Change in the applicability of CLP RegulationsFood Additives¦labeling and CLP mean food and feed ingredients not in their finished state are no longer exempt
Before the 2nd of July 2012 food and feed ingredients not in their final state were exempt from the Classification Labeling and Packaging Regulations according to the FAQ’s published on the ECHA website. This included food colourings, preservatives and food additives. ECHA and member state bodies have revised the applicability of the CLP Regulations with regard to food and feed ingredients not in their final state and deemed that they are no longer exempt from this regulation. Naturally this news brings with it major changes to the food and feed industries which we will outline this article.
New CLP update to the FAQ’s by ECHA
According to Article 1(5)(e) of CLP, the CLP Regulation does not apply to food and feeding stuffs, as defined in Regulation (EC) No 178/2002 (Food Safety Regulation), and which are in the finished state intended for the final user.
The CLP Regulation does not define the term “final user”, but Regulation (EC) No 178/2002 defines “final consumer” as “the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity”. The same concept can be applied in the context of CLP.
This also applies to the use of a substance or a mixture;
- as a food additive in foodstuffs within the scope of Directive 89/107/EEC,
- as a flavoring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC,
- as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003 or
- in animal nutrition within the scope of Directive 82/471/EEC.
Since Article 1(5)(e) of CLP only refers to food or feeding stuffs in the final state intended for the final user substances or mixtures used in food or feeding stuffs at any stage of production are not exempt from CLP and therefore must be classified, packaged, labelled and notified.
What does this mean for the food/Feed industry?
Now that the interpretation of that Article has been clarified as pertaining only to the substances and mixtures as they are found in the final consumer product the industry will find themselves with the following obligations:
- Manufacturers, importers and downstream users must classify substances and mixtures placed on the market for use in food and feed products in accordance with the criteria set out in Annex I of the CLP Regulation.
- Suppliers must label and package substances and mixtures placed on the market for use in food and feed products in accordance with the CLP Regulation.
- Manufacturers and importers must notify the classification and labelling of hazardous substances, including those which result in mixtures being classified as hazardous, to the C&L inventory at ECHA.
- A safety data sheet (SDS) must be provided for all substances or mixtures classified as hazardous or which meet the criteria for Persistent, Bioaccumulative and Toxic /very Persistent, very Bioaccumulative (PBT/vPvB) to the environment or are included in the Candidate list for Authorisation (SVHC).
- SDS must also be provided where unclassified mixtures contain ≥ 1% of at least 1 hazardous substance (0.2% for gaseous mixtures), or where a mixture contains ≥0.1% of a PBT or vPvB substance or where a substance has a Community workplace exposure limit.
Companies active in the supply and use of food and feed chemicals should:
- Assess their chemical inventory against the requirements of the Regulation to identify any existing non-compliances;
- Plan to address any gaps in compliance, allocating resources and budget, within a realistic timeline;
- Be prepared to explain their compliance strategy in case of inspection by a Competent Authority.
What to do next?
H2 Compliance have expert consultants in the food regulation and CLP fields. One of them has even written this whitepaper to help guide you through this regulation change in more detail and clearly lay out your next steps and new obligations with regard to labeling your chemicals. Download the white paper below.
Alternativily, contact H2 Compliance to organise a free consultation to assess your obligations and make a plan for your products continued compliance and access to the EU market.
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