By Peter Douben (REACHWise) & Joost Dekker (REACH ExpertDesk)

REACH: Registration, Evaluation, Authorization and Restriction of Chemicals

The new European REACH regulation (1907/2006/EC) entered into force on June 1st, 2007. The objective of REACH is to ensure a high level of safety when producing and using chemical substances in the EU. An additional objective of REACH is to “assure the free movement of chemicals within the EU market and enhance innovation and the competitiveness of the EU based chemical industry." At the same time, REACH streamlines the existing EU’s legislative framework on chemicals.

In practice, REACH gives industry greater responsibility to manage and reduce the risks that chemicals may pose to health and environment, thus changing the burden of proof from the authorities to industry more explicitly.

In order to prove safe use, a substantial amount of new information on substance properties is required. The requirement to obtain this information with a minimum of animal testing (specifically using vertebrates only as a last resort) has been built into the Regulation. To make this possible, a system has been set-up that enables the sharing of data among potential registrants while maintaining  a certain level of confidentiality. Others who own data that they wish to share  (the so-called “data-holders”) can participate in this process even though they do not need to register themselves.

As a result, REACH is considered to be one of the most complex regulatory changes ever to impact the chemical industry.

REACH impacts all companies that have dealings with chemical products
Industry has to prove safe use of the substances it puts on the market. This is done in a registration process that requires insight in (hazard) properties of substances, how substances are used throughout the entire supply chain (in all life stages) and what the exposure levels of humans and the environment are to these substances.
REACH therefore affects all companies that have dealings with chemical products: manufacturers, importers, downstream users and distributors. Depending on their roles under REACH, companies have different obligations. 

REACH requirements are stricter on manufacturers and importers (who put the substances on the market) than on downstream users and distributors of these substances:

Manufacturers and importers with registration obligations have to collect data on physical chemical, toxicological and eco toxicological properties as part of the registration process. The quantity and nature of the data that needs to be collected depends on the production or import volume, the nature of the substance involved, its intended use and the resulting expecetd exposure of people and environment to those substances.

Downstream users and distributors have an obligation to communicate the information they have on use and exposure risks to their suppliers (producers/importers) and must take actions in implementing risk reduction measures communicated to them by their suppliers. In addition they have an obligation to pass safety information on risks to health and environment to their downstream customers.

Companies can have different roles, depending on the types of substances they use and the stage in the life cycle of the substances. A company can be a manufacturer or importer of one chemical, and a downstream user for another. Companies sometimes even have dual roles...

REACH is about substances
REACH is about substances physically manufactured in the EU (plus Norway, Liechtenstein & Iceland) or brought into it. REACH requires that all substances put on the EU market need to be registered, save some exemptions. Where deemed necessary, substances will be Evaluated, Authorized or Restricted: eligible substances that are not registered will not be allowed on the market.
As a result, substances will disappear from the market or will be restricted in their use. 

Typical for base-oils/lubricants is that they are a mixture of substances (under REACH these are called “preparations”). In order to be able to continue to sell these preparations into the EU it is necessary to ensure all substances in the preparation are registered. When products contain hazardous substances, it is necessary to take into account the possibility that over time important components in the mixture will disappear from the market. This way REACH can have a direct impact on the performance and marketability of base oil trade products.

What does REACH mean for (global) traders of lubricants & additives?
As a buyer of an additive or a base-oil from a EU supplier, you don't have to register the respective substances. Your supplier has that responsibility. You do need to ensure that your intended uses for the substances purchased are covered by the registration of your supplier. This includes the uses of subsequent users downstream.

Downstream users have an interest in collaborating with their suppliers to ensure that their uses are covered in the registration. Depending on the diversity of uses within the industry sector, this can be more than a trivial exercise. A system of use descriptors has been prescribed to standardize this communication.

Non-EU suppliers exporting products to the EU have to take care that the substances in the products they trade are registered under REACH . No registration means no market, also for them.

Registration can only be done by a EU based entity! Non EU entities can assign an Only Representative to complete the registration. This relieves their importers from this burden but it also helps with ensuring that confidential business information remains that way: confidential. It simplifies the supply of information needed to complete the technical and safety dossiers required for registration.

To protect their business in the EU, suppliers may wish to assist their EU based registrant with his registration by providing information needed for the dossier (e.g. toxicological or environmental information, as well as safety data).
In comparison to producers, traders of products always have an additional challenge of obtaining the product data needed for the registration.

When a chemical substance is brought into the EU, and the importer is not contractually defined, the buying/purchasing company that brings the substance into the EU is most likely to become the importer under REACH. The company where the goods are delivered can become the importer under REACH. Ultimately the importer under REACH needs to register.

In general, products made up of substances that have been registered under REACH should be more valuable since they can be traded without further obligations into the EU. 

When doing business in the EU, being “REACH compliant” provides a company a competitive advantage versus companies that are not. This requires having a good understanding of REACH and all the obligations that follow from the different roles a company can have. 

For more information on REACH and direct access to REACH experts, please visit the REACH ExpertDesk at www.reachexpertdesk.com.