European Union - Hazardous Materials

Classification and labeling of dangerous substances and preparations are legislated in a series of Directives derived from 67/548 EEC which had gone through numerous “Amendments” and “Adaptations to Technical Progress.” Under these Directives, a “chemical” was either a pure “substance,” such as pure nickel or a nickel compound or a “preparation,” such as nickel alloys. In the case of substances, certain classification procedures were applied in categorizing the “hazard” of a substance. In the case of preparations, limit concentrations of the hazardous substance contained in the preparation are imposed and the preparation is categorized by these limits.

On 18 December 2006 the Council of Ministers adopted a new EU regulatory framework for Registration, Evaluation, and Authorisation (and restriction) of Chemicals (REACH). The European Chemicals Bureau (ECB) has the responsibility of developing methodologies, tools and technical guidance needed for REACH through a number of REACH Implementation Projects (RIPs).

REACH entered into force on June 1st 2007 to streamline and improve the former legislative framework on chemicals in the European Union (EU). REACH places greater responsibility on industry to manage the risks that chemicals may pose to the health and the environment. In principle REACH applies to all chemicals: not only chemicals used in industrial processes, but also in day-to-day life (e.g., cleaning products, paints).

REACH replaces more than 30 pieces of legislation with a single Regulation. Other legislation regulating chemicals (e.g., cosmetics, detergents) or related legislation (e.g., on health and safety of workers handling chemicals, product safety, construction products) that were not replaced by REACH will continue to be in force. REACH is intended not to overlap or conflict with the other chemical legislation.

REACH makes industry bear most responsibilities to manage the risks posed by chemicals and provide appropriate safety information to their users. The regulation also enables the European Union to take additional measures (e.g., banning use) on substances considered “highly dangerous”

(e.g., carcinogens, mutagens, or reproductive toxicants or CMRs). REACH also creates the European Chemicals Agency (ECHA) with a central coordination and implementation role in the overall process.

In essence, REACH requires all manufacturers and importers of chemicals to identify and manage risks linked to the substances they manufacture and market. For substances produced or imported in quantities of 1 ton or more per year per company, manufacturers and importers need to demonstrate that they have appropriately done so by means of a registration dossier submitted to the ECHA.

Once the registration dossier has been received, the Agency may check that it is compliant with the Regulation and will evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals. Where appropriate, authorities may also select substances for a broader substance evaluation to further investigate substances of concern.

REACH includes an authorization system aiming to ensure that substances of very high concern are adequately controlled, and progressively substituted by safer substances or technologies or only used where there is an overall benefit for society of using the substance. These substances will be prioritized and over time included in Annex XIV. Once they are included, industry will have to submit applications to the Agency on authorization for continued use of these substances. In addition, EU authorities may impose restrictions on the manufacture, use or placing on the market of substances causing an unacceptable risk to human health or the environment.

Manufacturers and importers must provide their downstream users with the risk information they need to use the substance safely. This will be done via the classification and labeling system and Safety Data Sheets (SDS), where needed.

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