Which products are ‘cosmetic products’?
‘Cosmetic products’ refers to substances or mixtures that are intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, external genital organs) or with the teeth and 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.
Cosmetic products include:
- creams, emulsions, lotions, gels and oils for the skin;
- face masks;
- bath and shower products;
- deodorants and anti-perspirants;
- hair dyes;
- products for waving, straightening and fixing hair;
- hairdressing, hair cleansing, and hair conditioning products;
- shaving products (creams, foams, aftershaves);
- products for making up and removing make-up;
- products intended for application to the lips;
- dental and oral care products;
- products for nail care and nail polish;
- products for external intimate hygiene;
- sun protection products;
- self-tanning products;
- skin-bleaching products and
- anti-wrinkle products.
Substances or mixtures intended to be ingested, injected or implanted in the human body are not regarded as cosmetic products. These include, for example, tattoos and permanent pigmentation of eyebrows, lash lines or lips.
Assessment of whether a product is cosmetics or not ultimately takes place case by case, and must take account of all the product’s properties. Where it is unclear whether a product is a cosmetic, medicinal or biocidal product, or a medicinal device requiring a CE marking, application should be made to the Finnish Medicines Agency (Fimea) for a classification. This involves measures including the assessment of the product’s composition and the mechanisms of action of its ingredients in relation to its marketing claims and dosage.
If the product is not considered medicinal by Fimea, the National Supervisory Authority for Welfare and Health (Valvira) may decide whether it is a medical device or supply. It is recommended that economic operators establish the classification of their products before placing them on the market.
The new EU Cosmetic Products Regulation (EC) No 1223/2009 was published in the Official Journal of the EU on 22 December 2009. It entered into force on 11 January 2010 and has mainly been applied from 11 July 2013 onwards. The Cosmetics Directive (76/768/EEC)
on which previous national cosmetics legislation was based, was repealed at the same time.
The EU Cosmetics Regulation is directly applicable in all Member States. The Regulation aims to harmonise the requirements set for cosmetic products while ensuring a high level of protection for human health.
The implementation of the Regulation will also call for national implementation measures. The Act on Cosmetic Products (492/2013) was passed on 28 June 2013(Press release by the Ministry of Social Affairs and Health).
The Finnish Act contains provisions on the monitoring of the Cosmetics Regulation, competent authorities and consequences, as well as language requirements set for cosmetic product labels and product information files kept in Finland.
Cosmetics legislation applies to cosmetic products intended for both consumer and professional use.
The Cosmetics Regulation specified a long transitional period (11 January 2010 to 10 July 2013) to allow the cosmetic industry time to make their products compliant with the new requirements and meet the new obligations as flexibly as possible (Articles 39 and 40). Article 15 of the Regulation on the use of CMR substances in cosmetic products, as well as the related authorisation procedure, has been applied since 1 December 2010.
A Commission database set in accordance with Article 13 of the Regulation was opened on 11 January 2012. More information about the Cosmetic Product Notification Portal (CPNP) is available on the European Commission website.
Key changes brought about by the Cosmetic Products Regulation (1223/2009)
- Definitions (Article 2): incl. the definitions of ‘manufacturer’, ‘distributor’ and ‘nanomaterial’
- The concept of ‘responsible person’ (Article 4)
- The specification of the obligations of responsible persons and distributors (Articles 5 and 6)
- Provisions improving product traceability: identification within the supply chain and the product information file (Articles 7 and 11)
- Safety assessment: specific provisions concerning the obligation to set up a cosmetic product safety report and the minimum requirements set for the safety report. (Article 10, Annex I)
- Notification of a cosmetic product in the Commission database before the cosmetic product is placed on the market (Article 13)
- notifying the use of nanomaterials to the Commission database (Article 16)
- labelling requirements – all ingredients present in the form of nanomaterials must be clearly indicated in the list of ingredients of cosmetic products (Article 19)
- Product claims (Article 20)
- CMR substances in cosmetic products (Article 15)
- Communication of serious undesirable effects (Article 23)
Cosmetic products made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use (Article 3 of the EU Cosmetics Regulation), taking account, in particular, of the following:
- presentation including conformity with the Directive 87/357/EEC;
- instructions for use and disposal;
and any other indication or information provided by the responsible person defined in Article 4. The responsible person is responsible for the safety of cosmetic product.
