As it is known, the Technical Regulations on Cosmetic Products (hereinafter referred to as the Technical Regulations) shall come into effect on August 3, 2024. Responsible manufacturers of cosmetic products have already started preparing documentation to confirm the compliance of their cosmetics with the Technical Regulations' requirements.
The need for early preparation arises because the new procedures significantly differ from the previous regulatory framework when obtaining a sanitary and epidemiological conclusion (hygienic certificate) was sufficient for cosmetic products to enter the market.
In should be noted that due to the implementation of the Law of Ukraine "On the Public Health System," the Law of Ukraine "On Ensuring Sanitary and Epidemiological Well-being of the Population," which stipulated the issuance of a sanitary and epidemiological conclusion (hygienic certificate) for cosmetics, has been repealed.
On necessity of certification under standard DSTU EN ISO 22716:2015
While preparing the documentation required by the Technical Regulations for the products of one of our clients, a foreign manufacturer of cosmetic products, the issue of confirming compliance with Good Manufacturing Practice (hereinafter referred to as GMP) arose.
According to clauses 21-22 of the Ukrainian Technical Regulations, cosmetic products manufacturing is required to adhere to GMP. The list of national standards identical to the relevant harmonized European standards is ratified and disclosed in line with the Law of Ukraine "On Technical Regulations and Conformity Assessment." Compliance of production with national standards that are identical to harmonized European standards implies a presumption of compliance of such production with GMP.
The harmonized European standard is EN ISO 22716:2007 standard developed by the International Organization for Standardization.
According to clause 1 of Order of SOE "Ukrainian scientific research and training center for standardization, certification and quality problems" No. 198 of December 21, 2015, DSTU EN ISO 22716:2015 is the national standard in Ukraine harmonized with international and European regulatory documents in the fields of cosmetics.
Considering Part 1 of Article 1 of the Law of Ukraine "On Technical Regulations and Conformity Assessment," the procedure involving the confirmation of compliance by a third party with regard to products, processes, services, systems or personnel is referred to as "certification."
Therefore, compliance of cosmetics manufacturing with Ukraine's national standard DSTU EN ISO 22716:2015, confirmed through certification, provides a presumption of compliance with GMP, as required by the Technical Regulations.
At the same time, some theorists and practitioners maintain the attitude that the GMP certification procedure will not be mandatory even after the Technical Regulations comes into effect, as it does not explicitly require certification, but rather specifies only the obligation to comply with GMP.
Indeed, the Technical Regulations do not stipulate that certification for compliance with standard DSTU EN ISO 22716:2015 is mandatory. Meanwhile, according to clause 29 of the Technical Regulations, the responsible party must ensure the availability of documentation for cosmetic products to the state market surveillance authority (which will be the State Service of Ukraine on Medicines and Drugs Control).
This means that upon request from the State Service of Ukraine on Medicines and Drugs Control, the responsible party will be required to provide a statement of compliance of cosmetic products manufacturing with GMP, which in Ukraine is confirmed by a certificate of compliance with DSTU EN ISO 22716:2015.
Having the relevant certificate for the manufacturer will serve as proof of GMP compliance and will significantly reduce the time and effort of the responsible party in proving the compliance of cosmetic products manufacturing with the specified requirements to the State Service of Ukraine on Medicines and Drugs Control.
On use of foreign certificates in Ukraine
Returning to the practical case, as evidence of compliance with the GMP, the client provided a certificate that affirmed its alignment with the national standard of the manufacturer's country.
However, as stated before, the Technical Regulations specify compliance of cosmetics production with the national standard, that is, the Ukrainian standard DSTU EN ISO 22716:2015. This raises the question: can a foreign certificate be used to confirm the compliance of cosmetic products manufacturing with GMP in Ukraine?
Following the information from Ukrainian certification agencies, recognition of certificates for compliance with foreign standards based on EN ISO 22716:2007 is not carried out in Ukraine. However, there are regulatory grounds for the automatic recognition of foreign certificates in Ukraine.
According to Part 6 of Article 14 and clause 23 of the preamble of Regulation (EU) No. 765/2008, the European co-operation for Accreditation (hereinafter referred to as EA) is the agency managing the peer evaluation system among the national accreditation bodies of the EU member states and other European countries. Within the EA, there is a Multilateral Agreement (hereinafter referred to as EA MLA), the signatories of which recognize each other’s accreditation systems as equivalent.
Taking into account the information on the EA website, the EA MLA has been signed by the National Accreditation Agency of Ukraine, specifically in the field of "Management Systems Certification."
Thus, if the event of a country of a foreign manufacturer signing the EA MLA, certificates issued by accreditedcertification agencies in that country may be considered equivalent in Ukraine. In other words, they can confirm compliance with GMP for cosmetic production, as required by the Technical Regulations.
In the case of the client, it was discovered that the certificate for GMP compliance was issued to a foreign manufacturer by a non-accredited agency. Consequently, such a certificate cannot be considered equivalent in Ukraine.
Therefore, in the event of a similar situation for a foreign manufacturer of cosmetic products, the effective way to confirm the compliance of the cosmetic production with GMP is to undergo certification for compliance with standard DSTU EN ISO 22716:2015 in Ukraine.
If you have any questions about placing cosmetic products on the market in Ukraine in accordance with the requirements of the Technical Regulations on Cosmetic Products, please contact Lidiia Sanzharovska, Counsel at Legal Alliance sanzharovska@l-a.com.ua.
The event focused on the transformation of Ukraine's intellectual property sector on its path toward European integration.
Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities. SAFEMed Activity (2017-2025) has supported this effort by appIying health system strengthening best practices.
The Ministry of Health website has posted a notice about the release of a revised draft order of the Ministry of Health ‘On Approval of Amendments to Certain Re
On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.
