The EU Regulation on Cosmetics

Although cosmetics are not as regulated as drugs, there are still some laws that apply to them. Such laws unfortunately vary from country to country but there are also many similar ones. Nevertheless, although such subjects tend to produce very long and boring documents, there is some information in them that is not only interesting but also worth knowing. So bear the long post, this is information YOU SHOULD KNOW, grab a coffee and let’s have a summary look at the European law on cosmetics as stated in the REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL.

All information below is found in this document and is directly quoted when written in “italics”. For all the details click here to be directed to the document which you can access in many different languages!

 

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Definitions

As expected in legal documents, this directive starts by defining all terms such as cosmetic product, substance, UV-filters, colorants, preservatives etc. It’s worth having a look at this document if you ever wanted to know the legal definitions.

For example, let’s take the simplest one: a cosmetic product is defined 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, protecting them, keeping them in good condition or correcting body odours. A substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.

 

Safety

The European regulation states that:

A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following:

(a) presentation including conformity with Directive 87/357/EEC;

(b) labelling;

(c) instructions for use and disposal;

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

 

The “responsible person”

Companies or communities have to designate a “responsible person” who has to accept in writing. In many cases the distributor can be the “responsible person”. A “responsible person” is someone who has to ensure compliance with the EU laws that apply to cosmetics.

However, even if the “responsible person” is not the distributor, the latter still has some responsibilities. The distributor has to make sure that the cosmetic product has the correct labelling information, language requirements, specify the date of minimum durability and that all the above obey the EU laws for their respective subject (for example, the EU law for labelling cosmetics etc).

The “responsible person” also has to ensure that:

the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;

(b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources;

(c) the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.

Before a cosmetic products goes on the market, the “responsible person” also has to submit some information about it to the EU Commision and keep a product information file which should be available at any time up to 10 years after the last batch of the cosmetic and contain:

(a) a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;

(b) the cosmetic product safety report referred to in Article 10(1);

(c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;

(d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;

(e) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

 

Substance restrictions

The document states the following substances restrictions:

cosmetic products shall not contain any of the following:

(a) prohibited substances

— prohibited substances listed in Annex II;

(b) restricted substances

— restricted substances which are not used in accordance with the restrictions laid down in Annex III;

(c) colorants

(i) colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex, except for hair colouring products referred to in paragraph 2;

(ii) without prejudice to points (b), (d)(i) and (e)(i), substances which are listed in Annex IV but which are not intended to be used as colorants, and which are not used in accordance with the conditions laid down in that Annex;

(d) preservatives

(i) preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that Annex;

(ii) without prejudice to points (b), (c)(i) and (e)(i), substances listed in Annex V but which are not intended to be used as preservatives, and which are not used in accordance with the conditions laid down in that Annex;

(e) UV-filters

(i) UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that Annex;

(ii) without prejudice to points (b), (c)(i) and (d)(i), substances listed in Annex VI but which are not intended to be used as UV-filters and which are not used in accordance with the conditions laid down in that Annex.

 

CMR susbtances

The use of CMR substances (Carcinogenic, Mutagenic, toxic for Reproduction) is prohibited unless they’ve been proven to be safe and even then they would still have to fulfil certain criteria.

 

Nanomaterials

The Commision needs to be notified 6 months before placing a product in the market that contains nanomaterials unless they’ve been placed in the market before by the same “responsible person” which will have to submit all relevant information around the material to the Commison, including exact specification of the material, toxicological and safety data.

 

Traces of prohibited practices

The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.

 

Animal testing

The European Comission prohibits placing in the market cosmetic products or cosmetic products containing substances which were animal tested using methods that are not EU approved.

However, an exception can be granted when:

(a) the ingredient is in wide use and cannot be replaced by another ingredient capable of performing a similar function;

(b) the specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research protocol proposed as the basis for the evaluation.

 

Labelling

Probably one of the most applicable to consumers category, a cosmetic product label must have in the following information in indelible, easily legible and visible lettering:

(a) the name or registered name and the address of the responsible person. Such information may be abbreviated in so far as the abbreviation makes it possible to identify that person and his address. If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted. The country of origin shall be specified for imported cosmetic products;

(b) the nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually;

(c) the date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain in conformity with Article 3 (‘date of minimum durability’).

The date itself or details of where it appears on the packaging shall be preceded by the symbol shown in point 3 of Annex VII or the words: ‘best used before the end of’.

The date of minimum durability shall be clearly expressed and shall consist of either the month and year or the day, month and year, in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.

Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product is safe and can be used without any harm to the consumer. This information shall be indicated, except where the concept of durability after opening is not relevant, by the symbol shown in point 2 of Annex VII followed by the period (in months and/or years);

(d) particular precautions to be observed in use, and at least those listed in Annexes III to VI and any special precautionary information on cosmetic products for professional use;

(e) the batch number of manufacture or the reference for identifying the cosmetic product. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging;

(f) the function of the cosmetic product, unless it is clear from its presentation;

(g) a list of ingredients. This information may be indicated on the packaging alone. The list shall be preceded by the term ‘ingredients’.

