Cosmetics Products Safety Regulations -- EU Regulations

The European Union (EU) has long strived to ensure safe and high-quality products, as well as to harmonize the relevant standards between all 28 member states. This allows products to move easily between EU member states.

Few products move faster from market to market than cosmetics. Throughout Europe, the cosmetics market continues to thrive, with 2017 seeing the industry reach 77.6 Euro ($89.5 billion) in sales.

The manufacturing and sale of cosmetics within the EU are regulated under Regulation EC 1223/2009, which took full effect in 2013, replacing Directive 76/768/EC and introducing key changes meant to make safety standards and responsibility demands more robust.

EU Defines ‘Cosmetic’

Regulation EC 1223/2009 defines cosmetics as: “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, correcting body odours.”

Some products, like aromatherapy products, might contain both cosmetic and medical properties and are an example of a “borderline product” which should be assessed on a case-by-case basis as to its required regulatory standards.

Changes to the Original Standard

• Before marketing your cosmetics product, it is necessary to prepare a product safety report.
• The new regulation defines terms for a “responsible person” and permits only an identified “responsible person” to bring a cosmetic product to the market.
• Manufacturers must notify the EU directly before marketing a cosmetic product. This is to be done through the Cosmetic Product Notification Portal.
• Responsible persons are required to notify national authorities concerning any serious undesirable effects (SUE) detected in their cosmetic product.
• Specific authorization and labeling standards are required for nanomaterials, including the use of the term “nano” on product labels to accompany the type used. Ex: “titanium dioxide (nano).”

Maintaining Product Information Files

The responsible person is required to keep a technical information file of each product for a minimum of 10 years after the initial batch production. The file should include:

• A description of the cosmetic product;
• A corresponding safety report;
• Description of your manufacturing method and Good Manufacturing Practice (GMP) compliance;
• Proof of your product’s effectiveness against your product claim;
• A declaration and results of all prior testing which included the use of animals.

Labeling

Individual Member States determine the language in which all cosmetic product labeling must be presented, but the fundamental requirements are the same across the EU:

• Name and address of the responsible person
• Country of origin for all imported cosmetics
• Product expiration date under reasonable conditions
• Weight or volume of the cosmetic at the time of packaging
• A corresponding batch number of the product
• Prescribed precautions for product use
• Supplemental explanation of any unclear aspects of the product
• An ingredient list: in order by weight at time of inclusion into the cosmetic.

Consequences of Non-Compliance

When competent authorities have determined that a cosmetic product does not comply with the standards established by EC 1223/2009, they are authorized to take necessary corrective action against the responsible person, including, but not limited to: mandating that corrective action be performed to obtain compliance; requiring a product recall; and requesting a report of remedies for non-compliance issues from the responsible person.

If a remedy to a non-compliant product has not been carried out by the responsible person, competent authorities will notify the Member State in which the product is marketed and call on them to take necessary action -- which will likely result in the product being recalled and withdrawn from further marketing.

Sampling and Testing

EU legislation establishes that “the sampling and analysis of cosmetic products shall be performed in a reliable and reproducible manner.” In other words: accuracy of results against established testing methods; testing validity to adequately replicate real-world conditions; and consistency.

As your cosmetics product will be held to the above standards, you, in turn, depend on your manufacturing plants to be able to accurately and consistently carry out your design in a way that keeps each unit of your batch safe for use and safe from factory contaminants.

Therefore, to ensure that your product is safe for your consumers and compliant with the relevant regulations, your chosen cosmetic safety testing lab service should also be able to meet all of your expectations for accuracy, validity, and consistency.

QIMA stays current on all national and international testing standards for cosmetics; maintains 3 in-house labs and a global network of preferred lab partners; and can deliver consistent, accurate test results so you can monitor consistency on the factory floor.

When you work with experienced lab technicians and market specification experts like QIMA, you are ensuring that all pre-market requirements, such as proper labeling and record keeping, are consistently being met, and no defect or non-compliance slips through the cracks.

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