Who on earth would think of putting a toxic chemical in a baby's plastic toy? This may come as a nasty surprise, but some rather dubious chemicals called phthalates have, until fairly recently, been routinely added to many products without a full evaluation of their health effects on children.
Phthalates are clear liquids with little or no smell used in PVC vinyl plastic products to make them soft and flexible. Exposure can occur by skin contact or by children sucking on pacifiers and plastic toys.
DEHP has been used in toys, teething rings, food packaging cling wrap, shower curtains, building materials and medical devices. A phthalate called DBP has been used in adhesives, insect repellents, plumbing pipes, and personal care products such as nail polish, skin moisturisers and deodorants.
At first industry hailed phthalates as compounds which give colour-fast, durable, low-maintenance qualities to toys, baby bottles, paints, cars, vinyl flooring, shower curtains, wallpaper, food containers and medical devices. Then concerned environment and consumer groups showed their disapproval of these pervasive and bio-accumulative substances. Human bodies and breast milk become storage places for these dangerous chemicals.
Some sectors of industry still claimed that there was not enough conclusive evidence of adverse health effects but several responsible companies producing baby toys began removing the chemical from their plastic products.
DEHP and DBP phthalates can trigger cancer and have also been linked to immune suppression and harm to developing reproductive organs. Unborn babies are particularly sensitive to the effects of phthalates.
Women's action groups protested that chemicals which could have negative effects should not be used in products marketed for personal or household use. They complained that they were deprived of the choice to avoid phthalates because manufacturers were leaving them out on product labels.
Women aged 20 to 40 receive the highest exposures and workers in the cosmetics and beauty industry face heightened exposure.
A panel of the US National Toxicology Programme found that infants and children receiving intensive medical treatment using vinyl plastic medical devices could be receiving doses of the chemical DEHP comparable to those that cause harm in laboratory animals. The Centre for Disease Control and Prevention admitted that people were being exposed to relatively high levels of phthalates.
Banned
In 2001 the EU classified DEHP and DBP phthalates as substances toxic to reproduction with a directive on classification and labelling of dangerous substances. The two phthalates were defined as chemicals that are to be regarded as impairing fertility and causing developmental toxicity.
The use of all reproductive toxins in cosmetics while prohibiting carcinogens and mutagens (capable of causing cancer or genetic mutation in humans) has long been prohibited. The relevant directive requires that the composition of a cosmetic product, and any undesirable effects on human health from using the product, must be publicly available to consumers. DEHP and DBP were no longer allowed as an ingredient in children's toys, which are likely to be put in the mouth.
Despite such measures, legislation controlling the use of toxic substances in manufactured products has been rather scattered until Europe decided to review its chemicals policy with a new system called REACH - Registration Evaluation and Authorisation of Chemicals.
Europe's gradual move towards safer chemicals started in 1967. In 1981, after much discussion, companies marketing new chemicals were obliged to provide safety information for new chemicals. But no safety data were required for chemicals already on the market. This system did not work because of lack of safety data on the pre-1981 chemicals and too much complexity surrounding control of the many chemicals that were of high concern, like phthalates.
Discussions began in earnest in 1998 in the hopes of finding a new system and in 2001 the REACH proposal was approved by Council and Parliament approved for drafting of the regulation to go ahead under DG-Environment and DG-Enterprise.
European environmentalists have had some serious concerns about specific loopholes and shortcomings in the draft REACH proposal, which they would like to see addressed. Case law of the European Court of Justice states that protection of public health must take precedence over economic considerations.
On November 17 the European Parliament will be voting on REACH after a two-year Internet consultation with industry. A half-day conference on the impact of the new chemical regulation on SMEs was held last month by the Malta Business Bureau with the support of the British High Commission.
Industry argues that the amounts in use, usually measured in parts per billion, are small.
