{"id":5688,"date":"2016-12-30T08:15:40","date_gmt":"2016-12-30T14:15:40","guid":{"rendered":"https:\/\/www.ulprospector.com\/knowledge\/?p=5688"},"modified":"2017-02-23T11:08:52","modified_gmt":"2017-02-23T17:08:52","slug":"pcc-eu-regulation-packaging-new-cosmetic-ingredient","status":"publish","type":"post","link":"https:\/\/ulprospector.ul.com\/5688\/pcc-eu-regulation-packaging-new-cosmetic-ingredient\/","title":{"rendered":"EU Regulation: Packaging is a new \u201ccosmetic ingredient\u201d"},"content":{"rendered":"
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Copyright: stylephotographs \/ 123RF Stock Photo<\/a><\/figcaption><\/figure>\n

The main aim of Regulation 1223\/2009<\/a> is to assure the consumer that the product he or she uses is safe. Safety Assessors have to be very careful when validating each cosmetic ingredient, its toxicological profile and traces, or additives it may contain. But the role of the packaging in this process is very often underestimated.<\/p>\n

The requirement for the packaging characteristics is clearly indicated in the Annex I to Regulation 1223\/2009. The information about the packaging material must be presented and evaluated in Safety Assessment:<\/p>\n

4. Impurities, traces, information about the packaging material
\nThe purity of the substances and mixtures.
\nIn the case of traces of prohibited substances, evidence for their technical unavoidability.
\nThe relevant characteristics of packaging material, in particular purity and stability.\u201d<\/p><\/blockquote>\n

One of the general ways to test the stability of the packaging is to test its interaction with finished product under some conditions. But, in this way, the compatibility is evaluated on the basis of organoleptic and standard physical-chemical characteristics, which is not enough.<\/p>\n

Packaging material<\/a> and the substances it contains (e.g. impurities, traces and additives) may not only impact the stability of the cosmetic product, but directly affect its safety. Some substances can migrate from the packaging to the formulation and vice versa, which can lead to the instability of both. In this manner, the packaging starts to \u201cinteract\u201d with cosmetic ingredients, becoming a new \u201cingredient.\u201d<\/p>\n

In reality, packaging material is a \u201cpool of ingredients\u201d: it contains not only polymers, but traces of monomers, catalysts, colorants, UV filters, etc. Moreover, some unavoidable substances may be added into the final packaging, during the processing of polymer material. Considering all these factors, it is starting to be very difficult for the Safety Assessor to examine all the aspects and data.<\/p>\n

With its Implemented Decision on Guidelines on Annex I to Regulation\u00a01223\/2009<\/a>, the European Commission laid down some explanation of how Safety Assessors can manage this problem. Thus, the reference on Regulation 1935\/2004<\/a> was proposed to leverage similar formulation\/packaging combinations already on the market. From this view, the information about food\/packaging interaction may be taken into consideration:<\/p>\n

Materials that have been developed for food packaging have often already been tested, so relevant information on stability and migration may be available. Additional testing may not be required.\u201d<\/p><\/blockquote>\n

Nevertheless, this approach has proven not to be the easiest one. For the precise analysis, the Safety Assessor has to be in possession of the data on all the substances in the packaging material, as well as their impurities, additives and percentage content; information about possible migration and reactivity; the toxicological profile of non-cosmetic ingredients, etc. It makes the evaluation extremely complicated. The difficulties increase even more, because the information about composition is usually confidential.<\/p>\n

In February 2016, the Italian Institute of Packaging<\/a> presented Guidelines which have established some criteria for safety evaluation of cosmetic packaging materials. Afterwards, a collaboration between packaging manufacturers, cosmetic associations and packaging associations resulted in draft EU Guidance detailing information exchange along with the value chain.<\/p>\n

The guidance document proposed a unified approach to clarify and facilitate the exchange of information within the value chain. After a trial period of seven months, which has involved nearly 100 companies, this approach proved to be very useful, thanks to cooperation from both packaging manufacturers and Safety Assessors.<\/p>\n

Nevertheless, this approach has proven not to be the easiest one. For the precise analysis, the Safety Assessor has to be in possession of the data on all the substances in the packaging material, as well as their impurities, additives and percentage content; information about possible migration and reactivity; the toxicological profile of non-cosmetic ingredients, etc. It makes the evaluation extremely complicated. The difficulties increase even more, because the information about composition is usually confidential.<\/p>\n

In February 2016, the Italian Institute of Packaging presented Guidelines which have established some criteria for safety evaluation of cosmetic packaging materials. Afterwards, a collaboration between packaging manufacturers, cosmetic associations and packaging associations resulted in draft EU Guidance detailing information exchange along with the value chain.<\/p>\n

The guidance document proposed a unified approach to clarify and facilitate the exchange of information within the value chain. After a trial period of seven months, which has involved nearly 100 companies, this approach proved to be very useful, thanks to cooperation from both packaging manufacturers and Safety Assessors.<\/p>\n

Looking for packaging options for your personal care formulations?<\/h3>\n

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Safety Assessments with full information on packaging still require time. The strong collaboration between cosmetic associations and packaging manufacturers is a key component, allowing access to important information for high quality Safety Assessments and, thus, safer cosmetic products.<\/p>\n

Additional reading:<\/h4>\n