These new cosmetic requirements are released in the form of EU regulations in the 27 EU member states plus Norway, Iceland and Liechtenstein, and implemented as national law, unlike the EU directives which need converting into each domestic version. Regulation (EC) No. 1223/2009 will replace the old cosmetics directive 76/768/EEC and the subsequent 67 amendments.
The new regulation simplifies the cosmetic requirements of EEA, making itself a single law, and eliminate ambiguities that may occur among the member states during the enforcement process. The updated cosmetics notification shall be submitted to a database developed jointly by the European Committee and the European Cosmetics Association (COLIPA) instead of each individual member state. However, companies need to do notification by themselves and preserve relevant documents, rather than have industry associations keep them.
The new law indicates three enforcing time lines for different scope of cosmetics on the EU market:
- At the first stage, the law focused on safety control of cosmetics containing CMR substances. From 1 December 2010, it is prohibited to use CMR 1A/1B/2 substances in cosmetics, though certain CMR 2 substances may be exempted by the EU Scientific Committee of Consumer Safety (SCCS) after assessment. But CMR 1A and 1B that are more hazardous need to meet more stringent standards.
- At the second stage, that is from 11 January 2012, nano materials in cosmetics will be incorporated into the legal regime. In addition to the need to comply with other notification requirements, as to cosmetic products containing nano-materials put on the market before January 11, 2013, companies should notify the Committee by electronic means for approval to use before July 11, 2013.
- At the last stage, all cosmetics should apply to the new regulation since 11 July 2013. Specific industry obligations subject to the new law are shown as below.
Liable persons under the new regulation are now more clearly defined:
- Producers within the EEA;
- Importers who input products into the EEA ;
- Distributors having the following activities within the EEA:
- Use their own names, or trademarks to market the cosmetics;
- Make changes to products that may affect its regulatory compliance (excluding only literal translation);
- People appointed by the manufacturer or importer to be a liable person within the EEA, provided the appointment and the specific agreement shall be in written form.
A Manufacturer within the EEA is the natural liable person unless the manufacturer specifies some other one as an agent.
Good Manufacturing Practices (GMP)
There are unified standards providing the baseline specification for mandatory GMP, but companies can still adopt other standards or systems which at least have the same effect as GMP.
The above standards refer to EN ISO 22716: 2007 Cosmetics – Good Manufacturing Practice (GMP) - Guidelines on Good Manufacturing Practices, which has become universally accepted across the EU since its release in the Official Journal of the European Union. Some member states have converted it to a national standard.
Although it's not mandatory to comply with EN ISO 22716, the unified standards provide a most convenience choice for companies.
Cosmetics Safety Report
The safety assessment document contains two parts, extending the range of data that previous assessment needs to consider, some of which already exist.
Under different exposure approaches, raw materials that have significant ability of absorption and may cause systemic toxicity should be assessed. No Observed Adverse Effect Level (NOAEL) is regarded as the starting point used to calculate the margin of safety (MoS). If there is no such assessment, it’s necessary to provide reasons. Microbiological quality report and test of stability report should be submitted before safety assessors’ final signing of cosmetics safety reports.
According to the current order 76/768/EEC, the products having been notified still need to provide a cosmetics safety report complying with the new regulations.
Part A-cosmetics safety information
1. Quantitative and qualitative assessment of cosmetic ingredients
2. Cosmetics physical / chemical properties and stability
* Including the stability test report
3. The quality of microorganism
* The limit of microorganism
* Effectiveness test report of preservatives
4 Information on impurities, trace substances as well as packaging materials
* The purity of raw materials
* Evidence of technically unavoidable existence of trace prohibited substances
* The specifications of packaging materials, including purity and stability
5. Normal and reasonably foreseeable use
6. Cosmetics exposure
7. Components exposure
8. Components toxicity information
9. Adverse effects and serious adverse reaction
10. Information on cosmetics
* The study conducted on human volunteers
* Other validated risk assessment
Part B-cosmetics safety assessment
1. Assessment conclusions
2. Warnings on labels and introductions for use
4. Qualifications of assessors and confirmation of part B
Product Information File (PIF)
Similar to the current product information package (PIP), PIF consists of a cosmetics safety report and a GMP compliance statement.
According to the current directive 76/768/EEC, products having been notified also need to provide PIF in line with the new regulations.
The liable person is responsible to preserve PIF for 10 years following the last batch of products placed onto the market.
The liable person must notify the committee for every cosmetic product which is already in use through the database.
The committee will convey the above information to the competent authority and poison management center or relevant institutions of every member state.
There’s no need for a separate notification in the country of sale.
The notification content should include:
- Cosmetics category and name for identification
- Country of origin (from where it is imported to EEA)
- Target market (a member state)
- Detailed information of the contact person
- Nano-materials- identification and name (IUPAC), CAS number, EINECS or ELINCS number, generic brand name
- CMR – name (IUPAC) and CAS or EINECS or ELINCS number
- Structural formula (only provided to poison management center or relevant institutions)
- Original labels, and packing photos if possible.
Cosmetics imported into the EEA must be marked with the country of origin.
Shortest term of validity – Phrases indicating shortest valid time such as “best used before the end of…” can be replaced by the new mark-egg timer:
If the validity date of opened cosmetics does not matter (conformed by practice), there is no need to specify it.
“nano” should follow the name of the nano-materials in ingredient list.
Before the placing of products on the market, distributors need to make sure they are in compliance with the following labeling requirements:
- Liable person's name or registered name and address
- Cosmetics batch numbers or other identification information
- Ingredients list
- Derogation of soap, bath balls and other small products
- National regulations on non-pre-packaging or packaging of cosmetics requested by the buyer, or on pre-packaging for immediate sale
It is high time to make preparation for EC No 1223/2009 now that industry has only one full year before the new law takes effect in 2013. Industry can expect a cocktail of tasks on collecting supplementary materials for the new cosmetics safety report. Other compliance duties include GMP auditing/update and so like. All of these are time-consuming. So start right now!
1 EEA includes 27 EU member states as well as Norway, Iceland and Liechtenstein.
2 OJ L 342, 22.12.2009, p. 59
3 CMR 1A/1B/CMR 2 in Part 3 of Annex VI of Regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances and mixtures (preparations).
This news item was sourced with the help of the Chinese Center for Alternative Research & Evaluation.