Health and Safety Executive

Company producing biocidal and plant protection products clarifies their status under REACH

REACH case study

Key messages

  • Active substances in Biocidal and Plant Protection products are exempt from registration, but are still under scope of REACH.
  • Companies will have to join SIEFs
  • The data provided under the Biocidal and Plant Protection Products Directives will have to be shared within these SIEFs.

Bloxford Speciality Chemicals produce insecticidal products for use both as Biocides and Plant Protection Products. They manufacture the active substance used in all these products on site and formulate the products for sale. As they are a large manufacturing company, they have a regulatory manager, Laura, who is familiar with the Biocidal Products Directive (BPD) and the Plant Protection Products Directive (PPPD)

Laura has put together an extensive data package on the active substance which has gone through the evaluation process under PPPD and is on Annex I of that Directive. It has also been notified in Product Type 18 (Insecticides) of the BPD and is currently under review. Bloxford have therefore complied with all their requirements under both these sets of EU legislation. Laura is also aware of REACH and has spent some time researching on the internet how this legislation will affect Bloxford. She has found out that active substances used in Biocidal and Plant Protection products are regarded as registered under REACH and so she does not have to register (or pre-register) this substance.

A number of Bloxford’s competitors manufacture the active substance at quantities of greater than 1 tonne per annum, but only use it in degreasing products. Laura had anticipated that these companies would pre-register this substance and therefore a Substance Information Exchange Forum (SIEF) would be established.  Laura realised that, although Boxford have no requirement to pre-register the substance, because they own an extensive data package on the substance relating to BPD and PPPD,  they are required to work with the companies in the SIEF. As REACH does not allow for an animal test to be conducted if one already exists, Laura has anticipated that her company would be required to share the data they own with the other companies in the SIEF. She has identified what data are required under REACH at the different tonnage bands and has produced a list of the relevant data Bloxford own. She is now in the process of estimating the value of each study, so they are in a position to be able to share the costs of the data with company’s in the SIEF.

Additionally, Laura had noted that the exemption for the active substances does not apply to the none active components within the formulations Bloxford manufacture. She has compiled an inventory of these substances and pre-registered them prior to the deadline of 1st December 2008 where appropriate.

Relevant REACH articles

  • Substances in plant protection products and biocides - Article 15
  • Duties of the commission, the agency and registrants of substances regarding as being registered - Article 16
  • Substance Information Exchange Fora - Article 29
  • Sharing of data involving tests - Article 30

Directgov - Business Link

Updated 30.03.11