Draft Regulations on Cosmetic Products Safety: Legal Opinion

Alexander Yanev, Associate with Legal Alliance Company

The European integration way, followed by Ukraine nowadays, is rather harsh and complex. Nonetheless, it has positives features too. Particularly, it concerns the issue of Ukraine’s legislation localization and harmonization in compliance with the EU legislation. The regulation of cosmetics circulation in our country is currently discussed. Taking this into account, in 2013 the Ukraine’s MoH ordered the PE “The State Expert Center of the Ministry of Health of Ukraine” to coordinate the appropriate standard regulation formation. The document formation process was joined by the European Business Association, American Chamber of Commerce in Ukraine, Ukrainian Direct Selling Association and other involved parties.

If taking into the account the analysis of the Ukraine’s cosmetics circulation, it’s possible to identify a range of problems in cosmetics manufacturing and realization, as long as the current safety requirements are unstructured.

The draft Regulations developers’ point is that regulating the cosmetics circulation in Ukraine can change after this very document comes into force, as well as after implementing the European approach to the produced cosmetics controlling, i.e. the transmission of the control from the manufacturing stage to the stage of introduction to the market, which enables to minimize the state’s interference into the economic operator’s activity.

Despite the positive aspects associated with the prospect of the regulations adoption, the draft document requires substantial revision, particularly with regard to the following factors:

1) in accordance with the current legislation of Ukraine, regulations are the Ukraine’s law or the legal act adopted by the Cabinet of Ministers, which defines the characteristics of products or related processes and production methods, as well as service requirements, including relevant provisions, compliance of which is compulsory. It may also include requirements to terminology, symbols, packaging, marking or labeling as they apply to a product, process or production method. Due to this the regulations include very controversial provisions governing the state registration of the pre-sale notice;

2) requires revision and terminology used in the draft Regulations. At least, the terms, used therein, shall comply with the applicable legislative acts of Ukraine in order to prevent them from being interpreted differently. In particular, this applies to the following terms: "Minimum shelf life", "final consumer", "homogeneous products ", " cosmetic products quality ", etc.;

3) one of the Draft Regulations borrowings was the need to inform whether the cosmetic products contain nanomaterials (insoluble or biologically resistant and specially produced materials from at least one external dimension or an internal structure in the range of 1 to 100 nm).

Regulations No. 1223/2009 EU "On the cosmetic products" (hereinafter - Regulations EU No. 1223/ 2009) provides an indication imperative that all components in the form of nanomaterials shall be clearly indicated in the list of ingredients. Moreover, for the names being clearly identified, the following components must be accompanied by the word ' nano ' given in brackets.

Technical Regulations EU No. 1223/2009 also require the compulsory notification (in electronic form) on products containing such substances to the European Commission. Data on nanomaterials are in the public domain and should be regularly updated, which is an absolute plus for consumers. In addition, in the event of a threat to the health, circulation of nanomaterials-containing cosmetic products will be banned.

Although the draft regulation actually repeats the Technical Regulations EU No. 1223/2009, but as for the nanomaterials, the Ukrainian legislator confined himself to the provisions of the necessity to manufacture such goods in compliance with the high level of health protection, as well as a reference to the not yet existing special regulations, linked to the circulation of cosmetic products containing nanomaterials;

4) besides, there are rather controversial provisions that require the state registration of pre-sale reports of cosmetic products circulation, which creates additional barriers to its introduction to the market. Recalling that the EU regulations No. 1223/2009 provides declarative notification procedures (by sending email);

5) despite numerous disadvantages of the draft regulations, we consider the EU Regulations No. 1223/ 2009 provisions as for decision makers to be rather positive. Placing responsibility for the accuracy of information on products at the manufacturer and obliging him to make detailed information on the composition and possible effects of such products prior to its issuance, the developer improves product quality and real protection of public health.

We consider it to be very important to introduce a transitional period before the entry into force of technical regulations on cosmetic products safety. The above-mentioned analysis will allow all network operators to prepare properly and bring their activities into compliance with the new requirements.

The adoption of this document will definitely have several positive effects:

• First, economic operators and consumers will get the legal basis for high-quality and safe cosmetics import and sale in our state;
• Second, shadow players will be complicated with the opportunity to import counterfeit cosmetics into Ukraine and putting them into circulation;
• Third, our country will make another step forward in the adaptation and harmonization of national legislation with the EU law.