Cosmetics legislation restricts the use of certain ingredients. This is based on a scientific risk assessment of the ingredients of cosmetic products, conducted by the Scientific Committee on Consumer Safety (SCCS) of the European Commission (SCCS’s risk assessment and opinions).
The EU Cosmetics Regulation contains a list of substances prohibited in cosmetic products (Annex II). More than 1,000 substances have been prohibited, including most medicinal substances, pesticides and many organic solvents. Substances which are allowed with restrictions are defined in Annex III. In addition, the Cosmetics Regulation has so-called positive lists, meaning a list of substances allowed for only a specific purpose in cosmetics:
- colourants allowed in cosmetic products (Annex IV)
- preservatives allowed in cosmetic products (Annex V)
- UV filters allowed in cosmetic products (Annex VI).
These lists also contain substance-specific restrictions and mandatory warning labelling.
CMR substances in cosmetics
The use of CMR substances in cosmetics is prohibited. CMR substances refer to substances classified for carcinogenicity, germ cell mutagenicity or reproductive toxicity categories 1A, 1B or 2 according to Part 3 of Annex VI of the CLP Regulation (Regulation (EC) No 1272/2008 of the European Parliament and of the Council on the classification, labelling and packaging of substances and mixtures). Classified CMR substances may be used in cosmetic products by way of exception in cases where the conditions laid down in sections 1 and 2 of Article 15 of the Cosmetics Regulation are met. Hazard classes proposed in line with the CLP Regulation are open for public consultation on the website of the European Chemicals Agency. Further information about the CLP Regulation is available from the Tukes REACH, CLP and Biocide Helpdesk and about CRM substances in cosmetics on the website of the European Commission.
The labelling required for a cosmetic product container and outer packaging is specified in Article 19 of the EU Cosmetics Regulation (1223/2009). Labelling deficiencies compromise the safety of the product safety in the same way as, for example, the use of a banned substance.
Labelling requirements are explained in closer detail in Tukes’ summary of the key requirements of the EU Cosmetics Regulation. Labelling is usually required on both the cosmetic product container and the outer packaging. The required labelling must be provided mainly in Finnish and in Swedish (Article 19 of the Cosmetics Regulation and Section 21 of the Finnish Act on Cosmetic Products).
Cosmetic product containers and outer packaging can be labelled with symbols specified in Annex VII of the Cosmetics Regulation to indicate the date of minimum durability and period-after-opening, and to refer to enclosed or attached information.
The date of minimum durability is indicated with an hourglass symbol or the phrase “best used before the end of”:
It is not obligatory to indicate the date of minimum durability if this is more than 30 months. In such cases, the consumer should be informed of the period of time after opening during which the cosmetic product may be used safely. This is done using the following symbol (the time may be indicated in months or years):
The symbol used to refer to information enclosed or attached to the product:
The list of ingredients must be provided on the product container and/or outer packaging. The list must be preceded by the word “ingredients”.
The ingredients must be listed in descending order of weight. This means the ingredient used in the largest quantity by weight must appear first in the list. Ingredients in concentrations of less than 1% may be listed in any order at the end of the list.
As a rule, the International Nomenclature of Cosmetic Ingredients (INCI) must be used in the list of ingredients. Harmonised nomenclature ensures that the ingredients are identified by the same names in every Member State. This makes it easy for consumers to spot any ingredients they have been advised to avoid (for reasons including allergies), regardless of the European country in which they buy cosmetic products.
Annex 3 to the Cosmetics Regulation No 1223/2009 currently lists 26 fragrancethat must be referred to by their INCI name. Other perfumes and aromatic compositions must be referred to by the terms ‘parfum’ or ‘aroma’.
