The European Union’s Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (“REACH Regulation”) requires the European Chemicals Agency (“ECHA”) to identify so-called Substances of Very High Concern (“SVHCs”) and to list them in the Candidate List of Substances of Very High Concern (“Candidate List”).1  SVHCs listed in the Candidate List are subject to stringent information and notification requirements that apply to the substances on their own as well as to products containing them. For example, starting as of 1 June 2011, manufacturers and importers of objects, such as textiles, paper, electronic components (so-called “articles”), containing a Candidate List substance in concentrations of more than 0,1% may be required to submit a notification to the ECHA. Similarly, since October 2008, as soon as a substance is listed in the Candidate List, suppliers of articles containing such substance in concentrations of more than 0,1% are required to inform their customers. Suppliers of Candidate List substances and mixtures containing them may also be required to supply safety data sheets to their customers.

SVHCs may include Category 1 and 2 carcinogens, mutagens and toxic to reproduction substances (“CMRs”); persistent, bioaccumulative and toxic substances (“PBTs”); very persistent and very bioaccumulative substances (“vPvBs”); and substances raising an equivalent level of concern.

The criteria are given in article 57 of the REACH Regulation. A substance may be proposed as an SVHC if it meets one or more of the following criteria:

  • it is carcinogenic;
  • it is mutagenic;
  • it is toxic for reproduction;
  • it is persistent, bioaccumulative and toxic according to the criteria set out in Annex XIII to the REACH Regulation(PBT substances);
  • there is “scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern”; such substances are identified on a case-by-case basis.

Benefits

To be useful, packaging must safely protect and deliver a product from the manufacturer to the consumer. Packaging must meet regulatory requirements—for example, pharmaceutical and drug packaging is tightly regulated; so is any packaging in contact with food. Packaging must protect the contents from damage and leaking. And it must meet expectations regarding aesthetics, merchandising, cost, ease of use, ease of opening and resealing, weight, fuel savings, greenhouse gas emissions, and so on. The right plastic packaging can deliver on these expectations, whether protecting fragile medical equipment or fresh foods

Plastics help bring home more product with less packaging. Plastic packaging in general is lightweight and strong—different plastics can be molded, extruded, cast and blown into seemingly limitless shapes and films or foams. This resourcefulness often delivers while using minimal resources, creating less waste, consuming fewer resources and creating fewer CO2 emissions than alternative materials. Plastics make packaging more efficient, which ultimately conserves resources.

Modern plastic food packaging—such as heat-sealed plastic pouches and wraps—helps keep food fresh and protects it from contamination. Packaging experts estimate that each pound of plastic packaging can reduce food waste by up to 1.7 pounds

Use of SVHCs in food contact materials and articles

This will include substances that are considered as SVHCs. As was mentioned in the REACH section, the assignment of the SVHC designation to a substance is one that comes about from a study of the hazard status of a substance. This is in contrast to the assessment of a substance as a component of food contact materials which will set a migration limit below which the transfer is considered safe and renders the food contact material to be inert. In the case of monomers or additives listed as SVHCs, it is important to note that if such substances are approved in food contact regulations a maximum permitted level in the final article will have been set. So SVHC substances that are authorized by the regulation (EU) n° 10/2011 can continue to be used to prepare Food Contact Materials only if the final materials meet the requirements of this regulation and other legislations applicable to them (e.g. regulation on waste).

Environmental concerns

Even though food contact plastics have a robust safety assessment for consumer use, consideration should be given to the fact that certain food contact materials may give rise to concern because of the use of certain substances that have been placed on the REACH candidate list because of their PBT and vPvB properties. If such substances are below the SVHC declaration limit (see above) of 0.1% w/w in the plastic they can continue to be used but if they do not meet this requirement their presence must be declared down the supply chain in accordance with the requirements of the REACH regulation.