Importing cosmetics from outside the eu

Before sourcing a finished cosmetic product in Asia or on the American continent, you should consider what legal bases and requirements exist when placing those cosmetics on the European market. The EU Cosmetics Regulation 1223/2009 applies to cosmetic products in the EU, but national regulations may still apply. For example, in Germany the regulation on packaging¹ and other special regulations such as for the justification of claims used in relation to cosmetic products², aerosol packaging³ and further applications. You can find an overview of the legal framework in Germany for example on the website of the Federal Office for Consumer Protection and Food Safety⁴.

Responsible person

In principle, one should also know that the so-called responsible person is not only indicated on the cosmetic packaging, he or she also has obligations (such as safety of the product, GMP, safety assessment, PID, notification etc.). Every paid  and free supply of a cosmetic product for distribution, consumption or use on the community market in the context of a commercial activity, even promotional gifts at trade fairs, is considered to be placing the product on the market within the meaning of the cosmetics regulation. The full list of responsibilities can be found in Article 5 of the Cosmetics Regulation. A responsible person, by definition, is a legal or natural person within the European Community who is responsible for placing the cosmetic product on the market. This can also be a community-based manufacturer or importer. The responsible person must comply with a notification requirement before import. That means there are legal issues to be clarified and dealt with:

Ten essential points

These points must be considered before and during before the importation of cosmetic products: 

• Is it really a cosmetic product? Cosmetics are, by definition “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” (Article 2 Regulation 1223/2009).
• The responsible person must have a registered office in the EU. The responsible person must ensure that the required obligations of the Cosmetics Regulatiosn are complied with (Articles 4 and 5 Regulation 1223/2009).
• The product must be reported (notified) to the EU’s CPNP portal. Historically, these are reports that used to be made to the national poison information centres and which are now reported to the EU uniformly on the EU portal. The national reports in the respective member states are therefore no longer required (Article 13 of Regulation 1223/2009).
• A product information file (PIF) must be kept. This product information file contains all the information about the cosmetic product, including the formulation, information on the manufacturing process of the product, raw material data and its impurities, packaging data, data on stability, microbiology and shelf life, data regarding claims, animal test data, GMP evidence and, of particular importance, the safety assessment according to Appendix 1 of the EU Cosmetics Regulation (Article 11 of Regulation 1223/2009).
• Labelling of the product. There aremandatory requirements of the labelling, such as name and purpose, nominal content, list of ingredients, shelf life, batch, and the address of the responsible person in the EU. It is also important that statements about the product be made in the national language of the respective country. Certain products, such as aerosols, hair colour and sunscreen, require additional notices and warnings (Article 19 of Regulation 1223/2009).
• The reporting obligation to the responsible authority is another point. A notification must be made to the responsible authority that cosmetic products are to be imported. The responsible authorities can be found under the respective surveillance authorities for cosmetic products5.

• The topic of advertising messages. You should always approach it with care and consider beforehand whether you should avoid implicit advertising. For example, statements such as: “My product is allergen-free”, “My product is vegan”, ... can I prove it? General statements like “it is well known” or “all others do the same” are not helpful. Just because competitors make such statements does not make the actual statement more legal (Article 20 of Regulation 1223/2009 and Regulation 655/2013).
• Animal testing. Unfortunately, there is still the false impression that in the EU cosmetic products are tested on animals. According to the EU Cosmetics Regulation, this is prohibited, both with the finished product and with the raw materials used. This must also be proven. The most important thing here is that animal testing with cosmetics is prohibited in the EU, but not in other countries, such as in Asia. It can be therefore very difficult to prove that animal tests have not been carried out on the cosmetic product that one would like to put on the market in the EU (Article 18 of Regulation 1223/2009).
• What is GMP (Good Manufacturing Practice)? Good manufacturing practice means guidelines for quality assurance of the production processes and environment in the production of cosmetics. A GMP-compliant quality management system serves to ensure product quality and to meet the requirements of the health authorities that are binding for marketing. I don’t produce, do I really have to pay attention to something? The answer is yes. However, it will be difficult to check this. Can you have a look on site? You can certainly do that, but do you have the option of doing an audit or checking a quality assurance system? Therefore, in addition to the verifiability of animal experiments, this is also a very difficult point in order to guarantee GMP compliance (Article 8 of Regulation 1223/2009).
• Customs: the customs authorities support the authorities in consumer protection. The purpose of customs is to ensure that all products imported into the EU meet the same requirements as products manufactured here. When importing, customs offices pay more attention to whether the requirements of the Cosmetics Regulation are met. Is a responsible person in Europe indicated on the label, and is the label in the national language? The customs office also involves local responsible authorities, and then decides whether the product can be imported or not.

Regardless of the import regulations, one always must keep in mind when importing from third countries that – depending on the value of the goods – import taxes and customs duties may apply. The freight forwarder or parcel service will charge the customs clearance for the shipment. In contrast to buying in a community market, you must expect additional costs that aren not included in the retail price of the dealer.

In summary, many points have to be observed so that the product that you purchase in the non-EU country can be safely sold on the EU market. 

References

¹. FertigpackungsV, http://www.gesetze-im-internet.de/fertigpackv_1981

^2. regulation, 655/2013 https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32013R0655

^3. 13th ProdSV, http://www.gesetze-im-internet.de/gsgv_13/index.html

^4. https://www.bvl.bund.de/DE/Arbeitsbereiche/bund.de/DE/Arbeitsbereiche/03_Verbraucherprodukte/ 03_AntragstellerUnternehmen/02_Kosmetik/ 04_Inhaltsstoffe/bgs_fuerAntragsteller_kosmetik_gesetzlicheRegelung_inhaltsstoffe_node.html

^5. In Germany e.g. here: https://www.bvl.bund.de/Shared-Docs/Downloads/03_Verbraucherprodukte/Kosmetik/kosmetik_behoerden_par3.pdf?__blob=publication-File&v=6