Through our European federation, EUROFER, we are a member of the REACH Alliance, which represents 12 sectors involved in inorganics – cement, ceramics, glass, gypsum, iron/steel, lime, minerals, non-ferrous metals, ores, precast concrete and ready mixed concrete. The REACH Alliance is involved in the EU Commission’s Regulatory Impact Assessment, and there are also likely to be sector-specific business studies carried out shortly.

The Metals Forum (EUROFER and Eurometaux) are working on the project MERAG/HERAG – a Technical Guidance Document for the risk assessment of the environment and health effects of metals and alloys. The UK has sponsored the MERAG/HERAG project, which is also supported by France and Germany. The MERAG (environment) project is planned to commence in 2004 and a Steering Group (Eurofer is a member) has already been formed to fund and develop the programme. Similar action is planned for the HERAG (health) project in 2005.

Key Points

Prioritisation Based on Risk

EEF believes it is important that the REACH system addresses chemicals and substances of the highest concern before any others. The early registration of CMR substances and others of similar concern is a welcome one. However, there are still a sizeable proportion of the 30,000 chemicals which will be brought into the system on a production tonnage basis. This would mean that substances in every day use such as steel and stainless steel would be required to register within 3 years of the Regulation coming into force.

The European metals and inorganics sector has a production volume of 1.5 billion tonnes a year this is over four times the estimation of the total tonnage covered by REACH in the original White Paper. Even though the metals sectors produce in high quantities, the majority of metals and their products do not present a significant risk to the environment or human health. For example many people are closely exposed to steel and stainless steel products every day of their lives, without any adverse effect.

There is a popular misconception that all ‘chemicals’ have an ‘adverse impact’ on the environment and human health. Media and pressure groups have exaggerated and fuelled this misconception and portrayed REACH as the saviour for the public against ‘toxics’. This situation could be improved if a sensible focus on the substances of highest hazard and risk was taken. Industry is looking for a workable system that will help everyone to manage substances responsibly.

Impact on Innovation

Chemicals and substances are extremely valuable within society and EU companies already comply with strict legislation to minimise impacts and have an interest in protecting the health of their staff and customers. The EU has world leaders in manufacturing and it is vital that their innovation and productivity is not stifled unnecessarily by this proposed system.

Impact on Competition

Due to high production tonnages, the metal producers will be required to submit registration dossiers within the first 3 years of the Regulation coming into force. The sector and its suppliers could find themselves in the middle of expensive testing plans at a very early stage in the phased implementation programme.

Government must make it clear that at present the REACH proposal will cover all substances, not just the ‘hazardous’ or ‘toxic’ chemicals. The proposal has been specifically written for dealing with organic and inorganic chemicals but in fact will cover a much wider range of substances, such as metals, ores, cement and engineering oils. We welcome and are very involved in the second regulatory impact assessment being carried out by the EU Commission, in conjunction with CEFIC and UNICE.

The impact of iron based metals in the massive form is not an issue for public health in terms of dermal, ingestion or inhalation entry. Metal ions in suspension will have different issues and the two forms should not be confused, as they currently are in this legislation.

One Substance, One Registration

EEF supports the government’s proposal for one substance, one registration (OSOR) in principle. We are concerned that the REACH proposals as they stand will be unworkable so are in favour of measures that reduce bureaucracy and introduce economies of scale and efficiency.

We believe that the proposal in Annex A is a broad one and still raises questions about how OSOR would operate in practice. We do not believe that OSOR should inevitably link to mandatory consortia. We are opposed to mandatory consortia because there will be examples of companies who can not share data on grounds of commercial confidentiality. We also question whether a Europe-wide mandatory consortia for one substance would be administratively simple or cost effective. We would prefer to see a flexible approach that allows for other systems such as a leading company or brokerage. This would leave our members free to choose the option that best suits their business. We believe that the present proposals for OSOR would have implications for smaller companies, as their production volumes would be rolled up with a group of other producers. This would result in higher overall production tonnages that would bring them into the REACH system much earlier. We understand that DEFRA, having already listened to these concerns, are developing their thinking on OSOR and support their ideas for limiting the mandatory element to registration of the intrinsic properties of a substance, whilst allowing companies to individually register their usage scenarios. We also support the principle of one registration for a group of substances.

