Confusion Reigns on REACH in the Food and Feed Sector*

Originally published March 2005

While the most significant implications of the REACH Proposal should rest towards the top end of the chemical supply chain, there are significant concerns in the food and feed sector that the Proposal will unnecessarily impact upon its business when other European legislation already provides a high level of protection. Confusion surrounds the lack of clarity and consistency with the proposed legislation and intense lobbying efforts continue.

The European Commission issued its proposal for a new Regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals ("REACH") in October 2003 (the "Proposal"). The Proposal aims to provide a regime which protects human health and the environment, increases transparency and promotes non-animal testing.

The Proposal will completely overhaul the current regulatory framework for chemicals in the EU. At present chemicals are divided into "existing" substances and "new" substances (existing substances being those on the market in September 1981 and new substances being those put on the market since that date). While new substances produced in volumes over 10 kg a year are subject to stringent testing to identify environmental and health risks, existing substances are not subject to the same testing requirements. As a result there is very little public information available about the safety of existing substances and there is a view that the testing requirements have discouraged the development of new chemicals. The Commission estimates that of the 106,000 plus existing substances listed on its "EINECS" database, some 30,000 will fall within the scope of REACH as it is currently drafted. However, some stakeholders challenge this figure and believe many more substances will be covered.

The Proposal imposes a general obligation on manufacturers and importers to register substances manufactured or imported into the EC in quantities of 1 tonne or more per year. Substance is defined in the regulation as "any chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition".

There is also an obligation to register substances contained in articles¹ where all three of the following conditions are met: (a) the substance is present in articles in quantities totalling over one tonne per producer or importer per year; (b) the substance is classified as "dangerous"; and (c) it is intended that the substance will be released from the article under normal and reasonably foreseeable conditions of use.

As part of the registration process, manufacturers and importers will have to compile data on the potential hazards of the substance and the risk its use may present. They would also be obliged to conduct a chemical safety assessment and prepare a chemical safety report for all substances that they manufacture or import in quantities in excess of 10 tonnes per year.

Whilst the proposed legislation is aimed primarily at chemicals and the protection of the environment, the definition of "substance" is extremely broad and could therefore cover many substances and ingredients used in food and feed manufacture. The Proposal does however contain a number of exclusions from the requirement to register. These are set out in Article 4 and include, as currently drafted, the following:

• substances used as a food additive or flavouring in foodstuffs within the scope of Council Directive 89/107 or Commission Decision 99/217
• substances used as an additive in feeding stuffs within the scope of Council Directive 70/524
• sustances  used in animal nutrition within the scope of Council Directive 82/471 (that is, amino acids)
• substances included in Annex II or covered by Annex III of the REACH Regulation.

Annex II contains a range of substances including ascorbic acid, glucose, carbon dioxide, water, starch, vitamin A, various oils and various fatty acids. Potentially relevant Annex III exclusions include (i) minerals, ores and substances occurring in nature which are not chemically modified during their manufacturing and are not classified as dangerous under Directive 65/548 and (ii) substances which result from a chemical reaction that occurs when, for example, stabilisers, colorants, flavouring agents, antioxidants, desiccants or emulsifiers function as intended.

Whilst these exclusions serve to remove many of the "substances" used by the food and feed sectors, significant concerns remain about the clarity of the exclusions and some glaring inconsistencies are evident both within and between the Annexes. These include, for example, that sucrose and sunflower oil are specifically exempt under Annex II whilst similar substances such as fructose and coconut oil are not. There is also an apparent inconsistency as some of the substances specified in Annex II would, in any event, appear to be covered by general exclusions in Annex III.

If the Proposal with its lack of clarity and consistency was to be agreed, confusion would reign throughout the sector. Substances manufactured or imported into the EU that are not excluded under Article 4 would need to be registered by the manufacturer or importer. Further, Article 4 only excludes substances from the requirement to register. Whilst many of the other requirements of the Proposal flow from the registration requirements, there are some aspects which are independent of this and which could have significant effects on downstream manufacturers and distributors. These include the requirement to supply safety data sheets for substances classified as dangerous and the requirement on all actors in the supply chain to communicate up and down the chain.

There are also a number of other potential impacts on companies operating in the sector including the following:

• non-food/feed items - companies should consider the effects of the Proposal on their non-food items such as their packaging (but excluding food contact materials which are specifically excluded from registration requirements because they are already subject to specific stringent testing and controls)
• increased costs - whilst the most significant costs will fall to those at the top of the supply chain it is likely that a proportion of these will be passed to downstream users
• public information - much of the information held under the regime will be publicly accessible raising concerns about commercially sensitive information.

Various Member States including the UK have been lobbying for some time for greater clarity on the scope of the Proposal. We also understand that the UK has sought the removal of all food and feed substances from the registration requirements (but not from REACH in its entirety).

Various food and feed industry bodies have been lobbying on the REACH proposal for a number of years. Several of these associations (including the Confederation of the Food and Drink Industries of the EU (the CIAA), the Federation of European Food Additives and Food Enzymes Industries, the European Feed Manufacturers Federation and the European Federation of Animal Feed Additives Manufacturers) have produced a joint position statement requesting that all food, feed and their ingredients are explicitly excluded from the scope of the proposal in its entirety. They submit that the safety of such products is adequately covered by other EU legislation and to include them within the scope of REACH would lead to double legislation and confusion between the responsibility of the European Foods Safety Authority and the Chemical Agency which is to be set up under REACH. It remains uncertain whether the CIAA strategy will succeed in persuading the Commission, Member States and European Parliament that this the correct approach, particularly given the political attention focused on food safety issues in light of the Sudan I incident.

The Proposal is currently being considered at various levels within the EU institutions, in particular, the European Parliament. Whilst it is understood that the European Commission has been persuaded to make a number of amendments to the original text, the principles and objectives of REACH will remain largely unaltered. It is currently anticipated that the European Parliament will adopt an amended version at its first reading during the autumn of 2005.