Roles Under REACh (Part 3)
After eight years, companies still struggle with implementation
Regulation (EC) No. 1907/2006 of the European Parliament and of the Council, well-known as the REACh regulation, or Registration, Evaluation, Authorization and Restriction of Chemicals, was published on Dec. 18, 2006, and went into effect June 1, 2007. Since then, REACh has kept people busy - from the industry, to the European Chemicals Agency (ECHA), to national authorities, consultants, lawyers, labs and other service providers.
Starting with the preregistration period until 2008 companies feared they would not be able to meet the first deadline for the registration of substances in the highest tonnage band, as well as substances with certain properties (R50/53, CMR) in lower tonnage bands in 2010. A large number of data requirements had to be fulfilled. Companies willing to register the same substance had to be brought together; consortia had to start their work with the aim to submit the registration dossiers in due time. Although timelines were tight and most dossiers were submitted in the nick of time, companies somehow managed to fulfill their registration obligations toward the first deadline. In the meantime, the second deadline for the tonnage band from 100 to 1,000 tons per annum (t/a) in 2013 passed, and industry at the moment is aiming to get things in place for the final 2018 deadline.
Companies that have to deal with REACh have relationships not only with authorities but also with competitors and actors in the supply chain. The number of interfaces (see figure) is directly connected to the number of problems and resulting tasks that may occur in daily business.
Communication Up and Down Supply Chain
REACh matters are not restricted to the cooperation with competitors within consortia, but there are also a large number of obligations in regard to communication up and down the supply chain.
Communication With Suppliers
European companies that purchase substances may benefit from being Downstream Users when they buy from European sources. If they buy from non-European sources, first they must check whether their non-EU supplier takes care of registration obligations via an Only Representative. If so, the situation will be equal to that when they buy from European sources.
If a non-European supplier does not take care of the registration obligations under REACh, the European company will have to take the role of an importer. The situation may become a challenge if the European company did not preregister the requested substance and it is no longer allowed to do a late preregistration. In cases where no second supplier in Europe is available in the short term, the European company may have to postpone a new project or - even worse - lose a customer. Therefore it is recommended that European companies take care of such issues as soon as possible.
If the European company is a Downstream User, it will benefit from not having registration obligations on its own, but there are still some other obligations that have to be fulfilled by a Downstream User.
Downstream Users have the obligation to check whether the identified uses that are covered with the registration of each supplier also will cover the uses of their companies. If the supplier did a registration for a transported isolated intermediate only, Downstream Users will have to agree on that by signing a confirmation that they will use the substance for the synthesis of another substance by abiding by strictly controlled conditions as demanded by Article 18(4) of the REACh regulation ("Article 18(4) confirmation").
If the supplier did a standard registration, the Downstream User has the obligation to compare the identified uses with the own uses and to compare with the exposure scenarios attached as an annex to the safety data sheet issued by the supplier. This comparison very often is extremely time-consuming. If the uses of the Downstream User are not covered, further communication with the supplier is required. The Downstream User has to provide the supplier with detailed information in regard to the intended uses and corresponding exposure scenarios to make them identified uses. Afterward it is up to the supplier whether it is willing to update the registration dossier or it will categorize a certain use as a "use advised against." Again there is a certain risk that the supply with a certain substance may be interrupted and therefore will bear a business risk for the Downstream User, because it will need some time to take further action (e.g., create a Downstream User report).
Communication With Customers
First, a manufacturer of chemical substances has the obligation to pass on information on the hazards of a substance to the customers by providing a safety data sheet. In some cases there is also an obligation to attach an annex including exposure scenarios that are covered within a registration dossier for a certain substance. If a substance is registered as a transported isolated intermediate only, the registrant will ask at least all European customers for an Article 18(4) confirmation.
If the uses of the customer are covered, there is no further communication needed from the customer to the supplier. In all other cases, discussions will be started as already mentioned in this article.
Very often in daily business, communication is initiated by requests from customers or potential customers. They may even send questionnaires comprising several pages that a supplier is urged to fill in to keep business running. This can be very time-consuming and in some cases even expensive. Customers who buy articles have the right to ask their supplier about the content of substances of very high concern (SVHC) in the article. If such an article comprises numerous components, it is highly likely to be impossible to answer the question in regard to the SVHC without having a high workload. The question may be answered when the supplier of an article asks all suppliers of each single component about their statement in regard to SVHC. Alternatively it might need less effort to ask a lab to cut the requested article into small pieces and afterwards pulverize with the aim to analyze the powder for SVHC.
Processes To Achieve REACh Compliance
Substance Volume Tracking
Within a company it is necessary to do Substance Volume Tracking at least once per calendar year. If the tonnage band of an already registered substance needs to be amended (usually based on the average of the three previous consecutive calendar years), the registrant needs to do an update of the registration.
European manufacturers that sell the manufactured substances solely under the purpose and scope of REACh can easily do Substance Volume Tracking. The task becomes more difficult, if parts of the manufactured volumes are exempted from REACh, e.g., biocides.
The situation is even worse in the case of Non-EU Manufacturers that have to split up the amounts that are delivered to European customers and other customers per calendar year. It is a demand that an Only Representative acting on behalf of a Non-EU Manufacturer needs to know at any time the volumes that were imported under REACh into the European Economic Area (EEA) in a certain calendar year. That means a Non-EU Manufacturer who registered a certain substance via an Only Representative needs to know not only which volumes of a certain substance went into the EEA, but also needs to split it into use under REACh and use as a biocide, etc.
In the past there were a lot of discussions in regard to the question whether indirect imports may be covered by the registration that was done by an Only Representative on behalf of a Non-EU Manufacturer. Maybe a Non-EU Manufacturer registered via Only Representative in the highest tonnage band and afterward sells the substance to EU customers, non-EU customers and maybe to non-EU traders. If the non-EU traders intend to sell such a substance to EU customers it is not possible to respect the competition law and at the same time provide the Only Representative with the information about volumes and the first party within EU that receives the substance; therefore, it is highly recommended that Non-EU Manufacturers do not provide registered substances to non-EU customers.
Dr. Susanne Kamptmann