Friday 5 August 2005
Phthalates are a group of chemicals called phthalic acid diesters. They have a variety of industrial uses and are found in lubricating oils and a wide range of household and consumer goods. In food packaging, phthalate use is limited, mainly to the manufacture of materials such as adhesives and some printing inks.
Phthalates are also a medium that carries other substances that perfume cosmetics. They are used in children’s toys, intravenous blood bags and other medical equipment, some paints and inks and vinyl flooring.
Phthalates take a long time to degrade, or break down, in the environment. This means that they may be found at low levels in some foods.
In animal studies, phthalates have been found to affect the liver, but this is not thought to be a risk for humans at the levels of phthalates that we might consume in food.
In recent years, there also has been some concern that phthalates may have a harmful effect on human reproductive development, because they have been reported to be endocrine disrupters.
Endocrine disrupters are substances that have the potential to interact with hormone systems.
Particular concern has focused on the sex hormones, the female oestrogens and male androgens, because of their important roles in the development of the reproductive system.
Although there is evidence that some wildlife species have been affected by coming into contact with endocrine disrupters, there is still no conclusive evidence of a link between harmful effects on human reproductive health and exposure to these chemicals.
The Agency is aware of the concerns about the potential toxic effects of phthalates. A large programme of research and surveillance by the Agency monitors the safety of substances in food contact materials that might be harmful to human health.
The European Commission’s Scientific Committee on Food (now the European Food Safety Authority) has set limits for the safe use of phthalates in food contact materials and these are made legally binding by the European Commission’s Directives that are fully enacted in UK food law.
The European Food Safety Authority reviews all the scientific data in order to set a tolerable daily intake. This is an estimate of the amount of a substance in food or drinking water that can be consumed daily by people over a lifetime without any appreciable risk to health.
Once a tolerable daily intake has been set by EFSA, the European Commission converts this into a specific migration limit into food. This migration limit is the basis for legislative proposals that are agreed with Member States and made into national laws. Migration limits are used to assess the safety of amounts of a substance that might be found to have migrated into foodstuffs during, for example, the Agency's routine monitoring of foodstuffs on sale to UK consumers.
Food Contact Materials Unit
Food Standards Agency
London WC2B 6NH
Tel: 020 7276 8399
Fax: 020 7276 8514