chloride, bromide,
sulphate, acetate.
- “Esters” is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl
The Commission rvices identified from the Cosmetic Ingredients Information system (CosIng) and the Inventory of ingredients employed in cosmetic products, some substances which could be considered covered by entry II/168:
CAS number Substance INN
856676-23-8 Choline fenofibrate Choline fenofibrate [USAN]
2016-36-6 Choline salicylate Choline salicylate
507-30-2 Choline gluconate Choline gluconate
theophylline; Oxtriphylline [USAN]
theophylline Cholinate
4499-40-5 Cholinate
28319-77-9 Glycerophosphocholine Choline alfoscerate
However, entry II/168 has been interpreted by the responsible Commission rvices not to cover hydrogenated lysophosphatidylcholine, hydrogenated phosphatidylcholine, phosphatidylcholine, polyphosphorylcholine glycol acrylate and lecithin, which are choline derivatives also prent in inventory part of the CosIng databa.
Discrepancy in wording in different language versions:
The following versions of entry II/168 of Directive 76/768/EEC exist:
牙齿胀痛
"Choline salts and their esters, e.g. choline chloride" (EN)
"Ester von Cholin und Methylcholin und ihre Salze" (DE)
"Esters de la choline et de la methylcholine et leur ls" (FR)
__________________________________________________________________________________ The latter versions, which are equivalent also to the wording ud the IT, ES, PT versions, translates into
"Esters of Choline and Methylcholine and their salts".
2.TERMS OF REFERENCE
1.Bad on the chemical structure and/or behaviour of the listed substances, does the SCCS consider that entry II/168 does cover:
1a. Choline fenofibrate
Choline salicylate
日小女孩Choline gluconate泡茶的水温度多少最好
Cholinate theophylline
Glycerophosphocholine
1b. Choline esters of stearic acid, as asked for by EFfCI, and other long alkyl chain carboxylic acids
1c. Hydrogenated lysophosphatidylcholine
Hydrogenated phosphatidylcholin
Phosphatidylcholine
Polyphosphorylcholine glycol acrylate
Lecithin
2. Bad on its chemical structure and/or behaviour, does the SCCS consider it justified
to include methylcholine together with choline in entry II/168, as prently the ca in some language versions?
3.OPINION
3.1. General aspects
In general chemical terms, a salt is a chemical compound compod of two or more ions, often a positively charged metal ion (cation) and a negatively charged non-metallic ion (anion), so that the chemical compound is neutral. Salts may also be compod of a non-metallic cation, for example ammonium (NH4+) ion. Anions can be inorganic, e.g. chloride (Cl−), sulphate (SO42−), or acetate (CH3COO−).
Esters are chemical compounds derived by the chemical reaction of an alcohol or phenol with an acid. Esters can be derivatives of carboxylic acids (e.g. ethyl acetate) or inorganic acid (e.g. dimethyl sulfate).
Annex II of Directive 76/768/EEC does not contain a definition of 'salts' and 'esters'. The definition of salts and esters described in the preamble of Annex VI for prervatives of Directive 76/768/EEC on Cosmetic Products is very restrictive and does not include other salts and esters that could be ud as prervatives in cosmetic products. The scientific rationale for this restrictive definition is not t out in any supporting documentation. The SCCS does not e a scientifically valid reason for the limitation of the definition ud in Annex VI and considers that from the chemical point of view, the term "Choline salts and their esters” should in principle cover all possible salts and esters without exception and should not be limited to tho listed in Annex VI.
