00:16 --> 01:01
Speaker 1
Hello everyone, Welcome to Assurance in Action podcast, my name is Axelle Wipretz, regulatory affairs specialist, and today, I am with Anne-Sophie Moriceau, pharmacist toxicologist. Today, we are presenting our 2nd episode to discuss about packaging within the cosmetics industry. In the first podcast of this series, we talked about the general requirements to verify safety and compliance of cosmetic packaging. We explained that the Packaging Advisory Document recommended to verify food contact compliance, among others requirements. 10/2011 for plastic materials is the most complete specific regulation for food contact materials, but what about the other types of materials?
01:02--> 02:26
Speaker 2
Indeed Axelle. Food contact material regulations in Europe can seem to be quite complex. Regulation (EC) No 1935/2004 - so called framework regulation - contains the basic requirements applicable to all types of food contact materials. Therefore, all Food Contact Materials intended to be marketed in EU should fulfil the framework regulation requirements, namely article 3:
First, Food Contact Materials should not transfer its constituents to the foodstuffs in quantity which could endanger human health.
Second, Food Contact Materials should not bring unacceptable change in the composition of the foodstuff
Third, Food Contact Materials should not deteriorate the organoleptic characteristics of the foodstuff
In addition, Article 5 and Annex I to Regulation (EU) 1935/2004 list 17 categories for which specific measures may be adopted by the Commission on an EU level. However, to date, only five categories have a harmonized specific measure in place (the non-recycled plastics, the recycled plastics, the regenerated cellulose, the active and intelligent articles and materials, and the ceramics).
02:27--> 02:30
Speaker 1
So how are regulating the non harmonized materials in Europe?
02:31--> 03:05
Speaker 2
In order to prove compliance to 1935/2004/EC for these non-harmonized materials, (such as inks, adhesives, paper and board) national regulations exist for some materials, even if it’s not as legally binding for cosmetic packaging. Then, several guidelines, recommendations or norms from some industrial associations or consortium, such as the FEICA and the Council of Europe for example can be used as reference when assessing safety of materials.
03:06--> 03:48
Speaker 1
That is right, the principle of “Mutual Recognition” applies per Regulation (EC) 764/2008 in Europe, in order to facilitate market access between European countries; but in practice it may not work and it should be used carefully. In addition the national legislations are not easy to access because they are not centralized.
Some of them are available only in the official language of the country which issued it. This can complicate the regulatory assessment, that is why this is important to have a local expert, knowing well each specification of the legislations.
Can you give us some examples of non-harmonized materials please?
03:49--> 04:37
Speaker 2
Sure, let’s start by metals and alloys. These types of materials are often used in cosmetic packaging. There is no regulation for these materials at European level, and therefore it is called a "non-Harmonized" material.
However you have several documents, on which you can refer to in order to comply with framework regulation and prove safety.
First, the DGCCRF MCDA sheet n° 1 Suitability for food contact of metals and alloys intended to come into contact with foodstuffs from France, the Chapter IV for Metals from Packaging and Consumer Articles in the Netherlands and the resolution of council of europe on metals and alloys used in food contact materials and articles.
04:37--> 04:46
Speaker 1
So, you have three different documentations to refer to. What requirements do they list for metals & alloys in contact with food?
04:48--> 06:19
Speaker 2
First, it is important to note that all three references have similar requirements. But, there is important differences. The 3 texts require compositional compliance; so the material needs to be manufactured with authorized substances from the respective positive lists.
These substances possess specific migration limit, as for the 10/2011 plastics regulation for example.
The DGGCRF and EDQM files talk about ‘LLS’ limite de libération spécifique in French and SRL specific release limit, respectively, both meaning specific migration limit.
However, we note some different limit : indeed, the SRL for Iron is 40 mg/kg food in the Council of Europe guidelines, but the SML described in the 10/2011, recommended to be followed by the Warenwet Packaging and Consumer Articles, is 48 mg/kg. In addition, the choice of simulant may be also different depending on the reference: the Warenwet Packaging and Consumer Articles for the Netherlands recommend using food simulants as described in the 10/2011/EC regulation, and the EDQM advise to use two simulants, artificial tap water or citric acid.
06:21--> 06:33
Speaker 1
Thank you for these clarifications. But, how to ensure the compliance to 1935/2004/EC for this non-harmonized material, as we have different texts to reference on?
06:35 --> 07:21
Speaker 2
This will depend about the country where you market your product. In addition this is very important to have a well-documented risk-oriented approach in order to support the compliance. The framework regulation does not impose to provide a Declaration of Compliance for non-harmonized materials, in comparison to the 10/2011 it requires to have DoC for plastics at each steps of the supply chain.
Indeed, Article 16 of 1935/2004 reports that “Appropriate supportive documentation shall be available to demonstrate such compliance. That documentation shall be made available to the competent authorities on demand.”
07:22--> 08:06
Speaker 1
Thank you, Anne-Sophie. To sum up, when we have a non-harmonized materials used for cosmetic purpose, it is important to ask to the supplier to provide appropriate documentation to prove compliance to food contact regulation. The safety assessor should always verify applicability to cosmetic use; for example its needs to be verify the good use of simulants and conditions of testing.
As for the harmonized materials, if one non-authorized substance is present in the material, this leads to non-compliance to Food Contact regulation, but not automatically for cosmetic use. A risk oriented approach may confirm the safety for cosmetic application.
08:06--> 08:22
Speaker 2
Thank you, Axelle, for summary. I think this helps the assessor to have keys for the regulatory compliance of their cosmetic packaging, based on all these guidelines and regulation. thank you for listening and see you soon.
08:23--> 08:24
Speaker 1
Thank you very much. Bye.