For the purpose of this Article, an ingredient means any substance or mixture intentionally used in the cosmetic product during the process of manufacturing. The following shall not, however, be regarded as ingredients:

(i) impurities in the raw materials used;

(ii) subsidiary technical materials used in the mixture but not present in the final product.

Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’. Moreover, the presence of substances, the mention of which is required under the column ‘Other’ in Annex III, shall be indicated in the list of ingredients in addition to the terms parfum or aroma.

The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the cosmetic product. Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.

All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.

Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients. For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added. The CI (Colour Index) nomenclature shall be used, where applicable.

 

If a product is small or difficult to package, like a soap for example, it still must include that information on an enclosed or attached leaflet, label, tape, tag or card.

 

Product claims

This is a much shorter category that any of us would have liked but the EU Comission states something quite interesting:

In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.

 

Access of information to the public

Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product are made easily accessible to the public by any appropriate means.

The quantitative information regarding composition of the cosmetic product required to be made publicly accessible shall be limited to hazardous substances in accordance with Article 3 of Regulation (EC) No 1272/2008.

 

In-market control

The EU member states must periodically monitor the cosmetic products by using in-market controls. They must also “monitor compliance with the principles of good manufacturing practices” and review and assess their surveillance activities at least every 4 years.

 

Communication of serious undesirable effects

1.  In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred:

(a) all serious undesirable effects which are known to him or which may reasonably be expected to be known to him;

(b) the name of the cosmetic product concerned, enabling its specific identification;

(c) the corrective measures taken by him, if any.

 

Non-compliance Safeguard clause

The EU member state has the right to remove a product from the market if the “responsible person” is non compliant to the EU cosmetic laws.

 

Annual report on animal testing

Every year the Commission shall present a report to the European Parliament and the Council on:

(1) progress made in the development, validation and legal acceptance of alternative methods. The report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Directive 86/609/EEC. The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;

(2) progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by third countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries;

(3) the manner in which the specific needs of small and medium-sized enterprises have been taken into account.

 

Cosmetic product safety report

The cosmetic product safety report shall, as a minimum, contain the following:

PART A –   Cosmetic product safety information

  1. Quantitative and qualitative composition of the cosmetic product

The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfume and aromatic compositions, description of the name and code number of the composition and the identity of the supplier.

  1. Physical/chemical characteristics and stability of the cosmetic product

The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.

The stability of the cosmetics product under reasonably foreseeable storage conditions.

  1. Microbiological quality

The microbiological specifications of the substance or mixture and the cosmetic product. Particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses.

Results of preservation challenge test.

  1. Impurities, traces, information about the packaging material

The purity of the substances and mixtures.

In the case of traces of prohibited substances, evidence for their technical unavoidability.

The relevant characteristics of packaging material, in particular purity and stability.

  1. Normal and reasonably foreseeable use

The normal and reasonably foreseeable use of the product. The reasoning shall be justified in particular in the light of warnings and other explanations in the product labelling.

  1. Exposure to the cosmetic product

Data on the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to

1) The site(s) of application;

2) The surface area(s) of application;

3) The amount of product applied;

4) The duration and frequency of use;

5) The normal and reasonably foreseeable exposure route(s);

6) The targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken into account.

The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. exposure might need to be calculated per unit area of skin or per unit of body weight). The possibility of secondary exposure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.).

Particular consideration shall be given to any possible impacts on exposure due to particle sizes.

  1. Exposure to the substances

Data on the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6.

  1. Toxicological profile of the substances

Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made.

All significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations shall be duly justified.

Particular consideration shall be given to any possible impacts on the toxicological profile due to

— particle sizes, including nanomaterials,

— impurities of the substances and raw material used, and

— interaction of substances.

Any read-across shall be duly substantiated and justified.

The source of information shall be clearly identified.

  1. Undesirable effects and serious undesirable effects

All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products. This includes statistical data.

  1. Information on the cosmetic product

Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.

PART B –   Cosmetic product safety assessment

  1. Assessment conclusion

Statement on the safety of the cosmetic product in relation to Article 3.

  1. Labelled warnings and instructions of use

Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d).

  1. Reasoning

Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2. This explanation shall be based on the descriptions set out under Part A. Where relevant, margins of safety shall be assessed and discussed.

There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.

Possible interactions of the substances contained in the cosmetic product shall be assessed.

The consideration and non-consideration of the different toxicological profiles shall be duly justified.

Impacts of the stability on the safety of the cosmetic product shall be duly considered.

  1. Assessor’s credentials and approval of part B

Name and address of the safety assessor.

Proof of qualification of safety assessor.

Date and signature of safety assessor.

 

Prohibited substances

At the end of the document there is a huge list of substances prohibited in cosmetic products. Some of the most obvious are: antibiotics, oestrogens, anti-androgens of steroidal structure, cells or tissues of human origin and asbestos. This long list mostly states many compounds and even their allowed and not allowed levels of impurities.

There is also a list of allowed colorants, preservatives and UV-filters as well as their maximum concentration. For example: “All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning ‘contains formaldehyde’ where the concentration of formaldehyde in the finished product exceeds 0,05 %.”

 

This post contains information directly taken or quoted from the REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL.

 

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