Alloys

With regard to alloys, innovation is gradual and cumulative. It is not as simple as replacing one substance with another. The existing classification and labeling system is inappropriate for dealing with metal alloys. We must reduce the regulatory burden on metals and alloys in the massive form and ensure that there is a proper definition of alloys. In addition, recycled materials such as alloy scrap should be exempted from REACH.

Substitution

It is essential that the substitution requirements of REACH are not mandatory. There are practical issues which make it extremely difficult to substitute one substance for another. For example, the Health and Safety Executive might prefer a more hazardous substance that is used in a very low risk situation (e.g. enclosed system), to a less hazardous substance whose use involves a higher risk (e.g. greater exposure).

Customers can make requirements and specifications for their products that make it almost impossible for suppliers to make changes while still keeping the contract. In some cases these requirements are also for reasons of safety, or because they are demanded in customer specifications.

Waste

The steel industry uses and sells a high proportion of recycled material. It is essential from an economic point of view that this material is not covered by REACH.

Unless this is agreed, there will be a clash between the Producer Responsibility initiatives that require use of higher quantities of recyclate in new materials (e.g. End of Life Vehicles Directive) and REACH. When recycled substances are used to make products, will these have to be tested according to REACH? In some cases, member states are struggling to develop successful markets in recyclate, for example, with recycled plastics. Requiring these substances to be tested once they have been recycled would unfavourably affect the economic viability of the process.

The European Commision’s Directorate General (DG) Enterprise produced a “non-paper on waste”, which was intended to clarify the extent to which REACH will apply to waste, but unfortunately it failed in this objective and an addendum was produced by DG Environment. Neither the non-paper nor the addendum provided a definitive answer to the concerns raised by industry. These documents indicate that steel scrap would be exempt from registration, but some other by-products used as a feedstock by other industries may require Registration.

Response to Specific Consultation Questions

Q 1 Definitions

The government would welcome views on the definitions outlined in Article 3.

EEF is in full agreement that a definition of a ‘substance’ is key.

Steel and other metallic alloys are special preparations that have their own specific properties. This should be acknowledged in the definitions, and the UN-agreed definition of metallic alloys needs to be included, as is the case for “polymers”, to ensure recognition of, and workability for, metallic alloys.

Q2 Excluding Polymers and Intermediates

Do consultees agree with the government approach to limit the scope by excluding lower priority chemicals such as certain intermediates and polymers in the first stages of REACH as outlined in the European Commission proposal?

EEF supports the exclusion of intermediates but seeks clarity about which substances or preparations are classified as intermediates or isolated intermediates. With regards to steel there are many constituents used in the production of a final product. For example:

• Substances used in steel (e.g. iron, nickel, chromium, etc)
• Substance used during the production of steel (e.g. pickling acids)
• Substances used on steel (e.g. zinc, chromates, etc)
• Substances that are by-products (e.g. slag)

Government would benefit from addressing such practical questions at this early stage, in order to help companies (particularly SMEs) assess the practical extent of the REACH proposals.

Q3 Exemptions

The government would welcome views on whether the exemptions from registration outlined in Annex II and Annex III under this Regulation are appropriate.

The main substances that our members use and produce, such as iron ore, steel and stainless steel are not a toxicological priority. However they are produced in large tonnages which, under the present design, would require them to register within three years of the regulation coming into force.

It is important that there is not an over-zealous interpretation of the annexes.

In line with other exemptions for raw materials in the regulation, is essential that iron ore exempted from the regulation. To ensure fair competition between different industry sectors, minerals and ores (the raw materials for the metals sector) should be exempted from the obligation to register, as is the case for the raw materials for the organic chemicals sector (i.e. coal, natural gas and crude oil).

