Advantages and Disadvantages of REACH Registration of Intermediates in EU

Release time:

2021-05-26 14:28

Compared with the registration of ordinary substances, the registration of special types of intermediates, especially pharmaceutical intermediates, can save time and cost. What are the regulations of EU REACH registration on intermediate registration? How should enterprises deal with EU intermediate REACH registration? What should be paid attention to when doing EU intermediate REACH registration?

Definition of intermediate

The definition of intermediate in the REACH Regulation: a substance that is manufactured, consumed and used in a chemical process that converts one substance into another.

Intermediates are classified under REACH into the following categories:

Non-isolated intermediates:

Intermediates that are not intended to be removed from the synthesis reaction generator during the synthesis (except for sampling). Such equipment includes reactors, auxiliary equipment, piping equipment for the transfer of substances between reactors for the next reaction and other equipment for the continuous or intermittent passage of substances, but does not include storage containers after preparation of new substances.

Isolated intermediate:

1. On-site isolation of intermediates: intermediates that do not meet the criteria for non-isolated intermediates, the manufacture of which and the synthesis of other substances from the intermediates take place at the same location, and the process is operated by one or more legal entities.

2. Transferable isolated intermediates: refers to intermediates that do not meet the criteria for non-isolated intermediates and can be transported or provided between other locations.

The use of non-isolated intermediates is not covered by REACH regulations. Although on-site isolated intermediates are within the management scope of REACH regulations, they are mainly aimed at EU local enterprises by definition. Intermediates that can be exported to EU by non-EU enterprises must be transferable isolated intermediates (transported isolated intermediate).

Special provisions for the registration of intermediates

Enterprises/importers with annual exports/imports of more than 1 ton of transferable intermediates are obliged to complete the registration under the REACH regulation. However, compared with general-purpose substances, the REACH regulations (Article 18(2) and relevant provisions on the registration of transferable isolated intermediates) of strictly controllable (SCC) intermediates stipulate that the registration of intermediates can be partially exempted (for example, CSR does not need to be developed), which reduces the data cost. In addition, ECHA also has a great discount on the administrative fee of intermediates, as a result, the cost of registration by intermediate use is often only a fraction of that of registration by ordinary substances. Specifically:

1) ECHA registration administrative fee: joint 1200 euros; separate 1600 euros.

2) No need to develop a Chemical Safety Report (CSR) for all tonnages.

3) Intermediate registration data of more than 1000 tons requires only the preparation of data of 1-10 tons/year of common substances, and SCC intermediates of less than 1000 tons/year, only the submission of existing data can meet the registration conditions. However, it should be noted that the above registration benefits only apply to intermediates that meet the production and use conditions under "strict control conditions. If this condition is not met, it must be registered as an ordinary substance. It should be noted that polymer monomers (monomer) cannot enjoy the treatment of intermediate registration, and registration files must be prepared according to ordinary substance use.

Considerations for intermediate registration

Intermediate registration has many advantages, reduce registration costs, shorten the registration time, so many enterprises hope to do REACH registration through intermediate channels, but everything has advantages and disadvantages, intermediate registration also has a lot of attention.

First of all, it is necessary to clarify the use of the substance after the import of downstream users, that is, to determine that the substance meets the definition of an intermediate. This is a prerequisite for confirming the strict control conditions in the second step, and also to confirm whether it can participate in the joint registration of substances specified by LR for specific uses.

Secondly, only in the premise of confirming the use of intermediates to investigate whether it meets the strict control conditions have practical significance. At present, REACH regulations do not have quantitative requirements for strict control conditions, but only require that the material can be strictly controlled during the complete life cycle to prevent and minimize the harm to humans and the environment, and provide supporting documents.

3. If an enterprise conceals the actual use situation and forcibly registers according to the intermediate use, it may face the risk of limited trading objects and REACH regulations, that is, EU importers will not be able to use the REACH registration number to import the goods of the registered enterprise, and the enterprise will face the embarrassing situation of not being able to use the registration number. If so, the enterprise's early REACH response investment will be wasted.

The above is the whole content of our intermediate REACH registration special article in this issue. If you have any questions, please contact us.

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