Yes. The CMC 1 Point 2 REACH + obligations do impose some possible difficulties in the usage of technical additives in EU fertilising products. Typical additives that are used in the market such as colourants are produced in very small quantities and thus not registered. Another issue is preservatives. Some preservatives are also incorporated into fertilising products which are also already approved under the Biocidal Products Regulation (BPR).
The basic principle in the BPR is that a biocidal product must be authorised before it can be made available on the market or used in the EU.
This takes place in two consecutive steps. First, the active substance is evaluated and, provided the criteria are fulfilled, is then approved for a specified product-type.
The second step is the authorisation of each product consisting of, containing or generating the approved active substance(s). In order to approve an active substance, its hazardous properties and possible risks to humans, animals and the environment are thoroughly assessed. To avoid duplications, such active substances manufactured or imported for use in biocidal products only are considered as being REACH registered, according to Article 15(2) of REACH Regulation.
This concerns both active substances approved (including for use in product-type 6 – preservatives for products during storage), as well as substances listed in Annex II to Regulation 1062/2014 as being under assessment in the programme of review of existing biocidal active substances.
Some fertilising products, especially those in liquid form, may include a biocidal products (mixtures or substances) used as a preservative agent during storage.
For the purpose of the FPR, these mixtures or these substances may belong to CMC 1.
In such a case, the active substances in these biocidal products are regarded as being registered in REACH exclusively for this use and the requirement in point 2 in CMC 1 is considered as fulfilled, and no REACH registration of the active substance(s) is necessary for the purpose of fulfilling the criteria of CMC 1.
- From the EU FPR 2019/1009 FAQ - question 8.14 - emphasis added
Was this article helpful?
That’s Great!
Thank you for your feedback
Sorry! We couldn't be helpful
Thank you for your feedback
Feedback sent
We appreciate your effort and will try to fix the article