The metal, iron, a significant component of the earth’s crust, and essential for life, should be excluded from registration as the cost of testing (including testing on laboratory animals) and registration would significantly outweigh any potential benefit.

In addition, the process gases produced in coke ovens and integrated steel mills are used like natural gas, oil and coal to produce energy and heat. They should also be exempted from the obligation to register.

The regulatory burden on metals and alloys in the massive form should be reduced in proportion to their limited potential to represent risk to human health or the environment. For example, we advocate that the every day use of stainless steel and steel items for hundreds of years proves that they are not harmful to public health or the environment.

There should be consideration of the large number of metal alloys that are produced and used.

Wastes for recycling should not be within the scope of REACH, because they are already well controlled and managed by other EU and international waste legislation.

Q4 Substances in Articles

Is the proposal for substances contained in articles workable and likely to provide adequate protection from chemicals in articles? If not, what alternative approach could be used?

It is vital that the EU Commission close this loophole. It is possible that companies could be importing finished articles into the EU containing banned substances. The introduction of REACH will have no impact on these producers of goods, representing a major competitive advantage over producers of the same goods located within the EU. The major impact of this could be that companies switch production to their manufacturing facilities outside the EU to minimise their production costs (i.e. REACH registration and testing). We must ensure that producers of imported goods take account of the constituent substances in the same way as producers in the EU will be forced to under the REACH proposal.

EEF believes that the failure to apply REACH requirements to constituent substances of finished articles imported into the EU leaves a loophole that will have impacts on competitiveness, whilst not helping to improve any environmental or human health protection. Companies producing equivalent products within the EU will have to have the constituents tested under REACH and may move production out of the Community in order to maintain production costs and competition with India, the Far East and the USA.

The same REACH system should apply to all imports, whether they are substances or finished articles. This is one element of the proposal on which we agree with the green groups, who want a level playing field to encourage all companies to substitute hazardous substances for less harmful ones. There are at least two precedents for applying the same system to imported whole products already in EU legislation – the End of Life Vehicles Directive where importers must require self declaration from suppliers that components do not contain banned substances, and the Cosmetics Directive, where producers importing cosmetic products must provide testing information

Q6 ‘One Substance, One Registration’ (OSOR)

EEF supports this proposal in principle. We are concerned that the REACH proposals as they stand will be unworkable, so are support of proposals that would reduce bureaucracy and introduce economies of scale and efficiency.

The proposal in Annex A is broad and still raises questions about how it would run in practice.
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Government should not make the assumption that OSOR is inevitably linked to a mandatory requirement to join consortia. This should be left to companies to decide voluntarily.

We question whether it would be practical to achieve one mandatory consortium for one substance across the whole of Europe?

We understand that DEFRA, having already listened to these concerns, are developing their thinking on OSOR and support their ideas for limiting the mandatory element to registration of the intrinsic properties of a substance, whilst allowing companies to individually register their usage scenarios.

Confidentiality

There will be issues of commercial confidentiality, where competitors would risk intellectual property or market advantage if they were to share data that led others to surmise the formulation of substances, preparations or products. Some companies may be put off by the risk of competitors seeing this information to the extent that they choose not to participate, even under a mandatory framework.

Impact on SMEs

OSOR as proposed could also have an unfavourable impact on smaller companies. If the assumption is made that smaller companies produce smaller quantities of chemicals (although there will of course be exceptions), then under the current plans, they may not be required to register for 11 years. However, if OSOR requires companies to club together, and in so doing, amalgamate their production tonnages for the substance, then the higher amounts would bring the registration date forward.

One Registration for Groups of Substances

We see an attraction in the idea of one registration for a group of like substances. We accept the difficulty that exists currently in identifying whether one substance is present on the market under a number of different sales names, but believe that there are enough groups of substances with very similar properties to warrant this as an efficiency measure.