On 11 July 2013, the European Union’s new Cosmetics Regulation (EC 1223/2009) will replace their existing Cosmetics Directive (76/768/EEC). This new rule will now apply to all EU member states. The following points outline the upcoming changes to regulation and how to comply with the measures when exporting cosmetics to EU markets.
1. Product classification
EU law defines a cosmetic product as, “any substance or preparation intended to be placed in contact with the various external parts of the human body 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, and/or correcting body odors, and/or protecting them or keeping them in good condition.”
For more on product classification, refer to the Manual on the Scope of Application of the Cosmetics Directive: http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/manual_borderlines_version50_ en.pdf
2. Ingredient legality
The new Cosmetics Regulation lays out restrictions for special ingredients through a set of Annexes:
- Annex II: substances prohibited in cosmetic products
- Annex III: substances subject to conditions and limitations
- Annex IV: permitted colorants
- Annex V: permitted preservatives
- Annex VI: permitted UV filters
Review the restrictions here: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1976L0768:20100301:en:PDF
3. Product Information File (PIF)
The PIF is required for each product and discloses evidence of compliance to the Competent Authorities for their inspections.
The UK’s guidance document outlines how to prepare a dossier and safety assessment. While it is not binding for other countries, pages 25-31 offer a good indication for a general template: http://www.bis.gov.uk/assets/biscore/consumer-issues/docs/guide-to-cpsr.pdf
Also, under the new Cosmetics Regulation, all safety information must be combined in a cosmetics safety report (CPSR). Each product must have one as part of its PIF. Refer to Annex I, page 21: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF
4. Responsible Person
Only products with a designated Responsible Person can appear on the EU market. The Responsible Person must serve as the primary contact for product compliance and ensure its legal status by maintaining the PIF and safety assessment. Their name and contact info will appear on the product label.
Usually, the Responsible Person is the EU manufacturer, distributor, or importer.
The consultants on this webpage provide “Responsible Person” services: http://export.gov/europeanunion/accessingeumarketsinkeyindustrysectors/eg_eu_044318.asp
5. Labeling
Both the container and packaging must clearly display the following information:
- EU address. The name and address of the Responsible Person as well as where the PIF can be found.
- Nominal content. Metric weight or volume at the time of packaging.
- Durability. Expiration date information based on the nature of the product.
o For products with shelf lives over 30 months, an “open jar” represents the maximum “period after opening,” and the figure below it (e.g. 6 months) is the product’s durability after it has been opened.
o For products with shelf lives under 30 months, the “hour glass” accompanies the date of expiration. The date must indicate the month and year or the day, month, and year, in that order.
- Precautions for use.
- Warnings and conditions.
- Batch number.
- Product use.
- List of ingredients. List in order of descending weight at the time added to the product. Use the nomenclature in the International Nomenclature of Cosmetics Ingredients. Europe’s naming conventions can be found here: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:097:0001:0528:EN:PDF
- Nanomaterials. Indicate the presence of nanomaterials with nano in brackets after the ingredient.
- Country of origin.
Label information must appear in the national or official language of the Member State where the product is sold. However, the ingredients listing must still use International Nomenclature names.
For small packages, consider using a leaflet or card with the product’s labeling information. The container and packaging must reference the leaflet or card with the “open book” symbol. This exemption only applies to warnings, ingredients, and product use information; everything else must appear on the container and packaging.
6. Notification of authorities
Cosmetics do not require the CE mark used for EU products, but notification must still be given to the proper authority. Products require notification before sale through the cosmetics products notification portal (CPNP).
The CPNP electronic system will replace the current mechanisms for notifying Competent Authorities and poison control centres. Notification by the designated Responsible Person will become mandatory in July 2013.
Products already notified at the national level prior to July 2013 must be re-notified to the CPNP.
7. Product claims
The EU has no precise guidelines for product claims (i.e. “organic,” “natural”). They have a general good-faith requirement that, “labeling, marketing, and advertising of cosmetics products, texts, names, trademarks, pictures and figurative or other signs cannot be used to imply that these products have characteristics or functions which they do not have.”
If a product makes any such claim, the PIF must have information to support that claim.
8. Animal testing
The EU has prohibited animal testing since 2009. An exception was made until 11 March 2013, but only for products tested for repeated-dose toxicity, reproductive toxicity, and toxicokinetics.
9. Marketing and sales
The EU has rules for internet marketing, internet sales, and direct sales:
- Internet marketing. The e-commerce Directive (2000/31/EC) imposes business requirements explained here: http://ec.europa.eu/internal_market/e-commerce/index_en.htm
- Internet sales. The Directive on Distance Selling to Consumers (97/7/EC, amendments) creates obligations for internet venders. See http://ec.europa.eu/consumers/cons_int/safe_shop/dist_sell/index_en.htm and http://ec.europa.eu/consumers/rights/gen_rights_en.htm
- Direct sales. Specific rules apply for sales involving unsolicited visits. See the Directive on consumer protections in contracts negotiated off business premises (85/577/EEC): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1985:372:0031:0033:EN:PDF
10. Trademark protection
To register a product trademark, apply online through the Office for Harmonization in the International Market (OHIM). For more information on European trademarks: http://oami.europa.eu/ows/rw/pages/CTM/regProcess/regProcess.en.do
More Information
This summary is based on information provided by the U.S. Commercial Service in “Steps to Exporting Cosmetics Products to the European Union,” May 2012. The U.S. Department of Commerce does not claim responsibility for actions taken by readers in response to this information and recommends that readers conduct their own due diligence before entering into business ventures. Email them at Office.BrusselsEC@trade.gov
More information for U.S. suppliers: http://export.gov/europeanunion/accessingeumarketsinkeyindustrysectors/eg_eu_044318.asp
Cosmetics Regulation (1223/2009): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF
European Commission website on cosmetics safety: http://ec.europa.eu/consumers/sectors/cosmetics/index_en.htm
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