Far-REACHing Chemical Regulations


As corny as my wordplay is, the meaning is real. After a lengthy and difficult period of negotiations, the European Commission and Council reached agreement about the final wording of the REACH (“Registration, Evaluation, and Authorization of Chemicals”) regulation. This draft was accepted by the European Parliament last Wednesday, and the regulation will be effective June 1, 2007. 

Essentially, the legislation requires manufactures and importers of chemicals in(to) the EU to submit information regarding the potential health and environmental impacts of their chemicals. 

What does it mean?  Well, to me, this sounds like a lot of work (it is), and as a consultant it tends to make me happy. Thinking as one of my clients, my first reaction is to think two things: (1) It only applies to chemicals, and (2) Probably I can use information developed by others.  Unfortunately, my thinking (except for the making the consultants happy part) would be wrong. 

REACH is a whole new approach to legislating product responsibility. Until now, tens of thousands of chemicals that had been “grandfathered in,” meaning that they had been on the market for a long time before legislation came, had been exempted from registration (this is true in the US as well as in Europe). This is how we ended up with lots of data on a relatively small number of “newer” chemicals, and very little data on the majority of “older” chemicals that are out there in our world. The REACH legislation aims to level the playing field: It obligates manufacturers and importers of all chemicals, regardless whether they are new or old, or whether they are alone, in mixtures, in products or in articles, to (1) Provide data and (2) Make an assessment of each anticipated downstream exposure scenario (i.e., each user/customer), and recommend protective risk management measures as needed.

Back to my first reactions:

It Only Applies to Chemicals
It is easy to think of REACH as a chemicals-based regulation, which, of course, it is. However, this leads some to believe—understandably, really—that REACH will not affect formulated products (mixtures) or manufactured articles. This is not so. Formulated products, or—to use REACH terminology—preparations, consist of chemicals, which are regulated. Articles, on the other hand, may incorporate hazardous chemicals (mercury in some LCD televisions), and some of them may be designed to release chemicals–for example, a printer cartridge or an air freshener. The chemicals in the preparations and the chemicals in the articles are subject to REACH, and depending on their identity and how much is being imported/manufactured in(to) the EU they may require notification or registration or both.

We Can Rely on Information Developed by Others
This is not true: The responsibility for compliance lies with the individual company. The regulation does not allow the use of generic information. Today, most Material Safety Data Sheets (MSDS) are pretty generic and, honestly provide little specific guidance (“dispose of in accordance with regulatory requirements” is a standard term). 

The fact that Chemical X has already been registered by another company does not waive your company’s obligation to register the volume of Chemical X that it imports. Under REACH, each manufacturer or importer is obligated to register the chemicals that it manufactures or imports.

The new regulation requires registration for chemicals that are manufactured or imported in quantities of more than 1 metric tonne per year (mtpy).  For chemicals manufactured or imported in quantities of more than 10 mtpy, REACH requires each manufacturer or importer to author a Chemical Safety Report, including an e-SDS, for the chemical. 

What is an e-SDS? It is an “extended” Safety Data Sheet, which is the Material Safety Data Sheet (MSDS) as we know it, supplemented with Exposure Scenarios and Risk Management Measures for the so-called Identified Uses. The e-SDS must address all Exposure Scenarios for the chemical, involving workers and the environment, at the point of manufacture and at all Downstream Users’ facilities (customers, your customers’ customers, and so on, all the way down the supply chain). The e-SDS also needs to recommend the appropriate risk management measures for each of those exposure scenarios. 

Some examples:
• Your company imports chemicals into the EU. If your company imports more than 1 metric tonne per year (mtpy), then your company must register the chemical… If your company imports more than 10 mtpy, your company must author a Chemical Safety Report including an e-SDS for the chemical.

• Your company imports a product into the EU, and the product contains Chemicals X,Y and Z. If the imported volumes of Chemicals X, Y and Z amount to more than 1 metric tonne per year (mtpy) each, then your company must register all three chemicals.

• Substances that are contained in articles and that are subject to authorization must be notified to the authorities, who will review the notification and may request a registration depending on the outcome of this review.

• In addition, chemicals that are released from articles—as a result of how they are used, or incidentally—and that are imported, as part of these articles, at more than 1 mtpy, require registration.

Many thought that REACH would be delayed because of the very difficult negotiations that were going on, between the Commission and the Council, until the end of last week.  Until last week, many companies were reluctant to commit to compliance programs, as there was no certainty regarding the final details of the regulation. That certainty is now here, and the time to act is now, as the most direct impact of non-compliance will be the inability to manufacture or import products in(to) the EU in the future. 

Indirect effects can be equally devastating. For example, consider the impact of no longer being able to buy a certain product or chemical that you’ve been relying on for your business, because it’s no longer on the market in the EU.
Bottom line, if your company is part of a supply chain that involves chemicals (either on their own or in mixtures or in articles) and that intersects with the EU at any point along that chain, you need to develop a compliance program to: 1) Protect your company’s ability to continue to manufacture or import in(to) the EU, and 2) Avoid supply chain disruptions. The first tasks at hand are to understand your supply chains very well, and to prepare for pre-registration (in 2008) of the chemicals that are important to your business.

As with all regulations, they seem more ominous when they are new. If any of this applies to your business, get some advice, and get going, the lines are forming and the knowledgeable advisors are few.