Endocrine Disruptors in Europe

Packaging Information is Something Important in the EU

Overlooked for decades, cosmetic packaging raises more and more questions and BIORIUS observed that the European Commission and the National Authorities are getting gradually interested in this topic.
BIORIUS is keen to adapt itself to the state of art and defend at best the interests of its clients. For that reason, we summarized below the legal aspects that you should consider before purchasing packaging or submitting data to BIORIUS.

Obligations coming from the European Cosmetics Regulation (EC No 1223/2009)

The Cosmetics Regulation requires the cosmetic brand and its EU Responsible Person to collect information about the packaging, namely the container (or primary packaging) in direct contact with the cosmetic product. For years the legislation remained non-prescriptive but regulatory developments appeared on the radar screen (see Explanatory note) and could make the need for this information more critical in the future.

Today the legislation provides that a cosmetic brand should, in view to conduct a proper safety assessment, know partially or totally:

  • The composition of the packaging material (including technicalsubstancessuch as additives) and the suitability for cosmetic products.
  • The technically unavoidable impurities.
  • The barrier properties of the packaging material.
  • The possible migration of substances from the packaging to the cosmetic product and the possible interactions between the packaging and the cosmetic product.

For the time being the decision to investigate these elements is up to the Safety Assessor. However, BIORIUS sees more and more pressure from the Authorities and trade associations to actively review these points.

In practice, it is strongly recommended that a cosmetic brand collects as much information as possible about its packaging and shares this information with BIORIUS. At the minimum, this information must include:

  • The Material Safety Data Sheet of each packaging piece in close contact with the cosmetic formula and the general description of the materials used in this packaging.
  • The Certificate of Analysis of each packaging piece in close contact with the cosmetic formula (with details about lead, cadmium, mercury and hexavalent chromium).
  • In most cases, the compatibility study, performed at the same time as the stability test and showing that the packaging does not deteriorate over time (leakage, aspect).

Other pieces of information are very useful:

  • Statement of ‘food contact compliance’: if the packaging used for a cosmetic is also used for food and complies with Regulation EC No 1935/2004 on food contact materials, thisis a sign that the packaging is safe and appropriate. However, the cosmetic must be representative of the type of food initially intended to this packaging. In case this statement cannot be provided, the packaging supplier should be able to justify this absence of guarantee.
  • Statement of ‘Cosmetic Regulation compliance’: BIORIUS should know if the packaging contains Substances of Very High Concern (SVHC in the sense of the REACH Regulation), substancesin Annex II or III of the Cosmetic Regulation orsubstances classified carcinogenic, mutagenic or toxic for reproduction (CMR).
  • The results of a migration test are considered as a gold standard to prove the safety and compliance of a packaging.

Obligations coming from the Packaging & Packaging Waste Directive (EC No 62/1994)

This directive pertains to environmental protection and several requirements have been enforced to reduce packaging-related pollution. The two main requirements of this legislation are:

  • Concentration levels of heavy metal present in packaging: Member States shall ensure that the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components shall not exceed 100 ppm.
  • Return, collection and recovery of packaging waste: cosmetic brands are responsible for their waste and have to contribute financially to a system for the collection of waste. The main system in the EU is the ‘Green dot’ but other exists (List of national waste management organisms).

Other obligations

Beyond the legal requirements and regulatory developments reported above, cosmetic brands should pay attention to national provisions. Indeed, each EU Member State is allowed to regulate aspects that would not be already regulated at the European level. For instance, the ‘Triman’ logo (see picture) shall be labeled in France on packaging made of recyclable materials. Importers and distributors of a cosmetic brand are responsible for the proper application of these national provisions.

Any questions?


  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.