Guide to EU packaging requirements

We have developed this guide to the EU legal requirements for substances in packaging. It covers requirements in general as well as the requirements of packaging for food contact materials, medicinal products, cosmetics and recycled materials.

In the guide you will find links to the relevant regulations.

Helle Buchardt Boyd

Tel.: +45 4516 9097
hbb@remove-this.dhigroup.remove-this.com

Types of packaging

Use the guide to check whether your packaging complies with the regulatory requirements. Start by selecting the purpose of your packaging as the regulatory requirements depend on whether the packaging is to be used for

Packaging in general

Above all, the EU requirements for packaging materials are intended to prevent impact on the environment, to reduce waste and to increase reuse and recycling of materials.

The maximum concentration of lead, cadmium, mercury and hexavalent chromium is 100 ppm altogether (based on weight).

EU Directive on packaging and packaging waste

Recycled materials

The use of recycled materials in new packaging is regulated by the REACH Regulation.

Waste defined by the European Waste Legislation is exempt from the REACH Regulation, but products made of recycled waste are not. REACH applies to any substance, mixture or item made from recycled waste that no longer fulfils the waste criteria.

It is not a requirement to register substances already registered and developed through a recycling process.

Remember to check if a recycled product contains substances from the REACH Candidate List of substances of very high concern (SVHC), the list of substances restricted under REACH, or the Authorisation List.

Food contact materials regulation

For an overview of the requirements of food contact materials (FCMs) in the EU:

EU Food Contact Materials Regulation

Plastic materials

The EU Regulation on plastics includes a list of authorised substances that may be used in plastic materials for food contact.

Note that the specific restrictions do not include non-intentionally added substances (NIAS), colouring agents or polymerisation processing aids.

EU Regulation on plastic materials

Recycled plastic materials

Raw materials used for recycling must meet the requirements of Regulation 10/2011, and processes for manufacturing recycled plastic must be approved.

It is the European Commission that approves technologies for the manufacture of recycled plastics following based on assessments by the European Food Safety Authority (EFSA). The European Commission will establish a register of processes that have been assessed and found acceptable in an annex to Regulation 1616/2022.

The rules apply also to imported recycled plastic placed on the EU market, including plastic from recycling installations located outside of the EU.

EU Regulation on recycled plastic materials

Current and upcoming EU rules on plastic recycling

Epoxy-treated materials

Epoxy-treated materials such as the inside surface area of tins and cans must not release BADGE and certain derivates of BADGE, and they must not be made of BDFGE or NOGE. This is stipulated in the EU Regulation on restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food from 2005.

EU Regulation on epoxy derivates

Surface-treated materials must not release bisphenol A (BPA) in amounts exceeding 0.05 mg/kg food, and BPA must not migrate at all from materials containing food specifically targeted at children.

EU Regulation on BPA

Metal, paper, cork, printing inks and adhesives

No specific rules exist regulating these materials for food contact. Materials must still comply with the basic requirements and not release substances to food in unacceptable levels. We can help you if you need to establish acceptable levels.

For metals, however, you can refer to the metals and alloys guide from the Council of Europe.

Metals and alloys used in food contact materials

Regenerated cellulose film

Foil made of regenerated cellulose film intended to come into contact with foodstuffs must only be made from substances included on the list of authorised substances in the EU Regulation.

EU Regulation on regenerated cellulose

Ceramics, enamel and glass

There is no common regulation in the EU.

In Denmark, ceramics, enamelled objects or glass objects must not release levels of lead or cadmium higher than what is stipulated in the Danish statutory order on food contact materials.

Danish statutory order (only available in Danish)

Cosmetics packaging

The EU Regulation on cosmetics states that cosmetics packaging should be produced in such a way that it is distinguishable from food packaging and does not imperil the health or safety of users.

Traces of prohibited substances from the packaging are allowed in the cosmetic product if it is technically unavoidable and does not endanger users. We can help you to assess potential hazardous substances.

EU Regulation on cosmetic products

Packaging for medicinal products

Under existing laws packaging for medicinal products must be of a satisfactory quality. The national competent authorities can establish specific requirements for the quality of a packaging, for instance in a pharmacopoeia.

The European Medicines Agency (EMA) has a Guideline on Plastic Immediate Packaging Materials.

EMA Guideline on Plastic Immediate Packaging Materials