On December 22, 2009, the Official Journal of the European Union published new regulations revising the existing regulations governing the marketing of cosmetics. The new Regulation 1223/2009 replaced European Commission Directive 76/768/EEC, which governed cosmetics. This directive had been amended 55 times, and the European Court of Justice had issued numerous rulings on its interpretation.
The new regulations are a general code applicable to all member states, designed to simplify regulatory procedures and related terminology, and to reduce ambiguity that arose when the original directives were implemented separately in the 27 member states.
Regulation No. 1223/2009 applies only to cosmetics; medical or biological pesticide products are not subject to its regulation. According to this regulation, "cosmetics" refers to any substance or mixture used on the external parts of the human body for cleansing, altering appearance, or protection, including cosmetic products, soaps, bath preparations (bath salts, bath foams, bath oils, and bath gels), perfumes, depilatories, deodorants, hair care products (shampoos, volumizing powders, hair conditioners, hair creams, and hair styling products), creams, lotions, face masks, primers, shaving products, lipsticks, and toothpaste, etc.
One of the goals of the new regulations is to ensure the safety of cosmetics, and therefore, product traceability is of paramount importance. The new regulations stipulate that cosmetics must designate a legal entity or natural person within the EU as the responsible party before they can be marketed. The new regulations clearly define the responsibilities and obligations of the responsible party, the responsibilities and obligations of the distributor, and the distributor's role in the supply chain. They also clearly explain and expand the scope of the responsible party's duties, and require that product-related information be retained for 10 years after the last batch of cosmetics is marketed.
The new regulations implement several revisions to improve cosmetic safety, including the following:
The European Commission will introduce a safety assessment process for all products containing nanotechnology materials, allowing authorities to impose bans on products once a threat to human health is determined. All product ingredients in nanomaterial form must be clearly listed on the label. The Commission will periodically review regulations governing nanomaterials in response to technological advancements.
l The use of substances listed as carcinogenic, mutagenic, or reproductively harmful (CMRs) is prohibited.
l Restrictions on the use of various other substances. In addition to substances listed in the regulations, all other prohibited substances, restricted substances, dyes, preservatives, and ultraviolet filters are strictly prohibited.
Unintentionally added trace amounts of prohibited substances are permitted if they originate from impurities in natural or artificial ingredients, during production, storage, or migration from packaging, and are technically unavoidable, and comply with safety regulations.
Regarding labeling, imported cosmetics must indicate their country of origin, and all cosmetic ingredients using nanotechnology must be listed on the ingredient list on the label. The ingredient name must also be indicated with "nano" in parentheses.
The European Commission should work with Member States to develop an action plan on claims used in products and guidelines for the fair use of such claims. Misleading claims in advertising and cosmetic labeling are prohibited.
The other provisions of the new regulations summarize previous revisions and emphasize transparency. The following important rules are worth noting:
The ingredients must be listed on the packaging.
The product should be labeled with its expiration date.
Substances that may cause allergic reactions should be clearly listed on the ingredient list so that consumers can pay extra attention.
When consumers select products, they can request product information from the person in charge, including information other than that mentioned above and the label.
The new regulations came into effect on January 11, 2010, and were formally implemented 42 months later (July 11, 2013). The provisions concerning substances harmful to reproductive capacity and the use of nanotechnology came into effect on December 1, 2010, and January 11, 2013, respectively.
The full text of the new cosmetics regulations is available for download in the attached file.
- Reference source: Hong Kong Trade Development Council website, 2010-01-28, Attachment file:l_34220091222en.pdf
