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Legislation and Regulations

What is a cosmetic product?

The Act defines cosmetic products as follows: “All substances or mixtures intended to be brought into contact with the external parts of the human body surface (epidermis, body hair, hair, nails, lips and external genital organs) or with the teeth and the mucous membranes of the mouth with the exclusive or primary objective of cleaning them, perfuming them, changing their appearance and/or protecting said body parts, keeping them in good condition or correcting body odors”

In short, a product has to comply with three requirements in order to be cosmetic:

  • The product is a substance or a mixture;
  • The product comes into contact with the external parts of the human body’s surface;
  • The products’ function is cleaning, perfuming, changing the appearance, protecting or keeping in good condition, and/or correcting body odors;

Who is responsible for a cosmetic product?

Each cosmetic product on the European market is coupled to a ‘responsible person’. This person brings a new cosmetic product onto the European market for the first time. The responsible person carries the full responsibility for a cosmetic product. He/she should ensure that the cosmetic product complies with all safety and legislative requirements. The responsible person is further obliged to be domiciled? in the European Union and must warn the local authorities as soon as problems arise with a product.

Who monitors the cosmetics market?

Every Members State in Europe takes its own responsibility for complying with the prescriptions of the Cosmetics Regulation. The Dutch Food and Consumer Goods Product Safety Authority (NVWA) is the monitoring authority for cosmetics products in the Netherlands. The NVWA performs inspections on cosmetics manufacturers and sellers. They check the paperwork (the Product Information Files) and take samples from factories. The NVWA performs random tests. The NVWA also monitors a company when problems arise with a product. In case of transgressions, the NVWA may determine if fines will be imposed and in what form. In cases of minor transgressions, these will mostly be financial fines. In cases of more serious transgressions, the NVWA may decide that a cosmetic product has to be withdrawn from the market.

No approval is required from the NVWA or any other authority before a cosmetic product is brought onto the market. Controls are only exerted after the product is already on the market.

With which legal requirements does a cosmetic product have to comply?

The most important legal obligations for a cosmetic product pertain to the safety and traceability of a cosmetic product.

Before a cosmetic product is brought onto the market, the following has to be complied with:

  • A Product Information File has to be compiled for the product.
  • A qualified assessor should conduct a safety assessment as part of the file.
  • The product has to be notified at the CPNP (Cosmetic Products Notification Portal), the online database of the European Commission.
  • The product’s label should comply with the legal requirements.

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What information should a Product Information File contain?

The Product Information File (PIF) should contain all information available pertaining to a cosmetic product. The PIF includes information on the following:

  • Formulation (quantitative and qualitative composition);
  • Physico-chemical and microbiological specifications;
  • Information about raw materials;
  • Production method;
  • GMP Certification;
  • Safety assessment;
  • Labeling;
  • Proof of the product’s claimed effectiveness;
  • Data about possible adverse side effects;
  • Post-marketing surveillance plan;
  • Declarations of non-use of animal testing

At the request of the authorities, the entire PIF should be available for inspection at the address of the person responsible within three days.

What should be on the label of a cosmetic product?

The label of a cosmetic product should, in all cases, contain the following:

  • Product features (unless this becomes clear from the presentation form)
  • Nominal content of the package
  • Name and address of person responsible
  • Sustainability
  • List of ingredients, listed in descending order of concentration.
  • Batch/production number
  • Special precautions for use, as specified in appendices III through VI of the Cosmetics Regulation 1223/2009/EC

Claims on the packaging of a cosmetic product are only permitted if there is scientific proof of the truth of such claims.

Cosmestic product or not? About borderline cases.

In the case of many products, it is not always immediately clear what type of product this is. There is also uncertainty as to the legislation under which the products fall and what the corresponding safety and quality requirements are.

There are quite a few laws bordering on cosmetics legislation:

  • Medical device legislation (93/42/EC); any instrument, appliance, application, software, material or other article whose function is to diagnose, prevent, monitor, treat or alleviate a disease, injury or handicap, or that is a contraceptive. The primary objective is not attained by pharmacological, immunological or metabolic processes.
  • Pharmaceutical legislation (2001/83/EC); substances preventing and curing diseases. Medications attain their primary objective by means of physiological effect.
  • Biocide legislation (98/8/EC); substances that combat harmful organisms.

In borderline cases, the legislation with which products must comply is determined on a case-by-case basis. This may vary depending on the expected use, the function of the product, and even the manner in which the product is presented. The latter may change. Thus, products that are the same may fall under various types of legislation, depending on the manner of presentation.

An example of a borderline case is hand soap. Depending on the function, the product may fall under various types of legislation:

  • Product is intended to clean hands: cosmetics legislation.
  • Product is intended to disinfect hands: the substance contains a biocide and falls under the biocide legislation.
  • Product is intended for pre-operative use: medical device legislation.

Another example of a borderline case is mouthwash. If the mouthwash contains alcohol and is presented as a disinfectant, the mouthwash falls under the medical device legislation. If the product is presented as cleansing or in order to have fresh breath, it falls under cosmetics legislation.

