On June 1, 2007, the Registration, Evaluation and Authorization of Chemicals (REACH) regulation came into force in the European Union. REACH is a comprehensive regulation governing the import, manufacture and distribution of chemicals in any European Union member state. It stipulates that no substance may be manufactured or marketed in the European Union unless it has been registered with the European Central Agency in accordance with the regulation. As such, any Canadian or U.S. company that intends to offer chemical products or items containing such products in a European Union member state has to comply with REACH, regardless of whether it does business in Europe directly, through a subsidiary, or through an independent distribution network.
Ultimately, REACH empowers the European Chemicals Agency to work together with member states and prioritize registered substances for evaluation and subsequent regulation or restriction in the European Union.
What is covered by REACH?
REACH applies to substances, preparations (i.e., combinations of substances ) and articles (i.e., manufactured objects containing substances) designated in the regulation. Virtually any chemical substance or combination thereof falls within the ambit of REACH unless it is specifically excluded.
What is not covered by REACH?
Despite its broad application, REACH creates significant exemptions from regulation in a number of categories. The different exemption categories are enumerated in Article 5 and generally are as follows:
- Substances used in medicinal products for human and veterinary use;
- Substances used in food, food additives, or in animal feedstock;
- Substances used in cosmetic products;
- Substances for which "sufficient information is known … that they are considered to cause minimum risk because of their intrinsic properties" - substances in this category are individually listed in Annex IV and include various plant fats, sugars, fatty acids, elemental substances like carbon and nitrogen, as well as water;
- Substances for which registration is "deemed inappropriate or unnecessary" because the exemption does not prejudice the objectives of REACH – substances in this category are individually listed in Annex V and include unintended process intermediates or byproducts, certain naturally occurring substances such as minerals, ores, natural gas, crude oil, coal and coke, as well as certain elemental substances for which risks are "already well-known", such as oxygen, hydrogen, nitrogen and noble gases;
- Non-isolated intermediates (i.e., substances occurring in a process to generate another substance);
- Polymers, which are exempted based on the recognition that there is currently no cost-effective way to assess the effects of every existing polymer - REACH does empower the European Commission to propose new legislation for choosing polymers for registration based on "sound technical and valid scientific criteria", but since a number of polymers that have come under fire for potential adverse health effects are in wide-spread use in every conceivable application, any such proposals will most likely involve drawn-out stakeholder consultation;
- Waste, which is specifically exempted from the definition of "substances, preparations or articles" in order to be regulated under existing European Union regulations.
What do I have to do to comply?
Any individual manufacturer, importer or distributor exceeding a threshold quantity has to register the substance with the European Chemical Agency and supply a technical dossier together with the registration. The dossier has to include:
- Identification of the manufacturer and the substance;
- Information as to classification and labelling of the substance;
- Guidance on safe use;
- Study summaries of safety studies following the methodology set out in the regulation;
- "Robust study" summaries for certain categories (these are summaries that are detailed enough to assess the study without consulting the full report);
- An indication as to what information has been reviewed by a qualified assessor;
- Proposals for testing the health and safety effects of the substance in accordance with the regulation;
- For substances imported in quantities between 1 and 10 tonnes per year, exposure information; and
- A request as to what information provided should not be made available on the internet and justification why publication would harm commercial interests.
In addition, for any substance manufactured, imported or distributed in a quantity of more than 10 tonnes per year, a Chemical Safety Assessment has to be conducted that studies effects on human health, physicochemical hazards, environmental health, and PBT (persistence, bioaccumulation, toxicity). If based on such a study a substance is classified as dangerous, PBT or vPvB (very persistent and very bioaccumulative) exposure scenarios have to be assessed as well.
REACH also requires manufacturers, importers and distributors to create detailed Safety Data Sheets for registered substances. These Safety Data Sheets must be communicated down the supply chain. If the information is not provided to distributors, they will not be allowed to sell.
Important Phase-In Dates
The regulation is being phased in over a period of 11 years. Depending on annual quantities, different deadlines apply to the full registration of "phase-in substances" (substances that are listed on the European Inventory of Existing Chemical Substances (EINECS) or have been manufactured and/or marketed in a current member state within a period 15 years before REACH was passed). No such transition period is provided for non phase-in substances.
Deadlines for phase-in substances are as follows:
November 30, 2008
End of the pre-registration phase. To avail themselves of the three phase-in dates below, existing manufacturers and importers of phase-in substances had to pre-register the basic information. New entrants to the market are still eligible for the phase-in period despite the expiry of the pre-registration deadline.
November 30, 2010
Deadline for full registration of any substance imported, manufactured or distributed in a quantity of 1,000 tonnes per year or more, any substance that is very toxic to aquatic organisms and imported in a quantity of 100 tonnes per year or more, and any substance that is carcinogenic, mutagenic or toxic to reproduction and imported in a quantity of 1 tonne per year or more. May 31, 2013
Deadline for the registration of any substance imported, manufactured or distributed in a quantity of 100 tonnes per year or more.
May 31, 2018
Deadline for the registration of any substance imported, manufactured or distributed in a quantity of one tonne per year or more.