Just as the manufacturers of the world thought they were getting a stranglehold on the compliance requirements in the European Union (EU), the EU throws in another regulation to comply with. On June 1, 2007, the Registration, Evaluation and Authorization of Chemicals Regulation (EC 1907/2006), more commonly known as REACH, came into force. The REACH Regulation was created with the intention to protect human health, as well as the environment, by reducing the risk of harmful chemical exposure.

At first glance, most (if not all) companies construe the REACH Regulation to only apply to chemicals and chemical-based products such as detergents, oils, and lubricants, etc. However, this is not true. REACH includes a very important section that pertains to all manufacturers of articles. According to REACH, Article 3 (3), an article can be defined as the following:

“…an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition.”

Examples of articles include a smoke detector, MP3 player, computer, wet wipe, etc. The REACH Regulation requires manufacturers to register substances that are intentionally released from their products and to notify the European Chemical Agency (ECHA) of any Substances of Very High Concern (SVHC) that are present in the article being placed on the EU market. Manufacturers need to be aware of requirements associated with SVHCs, as it will require as much effort in data collection and assessment for producers of articles, as put forth by the chemical producers.

Defining SVHCs

Enlarge this picture Fig. 1. Timeline for REACH regulation.

The next logical question is what exactly constitutes an SVHC. Annex XIV of the REACH Regulation is to contain a candidate list of the substances that the EU has deemed to be SVHCs. However, that list does not yet exist – it is expected to be created and augmented in consultation with EU Member States as the hazardous nature of certain chemicals are identified throughout the REACH registration process. The first 16 proposed substances for the candidate list have been disclosed by the European Chemicals Agency (ECHA), but the first installment of the SVHC candidate list is not expected to be published and made official until spring 2009. Recently, the ECHA has added two of the candidate substances (Alkanes, C10-13, chloro (short chained chlorinated paraffins and bis (tributyltin) oxide) to Annex XIV because of the lack responses surrounding these two particular substances. Are these 16 the only ones that companies have to worry about in the short term? Not necessarily. The ECHA may choose to add other priority substances based on associated hazards and volume of sales prior to publication.

It is commonly understood across many industries that the candidate list will be comprised of substances designated as Carcinogenic, Mutagenic, and Reproductive Toxins (CMRs), Persistent, Bioaccumulative and Toxic (PBTs), and very Persistent very Bioaccumulative (vPvB) substances. The SVHC list of substances is expected to include thousands of substances. In fact, lists of substances expected to someday belong to the SVHC list have been generated and published by both the automotive and aerospace industries in Europe and contain more than 1,000 substances they are recommending that their members avoid, restrict and/or eliminate from their products.

There are immediate and long term expectations for substances declared SVHCs. As mentioned previously, communication and notification of the presence and use of the SVHC will be required to reduce health and environmental risks posed by the presence of the SVHC. In the future, the ECHA will require that manufacturers or importers of articles containing SVHCs seek authorization for continued use of the SVHC in their products. Ultimately, the ECHA may restrict or outright ban the use of the SVHC in specific applications. If a company’s product contains an SVHC, it is a good idea for it to seek alternatives and create a substitution plan well in advance of action by the ECHA.

Mandate and timeline

The REACH Regulation has made it mandatory for producers or importers of articles to register the substance with the ECHA if that substance meets the following criteria:

• The substance is intended to be released through the normal or foreseeable use of the product.
• The substance in the article exceeds 1 tonne per year per producer or importer.
• The particular substance is not currently registered for that particular use with the ECHA.
• For articles that contain SVHCs the producer or importer is required to notify the ECHA of the presence of SVHCs. This notification follows a distinct process from that of registration. The circumstances under which the producer or importer is required to notify the ECHA of an SVHC are as follows:
• The SVHC present in the article exceeds a concentration of 0.1 percent by weight of the article.
• The substance in the article exceeds 1 tonne per year per producer or importer.

Where the substance exceeds the 0.1 percent by weight criterion, the producer or importer is to communicate the presence of the SVHC to downstream users and provide safety handling guidelines. If, however, a producer or importer can prove that humans or the environment are not exposed to the SVHC through normal or foreseeable use including disposal of the article, they are not required to notify the ECHA of the SVHCs in the article.

Substance registration

The REACH Regulation has two categories of substances that require registration:

• Non-phase in substances: These substances have not been manufactured or placed on the EU market prior to the REACH Regulation being put into force.
• Phase in substances: These are substances that are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) or chemicals that have been produced in the EU but have not been placed on the market in the EU since 1992.

