Регламент REACH: Регистрация, оценка, авторизация и ограничение химических веществ

European Union regulation

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will affect industries throughout the world. REACH entered into force on 1 June 2007, with a phased implementation over the next decade. The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH.

The European Commission's (EC) White Paper of 2001 on a 'future chemical strategy' proposed a system that requires chemicals manufactured in quantities of greater than 1 tonne to be 'registered', those manufactured in quantities greater than 100 tonnes to be 'evaluated', and certain substances of high concern (for example carcinogenic, mutagenic and toxic to reproduction – CMRs) to be 'authorised'. The EC adopted its proposal for a new scheme to manage the manufacture, importation and supply of chemicals in Europe on in October 2003. This proposal eventually became law once the European Parliament officially approved its final text of REACH. It came into force on 1 June 2007.

One of the major elements of the REACH regulation is the requirement to communicate information on chemicals up and down the supply chain. This ensures that manufacturers, importers, and also their customers are aware of information relating to health and safety of the products supplied. For many retailers the obligation to provide information about substances in their products within 45 days of receipt of a request from a consumer is particularly challenging. Having detailed information on the substances present in their products will allow retailers to work with the manufacturing base to substitute or remove potentially harmful substances from products. The list of harmful substances is continuously growing and requires organizations to constantly monitor any announcements and additions to the REACH scope. This can be done on the European Chemicals Agency's website.

Manufactures and importers should develop risk reduction measures for all known uses of the chemical including downstream uses. Downstream users such as plastic pipe producers should provide detail of their uses to their suppliers. In cases where downstream users decide not to disclose this information, they need to have their own CSR.

REACH is the product of a wide ranging overhaul of EU chemical policy. It passed the first reading in the European Parliament on 17 November 2005, and the Council of Ministers reached a political agreement for a common position on 13 December 2005. The European Parliament approved REACH on 13 December 2006 and the Council of Ministers formally adopted it on 18 December 2006. Weighing up expenditure versus profit has always been a significant issue, with the estimated cost of compliance being around €5 billion over 11 years, and the assumed health benefits of saved billions of euro in healthcare costs. However, there have been different studies on the estimated cost which vary considerably in the outcome. It came into force on 20 January 2009, and will be fully implemented by 2015. A separate regulation – the CLP Regulation (for "Classification, Labelling, Packaging") – implements the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and will steadily replace the previous Dangerous Substances Directive and Dangerous Preparations Directive. The REACH regulation was amended in April 2018 to include specific information requirements for nanomaterials. In the European Green Deal of 2020, a commitment was made to update the REACH regulation to ban between 7,000 and 12,000 toxic substances in all consumer products, except where truly essential. The goal was among the priorities of the European Commission, but is in danger of being radically revised due to lobbying by the EU chemical industry and the positions taken by the European People's Party.

The legislation was proposed under dual reasoning: protection of human health and protection of the environment. Using potentially toxic substances (such as phthalates or brominated flame retardants) is deemed undesirable and REACH will force the use of certain substances to be phased out. Using potentially toxic substances in products other than those ingested by humans (such as electronic devices) may seem to be safe, but there are several ways in which chemicals can enter the human body and the environment. Substances can leave particles during consumer use, for example into the air where they can be inhaled or ingested. Even where they might not do direct harm to humans, they can contaminate the air or water, and can enter the food chain through plants, fish or other animals. According to the European Commission, little safety information exists for 99 percent of the tens of thousands of chemicals placed on the market before 1981. However, many of these substances may bioaccumulate in the human body, thus reaching dangerous concentrations. They may also chemically react with one another, producing new substances with new risks.

A number of countries outside of the European Union have started to implement REACH regulations or are in the process of adopting such a regulatory framework to approach a more globalized system of chemicals registration under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Balkan countries such as Croatia and Serbia are in the process of adopting the EU REACH system under the auspices of the EU IPA programme. Switzerland has moved towards implementation of REACH through partial revision of the Swiss Chemical Ordinance on February 1, 2009. The new Chemicals Management Regulation in Turkey is paving the way for the planned adoption of REACH in 2013. China has moved towards a more efficient and coherent system for the control of chemicals in compliance with GHS. In the UK, the government announced a "UK REACH" that the UK's Chemical Industry Association described as a "hugely expensive duplication" of the EU's safety data. The new regulations were to be enforced from October 2021 but deferred to October 2023, and then to October 2025. Following industry representations, the responsible Minister announced "that officials would now explore 'a new model' for UK REACH registrations that would look to 'reduce the need for replicating EU Reach data packages'". The cosmetics company Lush were critical of the legislation when it was first proposed in 2006, as they believed it would increase animal testing. The cosmetics company wrote to its European customers and also ran an in store marketing campaign, asking for postcards objecting to the legislation be sent to MEPs, a move which resulted in 80,000 Lush customers sending postcards. In December 2006, Lush protested outside the European Parliament in Strasbourg, by dumping horse manure outside the building. An opinion in Nature in 2009 by Thomas Hartung and Constanza Rovida estimated that 54 million vertebrate animals would be used under REACH and that the costs would amount to €9.5 billion, set against the annual European industry annual turnover of €507 billion. Hartung is the former head of European Centre for the Validation of Alternative Methods (ECVAM). In a news release, ECHA criticised assumptions made by Hartung and Rovida; ECHA's alternative assumptions reduced sixfold the number of animals.

Only representatives are EU based entities that must comply with REACH (Article 8) and should operate standard, transparent working practices. The Only Representative assumes responsibility and liability for fulfilling obligiations of importers in accordance with REACH for substances being brought into the EU by a non EU manufacturer. Non EU consultancies offer "only representative" services, though according to REACH it is not possible to register a substance if your "only representative" consultancy company is not based in the EU, unless it is subcontracted to an EU based registrant. The SIEFs will bring new challenges. An article in the business news service Chemical Watch described how some "pre registrants" may simply be consultants hoping for work ("gold diggers") while others may be aiming to charge exorbitant rates for the data they have to offer ("jackals").

The European Chemical Agency (ECHA) has published the REACH Authorisation List, in an effort to tighten the use of Substances of Very High Concern (SVHCs). The list is an official recommendation from the ECHA to the European Commission. The list is also regularly updated and expanded. Currently the Candidate List for Authorisation comprises a total of 233 SVHCs (see ECHA list at https://echa. europa. eu/candidate list table), some of which are already active on the Authorization List. To sell or use these substances, manufacturers, importers, and retailers in the European Union (EU) must apply for authorization from the ECHA. The applicant is to submit a chemical safety report on the risks entailed by the substance, as well as an analysis of possible alternative substances or technologies including present and future research and development processed.