來源: 歐盟推新規 化粧品出口遇門檻
歐盟第一部化粧品法規Regulation(EC)No.1223/2009（化粧品GMP）
將于2013年7月11日在27個歐盟成員國(以及挪威、冰島和列支敦士登)中作為國家法律正式實施
新法規列出了對于產品穩定性和包裝材料的要求
包括為新的化粧品產品安全報告收集補充資料，以及對GMP體係的審核/升級等
完成這些工作至少要耗時3~6個月
化粧品出口企業須抓緊時間，及時取得歐盟化粧品GMP認證
“與皮膚接觸的化粧品都要通過這個認證，否則就進不去樂購、沃爾瑪、家樂福等超市
歐盟新指令將全面替代舊的化粧品指令，且其所涉及的產品影響范圍廣
包括乳霜、乳液、化粧水、凝膠及潤膚劑、肥皂、防臭劑、香水以及口腔護理等
不符合規定的化粧品將不得在歐盟成員國銷售
挖~這個改變影響很大, 有做外銷的化妝品公司要趕快反應囉~
連結：Regulation (EC) No 1223/2009
原汁原味，毫無修改：
Cosmetic products (from 2013)
From 11 July 2013, this Regulation will replace the “Cosmetics Directive” which until now ensured that products circulate freely whilst guaranteeing a high level of protection for consumers. The provisions of the Regulation aim at ensuring that consumers’ health is protected and that they are well informed by monitoring the composition and labelling of products. The Regulation also provides for the assessment of product safety and the prohibition of animal testing.
ACT
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Text with EEA relevance).
SUMMARY
Cosmetic products are substances * or mixtures of substances intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, etc.) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
Free movement of these products in the internal market is permitted if they comply with this Regulation.
Market surveillance
A responsible person established in the Community shall be designated for each product placed on the market. This person shall ensure compliance of the products with the rules set out in the Regulation. In particular, they shall ensure compliance with requirements relating to human health, safety and consumer information. They shall maintain a product information file accessible to the public authorities.
In order to ensure product traceability, responsible persons shall identify the distributors to whom they supply the cosmetic product: for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor. The same applies to all other persons involved in the supply chain.
In case of product non-compliance, the responsible person shall take measures to render it compliant, withdraw it from the market or recall it to the manufacturing company in all Member States where the product is available. Where the responsible person does not take all appropriate measures, the competent national authorities may take the necessary corrective measures.
If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority shall take all necessary provisional measures to withdraw, recall or restrict the availability of the product on the market.
Limitations for certain substances
The Annexes of this Regulation give a list of prohibited substances (Annex II) or restricted substances (Annex III) with respect to use in cosmetic products. Certain colorants (other than those in Annex IV), preservatives (other than those in Annex V) and UV-filters (other than those in Annex VI) are also prohibited.
The Regulation prohibits the use of substances recognised as carcinogenic, mutagenic or toxic for reproduction (classified as CMR), apart from in exceptional cases. It provides for a high level of protection of human health where nanomaterials are used in cosmetic products.
Consumer information
Product labelling contributes to consumer protection. Containers or packaging must bear written information in indelible, easily legible and visible lettering. This information concerns:
the name or registered name and the address of the responsible person;
the country of origin for imported products;
the weight or volume of the content at the time of packaging;
a use-by date for products kept in appropriate conditions;
precautions for use, including for cosmetics for professional use;
the batch number of manufacture or the reference for identifying the cosmetic product;
the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing.
The language of the information shall be determined by the Member State where the product is made available to the end user.
Animal testing
Animal testing must be replaced by alternative methods. The Regulation prohibits the performance of animal testing in the European Union for:
finished products,
ingredients or combinations of ingredients.
The Regulation also prohibits the placing on the European Union market of:
products where the final formulation has been the subject of animal testing;
products containing ingredients or combinations of ingredients which have been the subject of animal testing.
A derogation from the ban relating to placing products on the market shall be granted until 11 March 2013 in order to test repeated-dose toxicity, the effects of certain substances on reproduction and to study toxicokinetics *.
In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.
Committee procedure
The Commission shall be assisted by the Standing Committee on Cosmetic Products.
Context
This Regulation recasts Directive 76/768/EEC due to the many amendments made to it and the new amendments that were required.
The new Regulation shall apply in 2013. However, some of its provisions will apply from 1 December 2010: they concern substances which are carcinogenic, mutagenic or toxic for reproduction (classified as CMR).