A non-phase in substance must be registered with the ECHA before it can be placed on the market in the EU. As the registration requirements are rather stringent and comprehensive, the registration process can be costly to companies – estimated to cost between € 2.8 billion and € 5.2 billion total, and some have even argued that the REACH Regulation is actually a barrier to trade. The EU has rebutted those accusations with the allowance of consortia or Substances Information Exchange Fora (SIEF) for data sharing (for those importers/producers who have taken advantage of pre-registration), Only-Representative agreements for foreign producers and other potential cost-saving tools. The verdict is still out as to how much money the provided tools from the EU will actually save the downstream users.

Phase-in substances have a more lenient timeframe for registration as compared to the non-phase in substances. These substances have three different registration periods based on the annual sales tonnage.

A. Pre-registration – June 1, 2008 to December 1, 2008.
1. Phase-in substances can be pre-registered which allows the importer/producer to take advantage of the extended registration periods (detailed below).

B. 3 1/2 years after REACH entered into force (Dec. 1, 2010).

1. Substances that exceed 1,000 ton per year per importer or producer.
2. Substances that exceed 1 ton per year that are deemed to be a CMR (both for category 1 and 2).
a. Category 1 CMRs: substances and preparations that are known to be CMR for humans.
b. Category 2 CMRs: substances and preparations for which human exposure to such substances and preparations is strongly suspected to cause or increase the frequency of appearance of CMR effects.
C. 6 years after REACH entered into force
(June 1, 2013).1. Substances that exceed 100 tonnes per year per importer or producer.
D. 11 years after REACH entered into force (June 1, 2018). 1. Substances that exceed 1 tonne per year per importer or producer.

Communication of the presence of each substance is not required until six months after the substance has been identified on an SVHC candidate list. The first notification will not be required until December 2011. This should allow producers or importers sufficient time to gather the required information in order to make the proper notification.

Implications

The reality of the REACH Regulation is that article manufacturers worldwide will receive requests from their downstream users to identify potential SVHCs that are present in their articles or products. Suppliers will be expected to provide information pertaining to all substances used in the production of their products/articles, including the disclosure of proprietary information. The producers/importers of articles placed on the market in the EU will need to obtain this information in order to comply with REACH registration and notification obligations.

Currently, industry leaders are taking a proactive approach to complying with the REACH Regulation, simply because of the complexity of the regulation. Due to the detailed information that is to be supplied to the ECHA, communication throughout the entire supply chain will be required to provide the proper registration and notification information. Where suppliers and downstream users were able to maintain business relationships with minimal communication and exchange of information on supplied materials, the REACH Regulation will simply not support the existence of those types of relationships.

It is expected that the first requests from producer/importers to their supply chain will be rather muddy. The majority of the companies outside the EU community are unprepared or unable to provide this type of information in a timely fashion. It may require them to communicate up and down their, sometimes multiple, supply chains to gather the required information. In today’s age of global supply chains and compliance requirements changing almost on a daily basis, manufacturers are quickly realizing that their supply chain is not as clean and proficient as they once thought. Over the years since the emergence of RoHS, horror stories have been related about companies discovering that their supply chain is simply supplying “compliant” statements in response to customer inquiry about their product, only to be found through compliance assurance activities that the opposite is true. In these cases, certainly some endorsements of compliance were misleading, but many were supplied as a result of lack of understanding of the requirements and the full extent of the declaration. So, to expect the importers’ and producers’ supply chain to be able to provide this type of information for the initial requests is going to be reaching.

Major brand owners who have gained invaluable experience from complying with previous directives such as the multiple RoHS directives, California Proposition 65, and other global restricted substance regulations, have decided to take a pro-active approach when dealing with REACH. Some of the larger companies that are mandated to take on registration right away, as they exceed the 1,000 tonnes per year criterion, have engaged in communication with their supply chain to gather the required information for immediate registration. This has proven to be useful, as it identifies not only where they themselves stand with providing product information, but also how efficient data gathering from suppliers will be.

In some cases, companies with a large number of products have contracted third parties to contact suppliers and work directly with them in order to facilitate the information gathering process as well as side-step any disclosure of proprietary information squalls. These proactive approaches increase the potential for seamless compliance and uninterrupted business with in the EU community.

In addition, industry organizations are also putting together guidance documents to help companies prepare for REACH. ASD-STAN, the European body for the development of aerospace standards has published two technical reports (TR9535 Substance Declaration and TR9536 Declarable Substances Recommended Practice) on chemicals and their safe use in context of the REACH Directive.

Conclusion

Article producers must realize that they will be affected by the REACH Regulation in some way, and will be required to provide substance information pertaining to their product. Due to the high level of complexity, and amount of information that is being requested, it is recommended to start communication up and down the supply chain to determine where suppliers and downstream users stand in terms of REACH and their ability to comply. This action will not only allow suppliers to comply with REACH with less effort in the future, but also reduce costs of potential testing for SVHCs in the event suppliers are unable or unwilling to provide information on SVHC content.

For more information, email: ageus@intertek.com or visit: www.intertek.com/reach