Why a product in the UK/EU doesn’t need to claim it is safe?

Product safety is an integral part of the overall product journey to market. The Cosmetics Regulation* in both the EU and the UK ensures a rigorous process by designating responsibilities to ensure all cosmetic products are safe for human health when used under normal or reasonably foreseeable conditions of use.

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Article 3 lays out the grounds for safety based on the following aspects of a cosmetic product:

(a) presentation including conformity with ‘the Food Imitations (Safety) Regulations 1989’;

(b) labelling;

(c) instructions for use and disposal;

(d) any other indication or information provided by the responsible person defined in Article 4.

All products placed on the market must have a safety assessment carried out by an appropriately qualified safety assessor ensuring that the cosmetic product is safe for humans under normal and reasonably foreseeable use of the product. The safety assessor will check a range of attributes of the product that contribute to its safety including the following list;

• the cosmetic product formula (its qualitative and quantitative composition ensuring that ingredients in the product formulation are at permitted levels if they are restricted and not banned in the EU/UK),

• raw material and finished product specifications

• microbiological quality and the results of the preservation challenge test (if product is aqueous)

• stability of the product

• compatibility of the product with the packaging,

• impurities, traces and information about the packaging material

• normal and reasonably foreseeable use of the product,

• exposure to the cosmetic product and the substances

• toxicological profiles of the substances used,

• undesirable effects and serious undesirable effects

• any other information on the cosmetic product that may be available to the product manufacturer.

After reviewing the above, the safety assessor will conclude whether or not the product is safe and compliant to be sold in the EU/UK market. The safety assessor’s conclusion will include scientific reasoning to support their decision and this will be included in the second part (part B) of the safety report. So, if product safety is built into the regulation, why do we sometimes see claims such as ‘extra safe’ or ‘safe for skin’ on our cosmetic products?

Under UK/EU Cosmetic Regulation claims made regarding a cosmetic product (labelling, advertising, text, names, trademarks, pictures and other signs) shall not imply that the product has characteristics or functions that it does not.

Any product that is regulated under the Cosmetics Regulation, must also comply with Commission Regulation 655/2013 which lays out the 6 Common Criteria for Cosmetic Claims. This includes the following:

1. Legal compliance

2. Truthfulness

3. Evidential support

4. Honesty

5. Fairness

6. Informed decision making

Claims should only be made if they are in compliance with all 6 criteria. Claiming that a product is safe is in breach of first criteria on the list as in essence product safety is a legal requirement for all cosmetic products. It goes hand in hand with many of the other requirements of a claim, that any claim should not be made to confuse or mislead the consumer. Claiming that a product is safe may lead a consumer to believe that a product that is abiding by the law and not making safety-related claims, is unsafe.

Free from claims

This leads on to the question of "free from" claims and whether these types of claims are abiding with the law. Annex III of the Technical Document on Cosmetic Claims is a guidance document from the EU Commission that provides clarification on how the 6 Common Criteria apply to 'free from' claims. It’s clear from this document that free from claims should only be present when they allow an informed choice to a specific target group or end users. For example, free from alcohol in a mouthwash intended to be used by the whole family would be allowed. However what we commonly see infringes on the other common criteria permissible for claims, for example making ‘free from’ claims concerning ingredients which are already prohibited for use in cosmetics by the regulation or ingredients that are not commonly present in the product.

Moreover, we commonly see free from claims mainly based on a presumed negative perception on the safety of the ingredient. For example, parabens are a preservative widely used in cosmetics to prevent the growth of microbes and are a safe to use, authorised substance. However, because of the negative and misleading press they’ve had, they have acquired a bad reputation and it is common to see ‘paraben free’ claims on cosmetics reinforcing this message. It could therefore be argued that based on the fairness criteria, free from paraben claims should not be supported as a product is not made any safer due to the absence of parabens.

The cosmetics regulation ultimately states that all ingredients permitted for use in cosmetic products must be safe. In the EU, safety of ingredients is regularly reviewed by the Scientific Committee on Consumer Safety (SCCS), a group of scientists who provide opinions on the health and safety risks of non-food consumer products (i.e. cosmetics) and services to the EU Commission. This ensures that all ingredients available to use in cosmetics at permitted levels are safe.

Based on this, and the many other factors discussed that contribute to the safety of cosmetics, safety related claims should not be made on cosmetics.

Laila Manshi