REGULATIONS
cosmetic products. The International Organization for Standardization (ISO) quality standard: ISO 22716:2007 is specific to GMP in relation to cosmetic products.10
This ISO standard gives
guidelines for the production, control, storage and shipment of cosmetic products.
The introduction of this requirement will definitely impact some individuals and companies in the industry. It will be particularly significant to smaller ‘cottage industry’ companies and brands that may not currently be set-up to meet the requirements as set out in Article 8 of the Regulation.
Article 8
Good manufacturing practice 1 The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.
2 Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
Raw materials
The existing Cosmetics Directive did of course go through several amendment stages with many changes specifically in relation to raw materials so it will be no surprise that the vast majority of points in the new Regulation simply carry forward the latest points from that Directive in its final form. However the new Regulation does include several additions relating to raw materials when compared to the existing Cosmetic Directive. There is revised wording regarding substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) and when they can or cannot be used. Article 15 provides clear guidance in relation to CMR substances.11
This
clarification proves to be a useful and important addition as it considers the potential use of some CMR substances in situations of carefully considered application, exposure and dose. We are all too aware that in order to understand the true safety of raw materials and products, the full picture in terms of application and exposure is vital. If this approach is used consistently, a lot of the inaccurate scaremongering media reports that have had major impacts on the cosmetic industry (affecting parabens and lanolin – to name a couple) may be easier to control.
The Regulation acknowledges that the use of nanomaterials in cosmetic products
14 PERSONAL CARE April 2012
may increase with the large amount of research and development ongoing in this area. The Regulation defines a nanomaterial as an: insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on a scale from 1 to 100 nm.12 Article 16 of the Regulation provides full instructions relating to the use of nanomaterials in cosmetic products.13 By 11 January 2014, the European Commission intends to make available a catalogue of all nanomaterials used in cosmetic products placed on the market, with the aim of clarifying what it sees as suitable exposure conditions.14
Conclusions
On the face of it, the overriding aim of the new Cosmetic Regulation is to further scrutinise the safety of cosmetic products and put in place the necessary stipulations and procedures to ensure information is readily available. That can only be a positive thing for the industry as a whole and of course for the consumer. Comparing the new Cosmetic Regulation to the existing Cosmetics Directive, the majority of the content is the same, which should be no surprise as the Cosmetics Directive has been through several amendments over the years. The wording of the new Cosmetic Regulation is much clearer across the entire document and removes the ambiguity that surrounded some of the text in the Cosmetic Directive, with various points in the existing document having been open to interpretation. Again, this improved wording is a positive move and will hopefully ensure consistency across all EU member states. The increased requirements in terms of information gathering and record-keeping are step changes and will have an impact on the industry. Companies producing, selling or importing cosmetic products
should start to prepare accordingly to understand all of the requirements (including registration of products on the new central EU CPNP system). The role of the ‘Responsible Person’ (whether in-house or subcontracted) is very clearly defined but also marks a step change with much greater responsibilities both before a cosmetic product is launched and indeed when it is in the marketplace.
The raw material sector has had plenty to cope with legislation-wise in recent years with many factors such as the introduction of REACH. The new Regulation does continue the principles of the Cosmetic Directive with respect to raw materials and the new stipulations seem only to support the sector well and help to define some of the previously ‘grey areas’ (such as nanomaterials).
The wording in the Regulation with regards to the expectations of manufacturers may concern some companies but again is a positive move towards tightening up the practises across the industry to ensure quality and consistency. Ultimately consumers can only benefit from this.
It will be interesting over the coming months between now and July 2013 to see how companies start to put systems in place ready to comply. One thing that is for sure, preparation is key.
PC
References 1 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
2 Art. 3., Regulation (EC) No 1223/2009, 30.11.2009.
3 Art. 10., Regulation (EC) No 1223/2009, 30.11.2009.
4 Annex I., Regulation (EC) No 1223/2009, 30.11.2009.
5 Art. 11., Regulation (EC) No 1223/2009, 30.11.2009.
6 Art. 13., Regulation (EC) No 1223/2009, 30.11.2009.
7
http://ec.europa.eu/consumers/sectors/ cosmetics/files/doc/cos_transitional_ provisions_en.pdf
8 Art. 5 point 2., Regulation (EC) No 1223/2009, 30.11.2009.
9
http://ec.europa.eu/consumers/sectors/ cosmetics/files/pdf/cpnp_user_manual_en.pdf
10 The International Organization for Standardization, Quality Standard ISO 22716:2007.
http://www.iso.org.
11 Art. 15., Regulation (EC) No 1223/2009, 30.11.2009.
12 Art. 2 point (k)., Regulation (EC) No 1223/2009, 30.11.2009.
13 Art. 16., Regulation (EC) No 1223/2009, 30.11.2009.
14 Art. 16 point 10 (a)., Regulation (EC) No 1223/2009, 30.11.2009.
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