The European Commission has adopted guidelines setting forth its expectations for how cosmetic manufacturers and importers should comply with safety-assessment requirements under the EU’s recently launched Cosmetics Regulation.

Published Nov. 26 in the Official Journal of the European Union, the Commission Implementing Decision is intended to “facilitate understanding” and help firms meet the mandates of the regulation’s Annex I, which requires manufacturers or importers to establish in a product safety report that a cosmetic product is safe under normal and reasonably foreseeable conditions before it can be placed on the market.

The regulation, which went into force in July, provided a general framework for safety assessments but did not expand on how that information could be collected or detail the types of data that should and should not be included in the assessment.

The new guidelines were developed with industry stakeholder input and launched in mid-December.

Under the guidelines, designated responsible persons collecting and reporting data for part A of the report can use “any reliable source” to demonstrate safety including “data from suppliers, scientific literature, experience gained with similar or other product categories, results of studies on the product itself or on the substances it contains, available data on similar formulations or computer models.”

The regulation already dictated that safety must be demonstrated for a number of areas – including quantitative and qualitative composition of the cosmetic product – and recommended that the responsible person state the name and qualitative identity of each raw material and the amount of each raw material used.

However, the guidelines provide additional color to assist in the compilation of that information. When recording the amount of raw material in a product, “ranges should not be used, unless this can be justified,” the decision states. Additionally, “if concentration ranges are unavoidable, toxicological considerations and calculations should be based on the highest concentration figure.”

The implementing decision additionally underscores the importance of required physical/chemical characteristics and stability data, noting they are “crucial” for an appropriate safety assessment as they may influence the safety of the cosmetic product.

For example, “physicochemical properties, in combination with other information, can help the safety assessor determine the need to investigate relevant toxicological parameters.” Moreover, the physicochemical characteristics of the substances or mixtures and finished products “set the benchmark against which the products and the raw materials can be considered acceptable from a quality point of view.”

Also under the physical/chemical properties section, the guidelines add that if formula stability is dependent on storage conditions, information about those conditions should be communicated throughout the supply chain and, if relevant, indicated on the labeling of the product.

Microbial Growth Regs Explained

The EC’s guidelines also explain the importance of assessing microbiological specifications of raw materials and finished products, particularly for products used in sensitive areas of the body, to gauge and account for risks.

Firms must address contamination issues in part A of the required product safety report, and the new guidelines note that “particular attention should be paid to the raw materials (substances and mixtures) most susceptible to microbial growth (e.g. water-based mixtures, protein-rich materials, plant or animal raw materials).”

When traces of impurities or prohibited substances are present, “evidence of their technical unavoidability are also to be provided,” according to the guidelines. In light of contamination concerns, “relevant characteristics of the packaging material are to be considered” as well, the EC adds.

The guidelines also provide recommendations on how companies carry out safety assessments under sections of the regulation regarding exposure risks, toxicological profile of ingredients and serious undesirable effects.

The EC notes that while the resource “should assist responsible persons in complying with their regulatory obligations,” the guidelines “are not meant to replace the knowledge and expertise of the qualified safety assessor … who should remain the only professional allowed to carry out the cosmetic product safety assessment as described in Part B of Annex I.”

The EU’s Cosmetics Regulation was passed in 2009, streamlining the outdated and unwieldy European Cosmetics Directive. The overhaul was intended to harmonize regulations across the EU and instill consumer confidence in product safety Also see "EU Ushers In New Cosmetics Regs; Experts Offer Perspective" - HBW Insight, 29 July, 2013..

New EU Safety-Assessment Guidelines Clarify Cosmetics Regulation

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