Deep Impact - Reach affects almost all departments in a chemical company. It is not only an issue for the regulatory affairs manager, but has an overall impact on procurement, production, distribution, sales and marketing. Customers, authorities and investors need to be assured that a company is compliant with the Reach legislation. TNO Triskelion advises that Reach compliance relates to your license to operate and therefore has to be a priority for management all the way up to board level.

‘We Buy, Transform and Sell Chemicals'

Manufacturers, formulators, distributors, downstream users and article users are all affected by Reach. In many companies, at least some people understand part of the effects of Reach. However, many internal Reach processes are only now being developed and not fully integrated. Hence our sketch of various situations that may occur:

Your purchasing department should consider a number of things. Questions may arise about the substance identity and composition. According to the European Chemicals Agency (ECHA), this is an issue for improvement in registrations in general. Does the substance fit the identity of the registered substance? Has the substance been registered at all?

You should be able to tell from the registration number. If the substance is bought from outside the EU, we advise to check whether an Only Representative (OR) for importers can cover your registration, too. Otherwise, you may be able to buy access to an existing dossier and act as a joint registrant. Several components may need to be registered for a chemical mixture from outside the EU. Chemists may provide relevant details on the composition.

Strictly Controlled?

Doing a chemical transformation implies that you use intermediates. We have seen many intermediates stated to be used under "strictly controlled conditions." Verification of these statements is a key issue in the ECHA work plan for 2012. Can your plant managers and environmental health and safety experts justify that the conditions are indeed strictly controlled?

Several companies we audited told us that a critical outsider helps to improve their justification. Intermediates not under strictly controlled conditions and other substances may come with exposure scenarios. An (external) audit helps to ensure that the use, operational conditions and risk management measures in the exposure scenarios cover your situation. These documents often contain jargon or criteria that do not facilitate easy checking against real world situations.

Strategic Business Decisions

What if the described use, conditions and risk management measures do not cover your situation? Strategic business decisions are needed. Do you stop this process (and stop selling the product)? Are the investments to modify process, conditions or measures worthwhile? Technical expertise and market knowledge are needed to make a business case.

In some cases, e.g. when you start a new production, you may have to consider registration now. Your annalists need to obtain relevant identifiers of the substance. Perhaps it fits the Reach definition of a polymer that does not require registration. Toxicologists should determine the classification of your chemical. If it is classified, exposure scenarios for manufacture and use throughout the life cycle are needed. Your EHS experts can develop these or work together with consultants.

Questions During Sales Process

A number of questions may pop up during the sales process of your product. Do you know the uses of your clients (and their clients)? Can your sales people obtain written assurance on strictly controlled conditions for intermediates? Is your substance of very high concern, and does it end up in an article? Your customer service may be able to help your clients with the resulting communication requirements.

When your sales see a promising new market, you have to check whether the new use is covered under the existing registration. One company wanted to sell off-specification materials. Our advice was to widen the scope of the substance definition for this material and refer to the existing chemical safety assessment, since safe use was still ensured. Keep in mind that Reach dossiers contain specifications of the products you manufacture and this may limit your options.

Communication Is Key

You should consider Reach implications throughout your business. Buy a product for a nice price in China? Consider registration requirements. Safe use recommendations from your supplier? These may be obligatory under Reach, just like your recommendations can be obligatory for your clients. Reach therefore requires substantial internal and external communication.

Purchase, sales and customer support departments are in the frontline. They communicate with suppliers and buyers. They should be able to discuss product identity and should be able to answer questions on the (extended) Safety Data Sheets that you provide with your product. They need sufficient Reach knowledge and proper communication with technical experts, production managers, EHS specialists, etc. When you start a new product or open a new market, communication is needed to create an economically sound business case and to gather use related information for your Reach dossier.

Because Reach communication affects many groups in your company, a strong internal communication structure is crucial. Good communication with suppliers and clients also helps.

Ownership And Responsibility

Why make such a fuss about Reach? Reach itself provides a clear and highly convincing business reason: "No data, no market." You may think your Reach work is ended by keeping the Phase I registration deadline on Dec.1, 2010. TNO Triskelion thinks this was only the beginning. Phases II and III are still to come and the follow-up for registered substances provides substantial responsibilities. Continued Reach compliance is a crucial part of your license to operate.

Pro-active compliance with Reach helps restore trust in chemicals and improves the chemical industry's reputation. Remember that people in Europe are not convinced that chemicals are safe. Even now, after Reach has been in progress for several years, 50 % of members of European Parliament stated in a Cefic survey that chemicals are unsafe and not properly tested. Widespread Reach compliance efforts will help to change that mindset.
Reach inspections by authorities can be expected. Be prepared for a smooth inspection. You should know the requirements.

You should be able to answer relevant questions, e.g. on issues mentioned earlier in this article. Proper documentation is very helpful to show due diligence. If you cannot convincingly show to be compliant, warnings or fines can be the result. In extreme cases the continuation of your business might be at stake.

Please keep in mind that Reach is not "just" a project for regulatory affairs managers. Reach compliance requires management ownership and responsibilities throughout the company. Good practice is to establish a Reach team under auspices of the general management with a strong manager and representatives from various departments. In this way Reach compliance can become a successful element of your business.