Interpretation of Transitional Measures regarding Safety and Technical Standards for Cosmetics

On 1 June 2016 CFDA formally released an announcement specifying the transitional measures for implementing Safety and Technical Standards for Cosmetics. The announcement clarified relevant measures and deadlines for the implementation of the new standard, which are almost the same as reported by a Chemlinked at the end of May (CL news). Formula “For already approved or filed cosmetics, the manufacturers and importers should submit modification applications to CFDA before 1st Dec 2016. Domestic non-special cosmetics only require submission of new formula and packaging while other categories require submission of description and diagram of the production process, safety assessment report (for risk-concern substance) and testing reports together.” However testing reports could be a big problem for manufacturers/importers applying for modification. At present almost all the accredited testing institutions do not conduct related testing according to the new Standard, so the

Take home

Formula

“For already approved or filed cosmetics, the manufacturers and importers should submit modification applications to CFDA before 1st Dec 2016. Domestic non-special use cosmetics only require submission of new formula and packaging while other categories require submission of description and diagram of the production process, safety assessment report (for risk-concern substance). Depending on the circumstances testing reports will require submission if there is a need.”

However testing reports could be a big problem for manufacturers/importers applying for modification. At present almost all the accredited testing institutions do not conduct related testing according to the new Standard, so the testing reports may be unacceptable by the CFDA. Generally it takes two months to obtain a testing report in China. If the institutions don’t implement the new standard before Oct 1st, manufacturers/importers will miss the deadline and suffer losses. Applicants are recommended to consult the testing institutions about the implementation status prior to appointing them to conduct testing.

Technical Documents

“For already approved or filed cosmetics that fail to meet the requirements for quality control specification and product technical specification set by the new standard, the relevant manufacturers/importers should finish the technical adjustments before 1st Dec 2016 but can keep the files themselves for future inspection. If there is a need to apply for modification or renewal of license, those files shall be submitted together.”

For imported cosmetics both Chinese quality control specification and original language quality control specification require revision. Importers are advised to revise the original quality control specification in a timely manner to avoid disruption to production and sale.

Labeling and Packaging

“For already approved or filed cosmetics that fail to meet the requirements for application conditions and warnings, original packaging can be used before June 30th 2017 and products can be sold before the expiration date. The relevant manufacturers/importers can submit the revised labels or packaging when applying for modification or renewal of license. Domestic non-special use cosmetics manufacturers shall timely submit the new label and packaging via online filing platform prior to make the changes on their products.”

It shall be noting that the rules are only applicable to cosmetics subject to revised application conditions and bearing associated warnings. For revision of ingredient lists, manufacturers/importers are subject to the transitional measures relating to formula and shall prepare and submit related documents on time.

The transitional measures in the release are still incomplete and problems will arise during the actually process of compliance. There may be the release of additional measures to supplement them later this year. Stay tuned for more relevant information on CL.