00:16 --> 00:30
Speaker 1
Hello everyone. My name is Speaker 1, regulatory affairs specialist, and today I am with Anne-Sophie Moriceau, pharmacist toxicologist. Welcome to our special podcast series to discuss about packaging in the cosmetics industry.
00:30 --> 01:09
Speaker 2
Thank you, Axelle. Hello everyone, my name is Anne-Sophie.
In Europe, marketing of cosmetic products is controlled by the regulation 1223/2009/EC. According to this regulation, cosmetic packaging needs to be fully included in the assessment of the cosmetic product. As you may know, compatibility testing needs to be performed with the formula in contact with the packaging in order to verify the stability of the cosmetic product, in real use. Axelle, can you explain exactly what other requirements are listed in the cosmetic regulation for the packaging, please?
01:10 --> 02:06
Speaker 1
Sure. As you know, according to Article three of the regulation, the whole cosmetic product must be sure for human health. The regulation authorizes the presence of substances stemming from the material into the formula subject that the substances are compliant with Article 3 so are safe for human health. The Annex I of the regulation describes the safety assessment to be performed on the cosmetic product, and notably the data necessary for the assessment of packaging, such as the composition of the packaging material, the technically unavoidable impurities, and the possible leachables from the packaging. However, there are few details on how to practically conduct the assessment of the cosmetic packaging. In this context, the Packaging Advisory Document has been published by Cosmetics Europe in 2019. What are the main principles, Anne-Sophie?
02:07 --> 03:35
Speaker 2
First, the main concern is the potential migration of substances from the materials into the formula. Thus, we need to focus on the articles in direct contact with the formula.
Secondly, the physico-chemical characteristics of cosmetic formulation are considered to be close to typical foods. We have of course some exceptions, of course, such as hair colorants, but most of the cosmetic formulations are aqueous or oily, with acidic or normal pH and with a certain level of alcohol. In this context, it is deemed relevant to assume that a packaging acceptable for food contact can also be considered safe for contact with a cosmetic product that has similar physical and chemical characteristics.
However, the Packaging Advisory Document also requires to take into account some substances of concern for cosmetic use, such as CMR substances, so carcinogenic, mutagenic and reprotoxic substances, also skin sensitizer and, of course, the substance prohibited and restricted by the cosmetic regulation.
In addition, it is important to note that all articles needs to be compliant with the 94/62/EC directive relative to heavy metals and the REACH regulation for SVHC levels.
03:35 --> 03:51
Speaker 1
Thank you. And Sophie, the food contact regulation is very important to consider in the regulatory compliance of the cosmetic packaging. As mentioned by the packaging advisory document.
Can you explain more how this regulation works please?
03:52 --> 06:25
Speaker 2
Sure. Indeed, it is very important to understand well the food contact regulation. In Europe, food contact material regulation is guided by the framework legislation No 1935/2004 which requires food contact materials (FCMs) to not transfer chemicals to foodstuffs at levels harmful to human health This is the Article 3. Furthermore, rules for good manufacturing exist (Regulation (EC) No 2023/2006), as well as specific legislation for different material types such as plastics, recycled plastics, ceramics, regenerated cellulose, and active and intelligent materials. But for other material types used in contact with food, the framework legislation applies, and, in addition, specific national legislation may exist. Globally, the regulation, notably the 10/2011/EC relative to plastics, requires two or more levels of compliance: first in terms of composition with a positive list of substances to be used in FCMs, and in terms of testing to assess migration into the formulation. Basically it means that overall and specific migration need to be tested to verify the safety of the material, using appropriate simulants and test conditions, depending on the type of foods and the use of material. The 10/2011 regulation lists several simulants to be used, such as Ethanol 10%, simulant A for aqueous food, also Acetic acid 3% with simulant B applicable for acidic food with low pH, or tenax for dry food. Also, there are specific conditions of testing; for example, to cover long-term storage at ambiant temperature, specific migration needs to be performed for 10 days at 60°C and overall migration for 10 days at 40°C. Thus, if you receive a Declaration of Compliance for Food Contact Materials, it is very important to verify its applicability to the cosmetic product , so the simulants and the conditions of use.
06:26 --> 07:45
Speaker 1
Thus to summarize, there is a lot of regulations and topics to consider when evaluating a cosmetic packaging: the REACH regulation for SVHC, the Heavy metals Directive, the FCM regulations, the CLP for skin sensitiser and CMR, and of course, the 1223/2009 cosmetic regulation for restricted and prohibited substances. All of this requires a clear process internally. My advice is to set up a list of information to be collected from the cosmetic packaging manufacturer in order to comply with cosmetic product regulations, such as, as we said before, composition and regulations compliancy. As a packaging is often composed of several components, those data are needed for each of them.
For possible leachables from the packaging, it can be really helpful to implement a guideline that lists substances that needs to be dosed in your final formula depending on the nature of the material.
In case of recycled plastic, there are other important points to consider. For example, the type of recycling, chemical or physical, may have an impact on the safety of your cosmetic packaging. But that's a subject that could have its own podcast.
07:46 --> 07:51
Speaker 2
And what should be your response when your packaging is not compliant for food contact materials?
07:52 --> 08:19
Speaker 1
First, ask your supplier the reason. The packaging has not been tested. Or is there a real noncompliance? If it has not been tested, it can be possible to launch additional test internally. If it's not compliant, you need to perform a risk oriented approach for the non compliant substances considering the exposure of the cosmetic product. This type of noncompliance always need to be treated as case by case.
08:20 --> 08:56
Speaker 2
Thank you, Axelle, for this lesson in process. This is very interesting. I think this helps the assessor have keys for the regulatory compliance of their cosmetic packaging, based on all these guidelines and regulations.
As we discussed earlier, the difficulty stems mainly from the different food contact materials legislations for non plastic materials. How do we assess these types of materials? We invite you to learn more in a new episode of this podcast series coming soon. Thank you for listening and see you soon.
08:57 --> 08:59
Speaker 1
Thank you. Bye.