There is no prior approval procedure for cosmetic products before they are placed on the market. The responsibility for the safety of cosmetic products lies with the responsible person (usually the manufacturer or the importer into the EU/EEA) but also with the distributor. The responsible person ensures that the cosmetic products they place on the market comply with statutory requirements. Before a cosmetic product is placed on the market, the responsible person must ensure that the safety of the product in question has been assessed and that a cosmetic product safety report is set up. The Consumer Safety Act (920/2011) lays down a duty to take care (Section 5). The reason economic operators are required to take care is to prevent hazardous situations and accidents (for example, services that use cosmetic products must know the possible safety precautions and follow them).
The responsible persons and distributors must, if necessary, cooperate with the surveillance authority in all efforts to eliminate the risks caused by the cosmetic products they make available on the market. They have the obligation to take the corrective measures necessary to bring a non-compliant product into conformity or to withdraw it from the market or from consumers. If a cosmetic product presents a risk to human health, responsible persons must immediately inform the competent national authority (in Finland: Tukes) of the Member State in which the product information file is readily accessible, giving details of the non-compliance and of the corrective measures taken. This obligation also applies to distributors, who must also inform the responsible person of the cosmetic product and the competent authorities of the Member States in which the distributor hasmade the product available on the market.
Cosmetic products must be manufactured according to good manufacturing practice (Article 8 of the EU Cosmetics Regulation). International guidelines concerning Good Manufacturing Practice (GMP) are available in the standard EN ISO 22716 Cosmetics (reference EUVL 21.4.2011).
The GMP standard is available in Finnish from the Finnish Standards Association SFS. The standard for example gives guidelines for the production, control, storage and delivery of cosmetic products. The standard covers topics such as personnel, premises and equipment, raw materials and packaging materials, production, finished products, quality control, treatment of products that are out of specification, subcontracting, complaints and recalls, internal audit and documentation.
When a cosmetic product is placed on the market, its responsible person must keep a product information file (Article 11 of the Cosmetic Products Regulation). The file must be kept for ten years, starting from the day the last cosmetic product batch was placed on the market. The responsible person must keep the product information file readily accessible in an electronic or other format at their own address, where it must be available to the competent authority of the Member State in which the file is kept.
The file must be updated if necessary and contain the following information:
a) A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
b) Cosmetic product safety report (Article 10(1) of the Cosmetics Regulation);
c) A description of the method of manufacturing and a statement on compliance with the good manufacturing practice referred to in Article 8 of the Cosmetics Regulation;
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.
Requirements provided in Article 11(1–3) of the Cosmetics Regulation also apply to cosmetic products that have been notified under the Directive 76/768/EEC.
‘Undesirable effect’ means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product (Article 2, paragraph 1, point (o) of the Cosmetics Regulation).
‘Serious undesirable effect’ means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death (Article 2, paragraph 1, point (p) of the Cosmetics Regulation).
According to Article 23 of the Cosmetics Regulation, the responsible person or the distributor must notify all serious undesirable effects known to them without delay to the competent authority of the Member State where the serious undesirable effect occurred. In Finland, this SUE (Serious Undesirable Effect) notification should be made to Tukes. Further information about making a notification is availablehere.
The responsible person has to ensure that the cosmetic product safety report contains information about undesirable effects and serious undesirable effects that is kept up to date and available for those performing safety assessments.
In Finland, Tukes and Finnish Customs as competent authorities supervise that cosmetic products are in compliance with the legislation. Tukes supervises products on the Finnish market, while Finnish Customs controls the import of cosmetics from outside the EEA area. Finnish Customs also has the right to perform surveillance on stored cosmetics dispatched from the EEA area (Finnish Customs/surveillance of foods and consumer goods). Cosmetics are subject to risk-based surveillance. The authorities conduct random checks to make sure cosmetic products meet the requirements set for them. Consumer reports about products that may pose a risk are responded to by means of market surveillance measures, such as requesting information from the manufacturer and importer about product composition. Tukes also, for example, monitors notifications concerning cosmetic products received via the RAPEX system. More information about the RAPEX system is available in theRAPEX section of the Tukes website.
