Cosmetic Products New EU Regulation Published From 11th July 2013 cosmetic products placed on the market within the European Economic Area1 (EEA) will have to comply with the new EU Cosmetic Products Regulation (EC) No 1223/20092. However, some of the new Regulations requirements will apply sooner as highlighted below. These new cosmetic products requirements are published as an EU Regulation which takes effect as national law within each of the 27 EU Member States (here along with Norway, Iceland and Liechtenstein too) without the need for the national implementation necessary with an EU Directive. Regulation (EC) No 1223/2009 replaces the old Cosmetic Products Directive 76/768/EEC and its 67 amendments, to date. The new Regulation simplifies the EEA requirements for cosmetic products into a single law and removing issues arising from differences in the national implementing legislation. Notification of cosmetic products will only have to be made to the central Commission database, being developed by the Commission s three ad hoc groups on the future Cosmetics Notification Portal (CPNP), rather than to each Member State at present. However, each company will become responsible for their own notification, rather than have a trade association take care of it on their behalf. 1st December 2010 CMRs (substances classified as carcinogenic, mutagenic or toxic for reproduction3) The use of substances classified as CMR category 1A, 1B or 2 shall be prohibited. Exemptions may be granted by the EU s Scientific Committee for Consumer Safety (SCCS), with additional stringent criteria having to be met for the more hazardous category 1A and 1B CMRs. 11th January 2013 Nanomaterials Cosmetic products containing nanomaterials that were placed on the market prior to 11th January 2013 shall be notified to the Commission by electronic means before 11 July 2013, in addition to the other notification requirements 1 European Economic Area (EEA) comprises the current 27 European Union Member States, along with Norway, Iceland and Liechtenstein. 2 OJ L 342, 22.12.2009, p. 59, http://eur-lex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2009:342:0059:0209:en:pdf 3 CMR categories 1A, 1B and 2 under Part 3 of Annex VI to the Classification, Labelling and Packaging of Substances and Mixtures Regulation (EC) No 1272/2008, http://eur-lex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2008:353:0001:1355:en:pdf
11th July 2013 All cosmetic products Other requirements Responsible Person The identity of the Responsible Person is now more clearly defined as: Manufacturer within the EEA. Importer into the EEA. Distributor within the EEA who: o Places the cosmetic product on the market under his own name or trademark, or o Modifies a cosmetic product in way that may affect its compliance (but does not include merely translation). A person within the EEA appointed by the manufacturer or importer to act as their Responsible Person. Both the mandate request and agreement of the selected person shall be in writing. A manufacturer within the EEA is deemed to be the Responsible Person, unless they mandate another person to act on their behalf. The Responsible Person will have many further legal obligations under the new requirements, the main points of which are highlighted below. Good manufacturing practice (GMP) A harmonised standard will now provide benchmark criteria for the mandatory good manufacturing practice. However, other standards or systems providing at least an equivalent level of GMP could be used. This standard is expected to be EN ISO 22716:2007 Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices; becoming harmonised when its reference is published in the EU s Official Journal. It has already been transposed as a national standard in several Member States. Good manufacturing practice in compliance with the harmonised EN ISO 22716 will then offer a presumption of conformity to the Regulation s GMP requirements. While compliance with EN ISO 22716 is not mandatory, its harmonised status offers the simplest option.
