Customs Union Russia, Belarus and Kazakhstan: placing cosmetics on the market

The Technical Regulation on the safety of cosmetic products TR TC 009/2011Adopted on 23 September 2011 by the Commission of the Customs Union (Decree No. 799). aims at a better harmonisation of requirements applying to cosmetic products in the member countries of the Customs Union - Russia, Belarus and Kazakhstan - with the European rules [1]. Actually, the text that entered into force on the July 1, 2012, still contains a lot of specificities.

As far as labelling is concerned, the Technical Regulation requires several additional constraints when compared to the rules of the European Union. These include:

– The mention of the name and address of the company, registered in the territory of the Customs Union, responsible for the distribution of products,
– The indication of the shade (or the dye) for makeup and hair dye products,
– The indication of fluorine contents by weight, for oral hygiene products,
– The expiry date and the date of manufacture of the product,
– The Eurasian conformity mark.

Regarding technical requirements, Regulation TR TC 009/2011 draws its inspiration from the European legislation (a negative list of substances that are prohibited in cosmetics, a restrictive list of substances which cosmetic products may contain only under certain conditions, and positive lists of the only substances that can be used in cosmetics as colour agents, preservatives or UV filters). However, the text also regulates the pH value of products, their microbiology and various other aspects not detailed in the European Directive 76/768 and its amendments, or in theRegulation (EC) No 1223/2009 which will replace the Directive from July 2013.

Registration procedure

Moreover, while for the majority of products a declaration of conformity is enough, the Technical Regulation TC TR 009/2011 also lists a number of products for which registration is still needed:

– Self-tanners,
– Skin bleaching products,
– Products for tattoo,
– Hygiene products,
– Cosmetics for children,
– Hair dyes and professional products for hair perms and hair straightening,
– Hair removal products,
– Peels,
– Oral care products,
– Teeth whiteners.

For these products, the registration is a prerequisite for the placing on the market. For imported products, it must be completed prior to clearance the Union’s customs.

The registration procedure consists of three main steps:

1. Evaluation of the technical and administrative file provided by the manufacturer, which includes a Certificate of Free Sale, a GMP statement or the corresponding ISO certificate, the composition of products, labels or their draft in Russian signed and stamped by the manufacturer or an authorized representative of the manufacturer, samples, etc.. [2]
2. Toxicological testing and clinical trials in laboratories accredited according to the regulations of the Customs Union
3. The recording of the product’s and manufacturer’s data as well as test results in the single sanitary database of Customs Union;

Then the registration certificate is issued, it is valid for the entire life of the product.

Declaration of Conformity

For products that are not subject to registration, a declaration of conformity is sufficient. This can be done only by legal entities registered in Russia or in other countries of the Customs Union.