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Issue 16, 2005 (12 August)
 General and Market Reports

EU's REACH policy enters decisive phase


The debate over the EU's future chemicals policy is about to enter a decisive stage with the European Parliament likely to vote on the REACH proposal in first reading in November/December. This debate has already been described as the biggest lobbying battle in EU history. As reported in Business Alert-EU issue 9/2005, the European Parliament is currently working on the proposed Regulation for the registration, evaluation and authorisation of chemicals, notoriously referred to as the Commission's "REACH" policy. It entered its parliamentary phase in January and all attention will soon be on the European Parliament's vote in first reading. The first reading had initially been earmarked for October, but had to be delayed due to the enormous number of proposed amendments, which has far exceeded a thousand. The Commission, for its part, is trying to assure lawmakers that it will eventually remove the glitches which could make the future policy unworkable.

REACH will affect not only chemicals placed on the market in Europe but also finished products making use of chemicals, such as textiles, toys and electronics. Serious impacts are also expected on specialised chemicals used in the semi-conductor and photographic industries, among others. As such, Hong Kong sellers of all such goods could be directly affected by the future REACH provisions. Under the REACH regulation, health and environmental assessments for more than 30,000 chemicals and substances would be required.

While the current legislation on chemicals provides for a progressive risk evaluation of priority substances, the main responsibility of which lies with the public authorities, REACH will establish a new single regime for all chemical substances. Registration requirements will include the obligation on each manufacturer and importer of substances to register them with a central agency prior to their manufacture or import. Registration dossiers to be submitted to the agency will include information on intrinsic properties, uses and safe ways of handling chemicals. Under the evaluation and authorisation procedures, substances of potential concern will be evaluated, while substances of very high concern will have to be specifically authorised before being placed on the market. For this to occur, an applicant would have to demonstrate that the risks arising will be adequately controlled, or that their benefit to people outweighs those risks and there are no substitutes available.

In the European Parliament, a head-on confrontation is brewing between the centre-right EPP-ED and the Group of European Socialists, supported by the Greens. One of the main issues currently being debated is the claim from those opposing the proposal REACH regulation that it would be too costly and burdensome for SMEs who manufacture chemicals or use them as an integral part of their production processes (so-called downstream users).

A key role in the debate will be played by Socialist MEP Guido Sacconi, as he is reporting for the Committee on the Environment, Public Health and Food Safety, which was designated as the leading Parliament Committee on the REACH proposal.

On 14 July 2005, Guido Sacconi made a move to address SMEs' concerns on REACH and invalidate industry claims that the draft chemicals law is not workable for small and medium sized companies. Sacconi said that claims from the European Chemicals Industry Council (CEFIC) that REACH will push small companies out of business can be overcome.

Under Sacconi's proposal, data registered for small volume chemicals (1-10 tonnes produced or imported per year) would be made available free of charge to SMEs 13 years after REACH comes into force instead of eleven. Such a move, he says, would invalidate CEFIC's claims that REACH is not workable for SMEs as it constitutes most of their chemicals portfolio. According to Sacconi, the measure would concern some 20,000 out of the 30,000 chemicals to be assessed under the REACH process.

Moreover, Sacconi proposes that the Commission reviews the regulation six years after it enters into force, opening the way for the agency to assess remaining untested chemicals according to the risks they pose to human health and the environment instead of volumes -- a view strongly defended by industry.

In brief, the timeline suggested by Sacconi once REACH is in force is as follows:
  • 0-3 years: first wave of registration of substances within the agency (3 year deadline for substances above 1000 tonnes);
  • 6 years: Commission review of REACH;
  • 13 years: data for small volumes (1-10 tonnes) registered in the first 3 years available to SMEs free of charge at the future European chemicals agency in Helsinki.


The chemical industry has called Sacconi's proposal "a good start", but is concerned that the proposal does not resolve potential problem issues for the biggest producers of chemicals concerning patent protection. According to a representative of CEFIC, "If companies cannot protect their production secrets, there is a problem".

Two other crucial questions which have yet to be resolved, and in which Hong Kong sellers may like to actively participate (e.g., by making submissions to the Parliament or Commission), relate to:

  • the fate of imported products containing chemical substances (Article 6 of the proposed regulation). According to Werner Langen, REACH coordinator for the European Parliament's EPP-ED group, "We must find the best solution to take on board the risks and determine how to implement it. This solution must be compatible with WTO rules". Langen is in favour of imported products being subject only to the pre-registration obligations; and
  • the extent to which downstream products, such as electronics, car parts and packaging, but also textiles, toys, photographic equipment, semi-conductors, etc., will need to be regulated under REACH. As well as MEPs, Member States have also expressed concern that the REACH proposal may infringe the EU's WTO commitments. As such, the greater the number of products that fall under REACH, the greater the likelihood of creating obstacles to trade and consequent WTO disputes.