Cosmetic Product Safety Report Two part safety assessment document, which broadens the range of data previously considered. Some of the additional data will be already be on hand. Consideration is made of each raw material, based on calculations of the margin of safety (MoS) will be required based for all significant toxicological routes of absorption and systemic effects, based on a no observed adverse effects level (NOAEL). The absence of any such considerations shall be duly justified. Microbiological quality and stability test reports will be required before the cosmetic product safety report can be finally signed off by the safety assessor. Required for products already notified under the current Directive 76/768/EEC. Part A Cosmetic Product Safety Information 1. Quantitative and qualitative composition of the cosmetic product 2. Physical/chemical characteristics and stability of the cosmetic product Including stability test reports 3. Microbiological quality Microbiological specifications Preservation challenge test reports 4. Impurities, traces, information about the packaging material Purity of the raw materials Evidence to support the technical unavoidability of traces of prohibited substances Packaging material specifications, including purity and stability 5. Normal and reasonably foreseeable use 6. Exposure to the cosmetic product 7. Exposure to the substances 8. Toxicological profile of the substances 9. Undesirable effects and serious undesirable effects 10. Information on the cosmetic product Studies using human volunteers Other relevant, validated risk assessments Part B Cosmetic Product Safety Assessment 1. 2. 3. 4. Assessment conclusion Labelled warnings and instructions of use Reasoning Assessor s credentials and approval of Part B
Product Information File (PIF) Similar to the current Product Information Package (PIP), and will include the Cosmetic Product Safety Report along with a statement of GMP compliance. Required for products already notified under the current Directive 76/768/EEC. Shall be held by the Responsible Person for ten years after the last batch of the cosmetic product was placed on the market. Notification The Responsible Person will have to notify each cosmetic product to the Commission via a database that is under development. The Commission then makes this information available to the competent authorities and poison centres or similar bodies within each Member State. Separate notifications in each Member State in which the cosmetic product is marketed are no longer required. This notification shall include: o Category of cosmetic product and name(s) by which it is identified o Country of origin (where imported into the EEA) o Member State in which it will be placed on the market o Contact details of a physical person to be contacted if necessary o Nanomaterials identification and name (IUPAC), CAS number, EINECS or ELINCS numbers, non-proprietary name o CMRs name (IUPAC) and CAS or EINECS or ELINCS numbers o Frame formulation (only provided to poison centres or similar bodies) o Original labelling and, where possible, a photograph of the packaging
Nanomaterials A nanomaterial is defined as insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. The very small particle size of nanomaterials may affect their chemical and even toxicological properties compared to larger particles. Hence additional scrutiny is required. Substances used in cosmetic products as nanomaterials include titanium dioxide, zinc oxide, silica, carbon black, iron oxide and alumina. Nanomaterials used as colourants, preservatives or UV-filters (Annexes IV to VI) are exempt from these additional requirements unless expressly specified. Six months prior to being placed on the market, the Responsible Person shall notify use of nanomaterials to the Commission (in addition to the general notification for the cosmetic product). For each nanomaterial the notification shall include: o Identification and name (IUPAC), CAS number, EINECS or ELINCS numbers, nonproprietary name o Specification, including particle sizes, physical and chemical properties o Estimate of the quantity of the nanomaterial placed on the market, per year o Toxicological profile o Safety data for use in the relevant type of cosmetic products o Reasonably foreseeable exposure conditions Where the Commission has safety concerns regarding a nanomaterial it will request an opinion from the EU s Scientific Committee for Consumer Safety (SCCS). A period of 6 months is allowed for the SCCS opinion. However, where necessary further data may be requested from the Responsible Person within a specified time. In which case a new 6 months period for the SCCS opinion begins on receipt of all outstanding data.
Labelling Country of origin will be mandatory for cosmetic products imported into the EEA. Date of minimum durability - the preceding text, best used before the end of (in that order) may be replaced by the new egg timer symbol: Date of minimum durability egg timer symbol Period after opening labelling will not be required where the concept of durability after opening is not relevant. (Confirming current practice). Names of nanomaterials in the list of ingredients shall be followed by (nano), in brackets as shown. Product Claims Common criteria to justify the use of certain claims are to be developed. Distributors Distributors shall verify compliance of the following labelling requirements before making a cosmetic product available on the market: o Name or registered name and address of the Responsible Person. o Batch number or identifying reference for the cosmetic product. o List of ingredients. o Derogations for soap, bath balls and other small products, if applicable. o National rules for cosmetic products not pre-packed, packaged at the point of sale at the purchaser s request or pre-packaged for immediate sale.
Now is the time to start preparing for this new EU cosmetic products legislation. For example, gathering additional data for the new Cosmetic Product Safety Report and auditing/upgrading GMP systems could be time consuming. So the distant 2013 deadline will be upon us very quickly!! Intertek solutions: Intertek s team of experts have a good knowledge of the new Regulation s requirements, assisting you to be ready for 2013. As a global leader in testing, inspection and certification, Intertek s Healthcare and Beauty Product Division has developed a comprehensive set of services including safety and efficacy testing, clinical and user trials with human volunteers, in vitro testing, claim substantiation, GMP training and auditing, chemical and microbiological testing, along with toxicological assessment services, and benchmarking. We enable brands and producers accelerate their international growth, optimizing the quality and safety of their supply chain while reducing overall costs. Should you have any queries on the above information, please e-mail our Health and Beauty Products team at health.beauty@intertek.com