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Cosmetics Proved and confirmed in Russia

BIOX.CN 2006-3-30 9:15:54 来源:生命经纬
 

With increase in population welfare, consumer preferences shift towards middle market and price incentives cede in importance to production quality. This tendency is certainly interesting for foreign companies both for those working in Russia for a long time and those just entering the territory.

Product legalization on the Russian market is among the first and foremost tasks an exporter has to fulfil. Legalization procedures for perfumery and cosmetics market are under control of correspondent legislative acts and certification is the most important part of the process.

Perfumery and cosmetics production is certified by two ways: sanitary-epidemiological evaluation (made in the first instance) and certification according to GOST R system.

The following organizations take part in sanitary-epidemiological evaluation of a product.

  • Ministry of Health. Its responsibility includes accreditation of certification authorities and defining the list of products liable to certification in Federal Inspection on Protection of Consumers and People Well-being
  • Federal Inspection on Protection of Consumers and People Well-being
  • Certification authorities. They are responsible for identification of production, certification and licensing as well as further inspection of production certified
  • Testing laboratories. They effect physic-chemical, toxicological, microbiological tests and make reports for the purpose of certification

The Regulation #325 of Ministry of Health, August 15, 2001 and its amendments enact the procedure of sanitary-epidemiological certification. The regulation contains list of products obligatory for the valuation (all perfumery and cosmetics is included into the list). The following positions are the subject to certification only in Federal Inspection on Protection of Consumers and People Well-being.

  • Creams, masks, pilling products, hair balms made for professional usage in beauty salons
  • Auto-tanning products, skin whitening creams, products for tattooing without injection, intimate hygiene means
  • Hair colorants (exc. tint balms)
  • Products for permanent
  • Baby care
  • Oral care (fluoride containing products, teeth whitening pastes, products for denture hygiene)

To obtain a certificate a company can carry out all the requirements on its own or engage a specialized consultant for assistance. In both ways you need to attach to your application samples of products and the following documents.

  1. Product safety confirmation from manufacturer
  2. Safety certificate given by authorized organization in the country of manufacturing
  3. Testing reports (if available)
  4. Technical description of ingredients, composition and usage
  5. Samples of labels
  6. Contract on the production supply

All the documents have to be translated in Russian and copies need to be attested.

In general case the procedure of sanitary-epidemiological evaluation comprises the following stages.

  • application for certificate with all required documents attached
  • consideration of the documents applied
  • testing of samples (physic-chemical, toxicological, microbiological and clinical)
  • examination of testing reports
  • delivery of sanitary-epidemiological (hygienic) certificate or registration document by Ministry of health and social development of Russian Federation

Terms of expertise depend on type and volume of research. Normatively the process takes two months. Hygienic certification is given “to provide sanitary-epidemiological well-being of population and prevent penetration of dangerous production in the country” (quoted Regulation #325 of Ministry of Health).

Several types of products are approved for effectiveness. Firstly, it is evaluated for safety, secondly clinical testing with participation of volunteers are conducted. A group of volunteer comprises twenty people minimum. Unofficial resource unveiled cost of the testing equal to $10-15 for one person per day.

Sanitary-epidemiological certificate is valid for 1-5 years (at the discretion of authorities). Registration document by Ministry of health has no time limit.

Successful accomplishment of hygienic expertise allows further certification in GOST R system. GOST R is made to confirm consumer characteristics of a product comply with requirement of manufacturer’s and national normative documentation. This procedure is regulated by the Order #11 of Gosstandart, February 2, 2001. The order prescribes several schemes of imports certification, divided in two groups.

  1. Certification of an imported production batch (documentation has to be applied by a Russian partner, for example distributor)
  2. Certification of serial production

General procedure of product evaluation in GOST R system is analogical to the above-described sanitary-epidemiological one. The procedures differ only in the subject of evaluation. It should be mentioned, that certain schemes of certification implies expert estimation of manufacturing facilities.

Certificate for a batch may be valid up to two years, though usually terms of validity are equal to one year. This document may also be termless, but in this case number of batches has to be accurately stated.

Certification of serial production is given by application of a manufacturer. Its terms of validity may not exceed three years. If a company pretends to obtain the three-year certificate, manufacturing facilities expertise is indispensable.

As you may see, the certification procedure is quite complicated. Though without a certificate production batch will not even undergo all the customs formalities. It’s your choice whether to ask a consultant agency for assistance or detach your own specialist to accomplish the process. Time and efforts of your specialists may occur more requiring than certification outsourcing. You may find assistance in the person of a specialist working for certificate authority or hire an agency dealing in quality consultancy and providing certificate services as a by-product. However, in the latter case you have to be careful, because swindlers happen among consultant agencies. Law is invariable for everyone, thus if a consultant offers you to get a certificate without a complete profile of documents basing only on declarative application and letters of guarantee and containing no technical characteristics of a product, such a certificate is invalid. In some cases a consultant can not significantly influence the process of certification, especially the expertise conducted in Federal Inspection on Protection of Consumers. However a high-quality monitoring made by an experienced professional is always helpful in avoiding unjustified delay.




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