A future for the EU's future chemicals policy?

To respond to concerns that have arisen on issues such as relatively low levels of air pollution, endocrine disrupting chemicals in the environment, and possible environmental and human health effects, the European Commission published a White Paper: A Strategy for a Future Chemicals Policy. This proposes that all chemicals – new and existing – produced in quantities of greater than one tonne be tested and registered in a very short space of time.

Judith Hackitt, the Chemical Industry Association's new director general, is at pains to point out that the chemical industry supports the White Paper's aim of ensuring a high level of protection for human health and the environment. 'We are ready, willing and able to be constructive, but this proposed legislation is the most important issue for the chemical industry, as a whole, by far.' However, she said that if the legislation goes through as it is: 'Chemicals will be withdrawn for the wrong reasons.'

The centrepiece of the legislation is the proposed creation of a regulatory system, the registration, evaluation and authorisation of chemicals (REACH), under which some 30,000 chemical substances are to be tested by 2012 for their effects on health and the environment. The cost of this is to be met by chemical producers and importers, and the cost of testing is estimated by the EC to be €2.1bn (US$1.9bn), and by Cefic at €8bn ($7.3bn). Table 1 illustrates the effect of adding the costs of testing onto the prices of a range of goods produced at different volumes. 'It shows that for chemicals produced in small tonnages the cost of testing under the white paper will be extremely burdensome,' said Jon Morris, head of KPMG's European Chemicals practice.¹

animal testing

The question of the number of animals needed for testing has also been questioned. While the White Paper suggests that the levels of animal testing will not increase, figures of 10-12m have been bandied around.² As Hackitt said: 'It may not be an exaggeration, but whether it is 10m or 5m, I don't really care – it's still far too many. We need to reduce the level of animal testing to an absolute minimum.' This was something brought out in a House of Lords' committee report,³ which stated that any new chemical policy should focus on products placed in the market before 1981.

'We need a proportionate and intelligent approach to the problem, that minimises costs and stimulates investment, because if we don't, and the process constipates innovation within the industry, then what use is that to industry or society? All the approaches need to be built into minimising the amount of resources that have to be consumed.'

Another aspect that concerns Hackitt is the effect the costs will have on competitiveness. Building on the fact that the registration process will result in each substance receiving a unique registration, the right to market and use the substance within the EU would have to be some form of approved supplier status. 'Therein lies the dilemma: if you impose what are effectively trade restrictions, people say: "Trade barrier" – but if you don't, you are engaging in a morally indefensible con of the public, because you are moving the problem from the EU to other countries.'

threat to competitiveness

As the CIA said in a paper on the EU Chemicals Policy:⁴ 'While appreciating that these proposals would bring an increased burden for the EU chemical industry, the dangers of ignoring the potential threat to the industry's competitiveness are quite apparent. What cannot be ignored, however, is that real solutions are essential, if we are to secure protection for the competitiveness of the EU chemical industry.'

'Do we want to give away our position as a leader in the world's chemical industry? It just doesn't make sense to me,' Hackitt commented.

So how will implementation affect the pharmaceutical industry? Hackitt pulls no punches in expressing her concerns that trade organisations either do not realise the possible implications or do not want to recognise the problems. 'I think the ABPI, along with many other downstream trade organisations, are sadly mistaken if they do not believe the regulations will affect their members,' she said.

This is especially the case where pharma companies have their intermediates produced by contract chemical manufacturers. 'We are arguing strongly there is no point in testing intermediates because there is no environmental exposure, but if we lose that battle then the pharma industry's supply chain is going to be severely impacted.'

Another potential effect of the legislation that pharma companies have perhaps failed to recognise is that if they are going to buy a substance from an intermediates manufacturer, they will need to tell the supplier all the applications the substance is going to be used for. This could infringe intellectual property rights, but unless the buying company is prepared to do the testing, they will have to reveal usage. There could be some unpalatable choices for companies.

Hackitt concluded: 'It is the time for the industry to tell the Commission that we are committed to the aims of the White Paper, but the means must be more sensible, so that we can face the future with at least some confidence.'