Article 13 of the Cosmetics Regulation (EC) No 1223/2009 obliges all actors, mainly the responsible persons but also distributors in certain cases, to notify cosmetic products to the European Commission’s new Cosmetic Product Notification Portal(CPNP) database before placing them on the market.
The notification obligation is specified in closer detail in Article 13, and notifications about nanomaterials in Article 16 of the Cosmetics Regulation. If a cosmetic product contains nanomaterials, these must be notified to the CPNP database, as laid down in Article 16, six months before they are placed on the market.
Further information about the CPNP database is also available on the Commission website that also contains database user manuals for notifications specified in Article 13 and notifications about cosmetic products containing nanomaterials specified in Article 16.
- Cosmetic Product Notification Portal (CPNP)
- Cosmetic Products Notification Portal (CPNP) Manuals on EU-languages
- FAQ On the last bullet there is a question form by which you can send a question to the comission.
- The CPNP module for the notification of products containing nanomaterials
- Regulation on cosmetic products (EC) No 1223/2009 (consolidated version 25.12.2017)
- Commission Regulation (EU) No 344/2013 amending Annexes II, III and VI Commission Regulation (EU) No 483/2013 amending Annex III
- Commission Regulation (EU) No 658/2013 amending Annexes II and III
- Commission Regulation (EU) No 1197/2013 amending Annex III
- Commission Regulation (EU) No 358/2014 amending Annexes II and V
- Commission Regulation (EU) No 866/2014 amending Annexes II, V and VI
- Commission Regulation (EU) No 1003/2014 amending Annex V
- Commission Regulation (EU) No 1004/2014 amending Annex V to Regulation on cosmetics products
- Comission Regulation (EU) 2015/1190 amending Annex III
- Comission Regulation (EU) 2015/1298 amending Annexes II and IV
- Comission Regulation (EU) 2016/314 amending Annex III
- Comission Regulation (EU) 2016/621 amending Annex VI
- Comission Regulation (EU) 2016/622 amending Annex III
- Comission Regulation (EU) 2016/1120 amending Annex IV
- Comission Regulation (EU) 2016/1121 amending Annex V
- Comission Regulation (EU) 2016/1143 amending Annex VI
- Comission Regulation (EU) 2016/1198 amending Annex V
- Comission Regulation (EU) 2017/237 amending Annex III
- Comission Regulation (EU) 2017/238 amending Annex VI
- Comission Regulation (EU) 2017/1224 amending Annex V
- Comission Regulation (EU) 2017/1410 amending Annexes II and III
- Comission Regulation (EU) 2017/1413 amending Annex IV
- Comission Regulation (EU) 2017/2228 amending Annex III
- Directive 76/768/EEC on cosmetic products (repealed)
Claims used to cosmetic products
- Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products
- Guidelines to Commission Regulation (EU) No 655/2013
Cosmetic products safety report
- Commission Implementing Decision (2013/674/EU) on Guidelines on Annex I to Regulation on cosmetic products
- The SCCS’s notes of guidance for the testing of cosmetic substances and their safety evaluation, 8th revision SCCS/1501/12
CMR-substances (substances classified as carcinogenic, mutagenic or toxic for reproduction)
- CLP-regulation (EC) No 1272/2008
- European Comission: Rules for use of CMR-substances in cosmetic products
- European Chemicals Agency (ECHA): Harmonised classification current consultation
- European Chemicals Agency: Harmonised classification and labelling
Other related links to cosmetic products
- European Comission: Cosmetics
- European Comission: Nanomaterials in cosmetics
- CosIng, the European Commission database
- Comission recommendation 2006/647/EY on the efficacy of sunscreen products and the claims
- SFS-EN ISO 22716 Guidelines on Good Manufacturing Practices (GMP)
- Cosmetics Europe
- Animal testing
- Questions and Answers on cosmetics and REACH-regulation
Continue at: http://www.tukes.fi/en/Branches/Chemicals-biocides-plant-protection-products/Industrial-and-consumer-chemicals/Cosmetics/
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