Laws and Regulations

Doubts about legislation.

Do you know what legislation applies to your product? Please contact us for advice.

Where do I find the complete Cosmetics Regulation?

The complete Cosmetics Regulation 1223/2009/EC can be found on the European Commission’s website.

Click here for the legislation in Dutch.

Click here for the legislation in English.

Couldn’t find what you were searching for?

Read more about the legislation and cosmetics in the SkinConsult information package; download free of charge and without obligation. Alternatively, send us your question.

Formulation

What ingredients may I use in a cosmetic product?

The Cosmetics Regulation contains appendices with lists of chemical substances that are allowed or not allowed to be used in cosmetics. The different appendices contain substances based on their function:

  • Appendix II – Prohibited substances: these are not allowed to be used in cosmetics. These include medications, biocides and hormones.
  • Appendix III – Restricted substances: conditionally allowed for use in cosmetics. The conditions for use are specified in the appendix.
  • Appendix IV – Colorants: only the colorants on this list are allowed for use in cosmetics. Others are not. This list also specifies the conditions for use.
  • Appendix V – Preservatives: as in appendix IV.
  • Appendix VI – UV-filter: as in appendices IV and V.

What preservatives may I use?

Appendix V to the Cosmetics Regulations 1223/2009/EC defines what preservatives may be processed in cosmetic products. The maximum concentration per preservative is also indicated. Appendix V is a positive list; all the substances on this list are therefore allowed in cosmetics. If a preservative is not included, the use of the substance in a cosmetic product is prohibited.

Click here for the European Cosmetics Regulation.

Do you need advice about the use of preservatives? Are you looking for a preservative but are unsure as to what substance is best suited to your product? Please contact us for advice on cosmetics formulation.

What are the regulations for nanomaterials in cosmetics?

Additional safety measures have been established for cosmetic products that contain nanomaterials in order to protect public health. Various nanomaterials have been assessed for safety. These are contained in the appendices to the Cosmetics Regulations. There is no specific list for nanomaterials; nanomaterials have been included in one of the appendices depending on their function. For these nanomaterials, it has already been established whether or not they may be used in cosmetics, and in what concentrations. A nano-variant of a chemical substance may only be used in cosmetics if this has been explicitly stipulated in the laws.

You should consider a number of issues if you want to bring a cosmetic product with nanomaterial onto the market:

  • You should report the use of nanomaterial in the product notification;
  • You are obliged to indicate the nano-ingredients on the product’s label by placing the term “(nano)” after the ingredient.

New nanomaterials that were not used previously in cosmetics. These have not been assessed for safety by the European Commission and are therefore not described in any of the appendices to the Cosmetics Regulation. You should provide information about the safety of a nanomaterial if you want to use a new nanomaterial in a cosmetic product. This can be done together with the product notification. The European Commission may conduct a scientific assessment of the safety information. It is therefore recommended that a cosmetic product with a new nanomaterial be notified six months prior to marketing.

How should I label perfume ingredients?

Perfumes may contain allergens. To facilitate contraindication for patients and correct diagnosis for physicians, it is necessary to declare the use of perfume on the product label.

Placing the term “Perfume” or “Aroma” on the label would suffice for most perfumes. However, a number of perfume substances are allergenic to such an extent that they have to be indicated separately on the label. If you use a perfume substance that contains one of these allergens, you will have to specifically stipulate this substance on the product’s label and/or packaging. The substance should be stipulated in the INCI name.

There are currently 26 perfume allergens for which separate stipulation is obligatory. However, the number is planned to be increased to 89. It is still unclear as to precisely how the notification is to be made. A proposal as to how to declare the perfume allergens is expected from the European Commission by the end of 2014.

Click here for the European Commission’s list with the 26 perfume allergens that have to be declared separately.

May I use microbeads in cosmetics?

The use of microbeads in cosmetics is allowed under existing European legislation. Microbeads, or microplastics, are small plastic balls made from polyethylene, polypropylene and/or nylon-12. The function of the microbeads is to scrub the skin.

Over the years, concerns have developed about the use of microbeads in cosmetics. Microbeads do not cause any direct damage to people’s health but are assimilated in waste water. A large part is filtered out and incinerated by water purification plants. The incineration of filtered microbeads is harmful to the environment. Another part of the microbeads ends up on the water surface. There are some indications that microbeads cause harm to ocean fauna.

The Netherlands took the lead in reducing the use of microbeads in cosmetics. State Secretary for Infrastructure and the Environment, Wilma Mansveld, is currently busy preventing the use of microbeads both in the Netherlands and in Europe. In the Netherlands, this is being done through the Dutch Cosmetics Association (NCV). All members of the NCV have stopped using microbeads and are committed to work towards a production line completely free of microbeads. This objective would be reached by 80% of the NCV members by the end of 2017.

There is no legal European prohibition on the use of microbeads in cosmetics. Attempts in that direction are being made by means of various campaigns, including that of State Secretary Mansveld.