REACH FAQs

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What is REACH?

REACH is a new European regulation on chemical substances. The abbreviation stands for Registration, Evaluation and Authorisation of CHemical substances. REACH's core is that businesses must in principle know the risks of all substances they produce, process or pass to customers and identify measures (and for their own business also take these measures) to manage the risks. The introduction of REACH shifts the responsibility for proper risk management of chemical substances onto business.

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What is the aim of the REACH regulations?

For many chemical substances on the market in Europe, insufficient data is available on the hazards and risks they pose. With the introduction of REACH, companies must map out the risks of substances on the basis of information about characteristics, use and exposure and, if necessary, even take safety measures and provide their customers with recommendations. REACH's aim is to guarantee a high level of safety for man and the environment in the production and use of chemical substances, whilst maintaining or improving the competitiveness of the industry. In order to achieve this, information about substances that are used will become available as a result of REACH and communication in relation to those substances will be improved from the producer down to the end-user (both downstream and upstream).

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Who is affected by REACH?

Everyone who in the course of business produces, imports into the EU, distributes or uses chemical substances or preparations is affected by REACH. Hence, REACH also relates to those who use substances, preparations and some types of objects in the course of their business. Within REACH, three groups of players are differentiated: manufacturers/importers, distributors, and users. Each of them has a different role and different obligations under REACH. A business that is affected by REACH must therefore examine what role it plays under REACH. A single business may fulfil several roles; thus, a manufacturer of a given chemical substances will frequently also be a user of chemical substances.

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What substances does REACH apply to?

In principle, all chemicals fall under REACH, except a number of specific categories including radioactive and waste substances. REACH covers the substances themselves as well as substances incorporated into preparations or objects (plasticisers in plastics are an example). One factor determining what obligations apply is the quantity of substance that a company manufactures/uses. Chemicl substances in foodstuffs and drugs fall under other EU legislation. Natural substances are also excepted from REACH registration unless they are hazardous or chemically altered.

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What timelines apply to REACH?

The regulation came into force on 1 June 2007. There will be a transitional phase in which the existing regulations remain in force. For the Prohibition Directive and the notification of new substances, this is one year; for the Existing Substances Directive it is two years. Producers or importers of chemicals that produce or import more than 1 ton of the substance in question must pre-register the substance with the European Chemicals Agency (ECHA) between 1 June and 1 December at the latest. If this deadline is not adhered to, those businesses must terminate the production or importation of the substances until such time as the complete registration application has been lodged. These dates (2010, 2013 or 2018) are dependent on the quantity and sort of chemicals produced, distributed or imported.

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What sorts of obligations are involved?

Manufacturers and importers are under an obligation to register chemicals with a data set concerning safety for man and the environment. Various deadlines and a variety of requirements apply as to the degree of detail in the data, depending inter alia on the volume and harmful characteristics of the substance. Information on risks and measures for managing them have to be passed on between businesses in the chain. Users of chamicals (whether or not in preparations or objects) give their suppliers information about that use for the purpose of preparing or adjusting a registration. For the chemical substances causing most concern, a prohibition is introduced, with the EU being able to grant authorisation for production and use under strict conditions.

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What organisational changes does REACH entail?

In the implementation of REACH, business is faced with the challenge of radically rethinking how it is organised. The REACH regulation generates a system of registration obligations that apply to chemical substances and preparations in consumer objects. Immediately chemicals are used in the primary process, REACH comes into play and far-reaching changes are unavoidable. There are a number of facets to this change process. Insight is required into the strategic risks of REACH and the organisation's capacity has to be aligned to issues of risk management. Obligations have to be actively prevented and supply problems avoided. Used substances may disappear from the market because of the rules. IT processes to safeguard the administration of chemicals have to be mapped and adjusted. Internal work processes have to be adapted in a timely and effective manner. And, finally, the administrative organisation must be flexible in order to remain compliance with the constantly shifting regulations.

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Why such a big 'operation' for regulating substances? Are they so poorly regulated at the moment?

At the present time, little or nothing is known about the possible negative effects on man and the environment of the vast majority of the many tens of thousands of chemicals on the market. This knowledge deficit causes uncertainty as to the quality and safety of the surroundings in which we live and work. In addition, information that is available is not passed on down the chain (from producer to customer to consumer). Not to mention public access to such information. Because of the lack of information and non-sharing of the knowledge that exists, both producers and users find it burdensome to assume their responsibilities. Hence the new rules, which depart from the current European chemicals policy. Under them, governments are responsible for providing information on which the permissibility of chemicals can be judged.

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Does REACH entail a lot of costs for businesses?

The drafters of the law take the view that the costs for meeting the REACH requirements are in the long term comparable or even a little less than under the current rules. During the introductory period (11 years), the costs are temporarily higher. This is the result of a catching-up process, which is needed because the division of responsibility was previously wrong: business has unwarrantedly not borne much of the cost for making data about chemicals available.

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What has changed in the legislation?

The directly applicable REACH regulation supersedes around sixty existing European directives and regulations, including the Substances Prohibition Directive (Directive 76/769/EEC, prohibiting bringing substances onto the market and deploying them) and the Existing Substances Regulation (Regulation 793/93/EEC, governing the evaluation of existing substances that are produced in large volumes). The current Substances Directive (67/548/EC, governing the classification and labelling of substances and the evaluation of new substances) is also amended; many of its obligations have been incorporated into REACH. Because a regulation is of direct effect, it does not need to be transposed into Belgian law. However, penalties for offences and the designation of court jurisdictions is regulated at a national level.

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How does REACH relate to the globally harmonised system (GHS)?

The globally harmonised system (GHS) is a new worldwide agreement for the classification and labelling of chemical substances. For implementation of the GHS in the EU, a new regulation is being drawn up. GHS and REACH are closely connected with each other: the European implementation of GHS forms a substantive development of the classification and labelling part of the REACH regulation.

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Sources:

PwC survey
 

European Commission/ECHA publications