Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Comission consultation, 29 May 2019
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Commission consultation: Migration limits for lead, cadmium and possibly other metals from ceramic and vitreous food contact materials A copy of this consultation document is available on this site (click on image). For more details, see the Commission page at: https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2019-325847_en. Consultation closes: 26 June 2019. |
The following is the introductory 'Context' sectdion from the document:
Context
The European Commission aims to ensure a high level of food safety for consumers. The implementation of the EU’s integrated Food Safety policy is based on solid science and thorough risk assessment and, among others, protects consumers from exposure to hazardous chemicals.
Food contact materials (FCMs) are materials such as plastics, paper, ceramics, glass, metals and alloys that are widely used in everyday life in the form of food packaging, kitchen and tableware, appliances and processing equipment. The chemical constituents of these materials may transfer into food, bringing changes in food safety and quality. In this context, EU legislation on FCM provides that these materials shall neither adversely affect consumer health nor influence the quality of the food, and shall be manufactured under good manufacturing practices. The legislation also empowers the Commission to establish limits on the migration of chemicals from FCM into food.
Kitchen and tableware manufactured from ceramic and vitreous materials (where ‘vitreous materials’ include glass and glass enamels) widely circulate in the internal market, and are often imported. Their manufacture may involve specific metal oxides that are added to obtain desired properties, and for which alternatives are limited. Industry uses lead, barium and aluminium primarily for technical purposes. Lead oxide facilitates processing and appearance; it is used in particular at high percentages in glazing and crystal to lower the melting point. The use of lead oxide is also considered a quality requirement for glass which is protected by EU legislation (Council Directive 69/493/EEC, ‘the crystal Directive’) requires that glass can only be named ‘lead crystal’ when it contains at least 24% of lead oxide). Many other metal oxides are used as colorants for decoration purposes. These oxides are often used in artisanal and traditional techniques to manufacture products that may have a special regional or local cultural value. Note that the mentioned metals may also intentionally be used by producers of mainstream tableware in their production processes but either in smaller amounts or on the outside or may be present as impurities.
Many metals, particularly heavy metals, are known to be dangerous to human health. In recent decades, in response to a growing awareness of the need to control exposure, there has been increasing emphasis on establishing appropriate regulatory measures to control the use of heavy metals in general. Many are considered substances of very high concern under REACH. Lead and its compounds have specifically been restricted in petrol, electrical goods, jewellery, and in consumer articles, and maximum levels in drinking water and food have been specified. As a result, the overall exposure to metals decreased significantly over recent decades, but in 2013 it was found to have reached a steady state at a level still toxicologically relevant.
With respect to food contact materials, since 1984, Directive 84/500/EEC ("the Directive") sets out limits for lead and cadmium transfer from ceramics in order to protect human health. However, in 2009 and 2010 the European Food Safety Authority (EFSA) published new scientific advice on the health effects of lead and cadmium in food. EFSA concluded that exposure to lead can cause negative health effects at any dose and significantly lowered its recommendations for what constitutes a tolerable intake level for cadmium. The observed health effects of lead include developmental neurotoxicity (lower Intelligence Quotient) in developing children, for whom there is no safe exposure level, as well as cardiovascular effects and neurotoxicity in adults. Cadmium exerts toxic effects after long-term exposure on the kidney and bones. EFSA concluded that exposure to lead and cadmium should be significantly reduced, and noted that dietary exposure is the main source of exposure to these heavy metals.
In the light of the new scientific evidence from EFSA, some Member States noted that the existing migration limits for lead and cadmium in the Directive would not provide a sufficient protection of exposure for consumers. Hence, they have requested the Commission to lower them to safe levels in light of the new scientific evidence. The glass and enamel industry furthermore pointed at the need to establish similar legislation for these materials, as their products would in practice already be regulated based on the limits set out in the Directive.
Moreover, similar scientific evidence has become available for the toxicity of several other metals. This makes clear that these metals also migrate from ceramic and vitreous materials in amounts that are potentially hazardous to health. These metals include for instance aluminium, arsenic, barium, cobalt, chromium and nickel. Chromium, in its hexavalent form (CrVI), is considered to be carcinogenic. Other metals with toxic properties, such as arsenic and mercury, may be present as impurities. Some Member States already impose limits on metals other than lead and cadmium (see annex 12 and 13 of the study carried out by the Commission’s Joint Research Centre (JRC) on non-harmonised food contact materials).
Earlier consultations with Member States in 2012 identified knowledge gaps on the actual migration of metals from ceramics and vitreous materials into food as well as on available testing methods required for verification of compliance. In order to address these gaps, the JRC conducted research on the topic, testing approximately 6000 samples provided by industry. This work concluded in 2017 when the JRC noted that robust analytical methods exist and that these are representative for food use.
Data received from the official controls done by some Member States indicate that, for approx. 20% of the tested ceramic and vitreous samples, heavy metals migrate into food at amounts that would cause adverse health effects in view of the new scientific evidence. This data also shows that particularly artisanal and traditional products are concerned, and their products show a higher than average migration of heavy metals into food.