"Eight hundred and forty thousand parts per billion of phthalate found in a baby toy may sound like a lot but it amounts to almost nothing," commented one industry spokesman. Toxicologist Professor Alan Boobis says there is no evidence such concentrations pose a threat to human health. He sees consumer groups and environmental organisations as guilty of "irresponsible, hysterical scaremongering".
On the other hand Greenpeace spokesman Dr Paul Johnston argues: "Given that we have huge uncertainties about these chemicals' biological activities at low concentrations, should we be exposing the unborn child to them?'
Many companies claim that the level of phthalates in their products is safe. This might be true if people were exposed to just one phthalate from one source at a time. Since many phthalates have similar effects, people could be affected by the total exposure to this group of chemicals. Consumers fear that what appears to be a tolerable level of exposure to a single phthalate could contribute to an unsafe overall exposure.
Burden of proof
The aim of reach is to make the European Union more competitive as the world's largest market for safer chemicals and cleaning products through the registering, evaluating and authorising of 30,000 or so chemicals.
Companies will soon be obliged to register data such as the tonnage used while it will be up to the competent authority (in our case the Malta Standards Authority) to evaluate or assess on a case by case basis. The use of chemicals that exhibit certain hazardous characteristics (such as PBTs and endocrine disrupting chemicals) would be considered of "very high concern", triggering the authorisation process. Use of these chemicals would be banned unless specifically authorised.
According to the European Commission, the direct costs of REACH are about $4 billion over an 11-year transition period. While this may sound large, it represents less that 0.1 per cent of the European chemical industry's annual sales.
There are also indirect costs, which are difficult to estimate. Under the original Commission proposal registration costs for low volume substances would have accounted for almost 10 per cent of the total cost despite the fact that they account for only 0.01 per cent of total exposure to chemicals.
There are great potential savings from the creation of new markets, reduced lower liability and clean-up costs, and reduced costs of the human and environmental impacts of hazardous chemicals. While it is impossible to put a precise figure on the health and ecological benefits of REACH, the Commission estimates the workplace health benefits in Europe at $20-$60 billion over 30 years, and 2,200 to 4,300 avoided cancer cases annually.
An attempt was made by Parliament's Industry and Internal Market Committees to shift the responsibility to request data onto the chemicals agency while leaving 80 per cent of chemicals (for which safety information is not available) to remain on the market without safety ensured by industry.
On October 5 Parliament's Environment and Public Health Committee voted for amendments that would strengthen key passages of REACH, such as the principle for duty of care for industry and the substitution principle ensuring that hazardous chemicals will be taken off the market.
Reach weighs heavily on SMEs and low volume substances. A proposal, which had been made jointly by Malta and Slovenia, on low production volumes of one-ten tonnes was criticised by NGOs. The organisations called for the strengthening of registration requirements on low volume use.
There is a good side to the proposal since it prioritises substances used in consumer products over substances only used in specialised industrial processes. Hand in hand with prioritisation, three further tests for acute toxicity, biodegradation and algal toxicity have been added.
Not all Parliamentary Committees recognised the urgent need for enough safety information to protect workers, public health and the environment adequately or for data necessary to identify the worst chemicals to identify safer ones to replace them.
The consumer group Women in Europe for a Common Future is hoping that the plenary will ensure that this last gap in REACH is closed. "Otherwise we will not achieve a stable and long-term protection of health and the environment in Europe," says WECF policy co-ordinator Daniela Rosche.
While no agreement had been arrived at in the Council until last Tuesday, many member states voiced general support for the approach to REACH as proposed by the UK presidency, which incorporates the main ideas of the Maltese Slovenian proposal while seeking to maintain the concept of placing the burden of proof firmly in industry's lap.
Friends of the Earth Malta has called on Maltese MEPs to vote for the identification and mandatory substitution of chemicals of very high concern. These are the top worst chemicals, which do not break down quickly in the environment (very persistent) and can build up in the human body (very bio-accumulative).
Once released into the environment they cannot be handled safely. The EU has made a commitment to phase them out by 2020.
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