In the European Union, the contents of cosmetics are regulated by the Cosmetics Regulation (EC) No 1223/2009, which provides the following legal requirements which must be met by the company placing the cosmetic product on the market:
- review cosmetic ingredients and only use compliant ingredients,
- manufacture cosmetics in accordance with GMP,
- perform product safety assessments,
- prepare a compliant product label,
- prepare and maintain a product information file.
However, there is scarce detail on the requirements for the cosmetics packaging. There are only general guidelines:
- the packaging must not contain any of the substances expressly not allowed in the Cosmetics Regulation
- the packaging should be in line with the general safety requirement of Article 3 for the cosmetic product
- the packaging should be safe for human health when used under normal or reasonably foreseeable conditions.
The very useful guideline for safety assessment of cosmetic packaging is an advisory document developed by Cosmetic Europe: INFORMATION EXCHANGE ON COSMETIC PACKAGING MATERIALS ALONG THE VALUE CHAIN IN THE CONTEXT OF THE EU COSMETICS REGULATION EC 1223/2009, 13 June 2019:
“Regarding a potential impact of the packaging on the safety of the cosmetic product, the main concern lies with the potential migration of substances from the packaging into the cosmetic formulation. Depending on the material combination used, such migration may be unavoidable – and indeed, the Cosmetics Regulation acknowledges in Article 17 that: “The non-intended presence of a small quantity of a prohibited substance, stemming from … migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3” (i.e. the requirement for products to be safe). It is therefore important that the cosmetic product safety assessor receives relevant information on the composition and migration behavior of the packaging material in order to be aware if any significant migration occurs and assess whether it would impact the cosmetic formulation safety.
For the following reasons, the information generated under food packaging legislation can in principle also be used for the safety assessment of packaging used for cosmetic products:
- physicochemical similarities between many cosmetic formulations and typical food materials
- manufacturing standards based on Good Manufacturing Practices
- safety assessment of the food packaging based on its composition and potential migration of substances into the food
- similar worst-case ratio of packaging surface to packaging content between food and cosmetics
The Food Contact supply chain has developed a practical approach based on existing legislation which can be adapted for Cosmetic Packaging. The principle has been adopted that, in the majority of cases, if the packaging is safe for a specific type of food, it should also be suitable for cosmetics that have similar physical chemical properties as this food”.
For each component where this is possible, the supplier should therefore state and prove:
- compliance with the general requirements of EU Framework Regulation (EC) No 1935/2004 on food contact materials,
- compliance with the Good Manufacturing Practices (GMP Regulation (EC) No 2023/2006),
- compliance with requirements of EU or national legislation that are applicable for the specific type of food material,
- the types of food (food simulants) for which this statement of compliance is valid. This allows the cosmetic product safety assessor to determine whether the information on food packaging safety is relevant for his specific cosmetic formulation.
To help our customers comply with the above rules – and to make sure their products and packaging are safe to the consumer, our laboratories at J.S. Hamilton offer a range of testing services for cosmetic packaging:
- overall and specific migration into all food simulants
- specific migration of:
- Primary Aromatic Amines (PAAs) and Annex II Metals,
- plasticizers, antioxidants, monomers and other additives,
- Non-Intentionally Added Substances (NIAS) Screenings by methods: GC-MS/FID, LC-QToF-MS, Hedsapace-GC/MS,
- bisphenols A, B, S, F and epoxy resin derivatives BADGE, BFDGE and NOGE in coated materials, plastics and adhesives,
- mineral oils (MOSH/POSH & MOAH),
- sensory analysis acc. DIN 10955, EN 1230-1/-2
- colorfastness acc. EN 646, DIN 53160-1 / -2
- barrier properties against gases: oxygen (OTR), water (VWTR), CO2
Contact our specialists today if you want to schedule testing or organize a sales meeting.
