Changes ahead: Navigating new rules for product families and mixtures
In the last decade, the chemicals legislation of the European Union has become a highly sophisticated machinery. Manufacturing, importing, using and marketing chemical products requires a lot of knowledge and strategic planning. Companies need to allocate adequate resources for this task. It comes as no surprise that many struggle with this process, regardless of their size or sector.
Many CEOs thought that after the last REACH registration deadline, the tick-box for chemicals legislation could be marked as ‘done’. Today, most of them recognise this as wishful thinking. The realisation that chemicals compliance is a constant process was painful for many companies, and many are not even there yet.
Just like chemicals in general, biocidal products (BPs) are a constant focus for authorities that are sometimes too keen. One could get the impression that we are only living for chemicals legislation. Let's hope that we will soon change our approach and steer clear of a mountain of bureaucracy. Meanwhile, companies need to take care of compliance, and two relevant elements here are biocidal product families (BPF) and the CLP mixture notification (PC notification). Both areas are undergoing changes that will have a significant impact on biocides companies.
The BPF concept, as it stands in the BPR today, was originally introduced to give companies more flexibility in grouping individual BPs to a family, thereby saving money and time. The BPF concept is also designed to help SMEs to survive with legislation that is a major challenge for them in terms of bureaucracy. Indeed, the BPF concept proves to be a very useful and flexible tool. Actually, it proved to be too flexible for the evaluating authorities when they began evaluating the first BPF dossiers under the BPR. They were overwhelmed by very large dossiers, which covered a couple of hundred individual BPs. It was time to act; authorities asked for a change of rules by issuing additional guidelines for a ‘new approach’.
The new approach is less flexible. However, it will give a much clearer and more harmonised guidance on what is ‘similar’. Basically, the new guidance on BPFs will set distinct limits which will define whether an individual BP can be a member of a given BPF. While disagreements between applicants and authorities will probably be reduced, both the documentation and the setup of a BPF will become notably more burdensome and detailed. In practice, the new guidance will give more legal clarity, which is important for planning investments, while on the other hand it will limit the growing creativity in exploiting the flexibility of the BPF concept, something that has become important for reducing the administrative and financial burden. This guidance will no doubt be the most important set of rules for BPF applicants from now on.
The PC notification has the purpose of collecting data about mixtures, which is relevant for poison control centres (PCCs). This information should support PCCs in their everyday work to help people who have had accidents with chemicals. This system is not new in the EU, but the harmonisation of the data that needs to be submitted is. This harmonisation is based on Article 45 of the CLP Regulation. Based on this article, a new Annex VIII was added to the CLP Regulation. The requirements under the new Annex will enter into force in several steps, starting on 1 January 2020.
So that’s the theory. Practically, a lot of work still needs to be done and time is running short. Industry has already clearly stated that it currently doesn’t see itself in a position to implement the new obligations. A number of member states have similar concerns. But what is the problem? Well, there are actually several. The largest relates to a number of open legal questions. Some of these questions will eventually trigger the need for a legislative change of Annex VIII.
Navigating in such a framework of legal uncertainty is a huge challenge for every company. Where am I heading? What rules can I rely on? What can I do now, without risking that my investments will be lost because of some future changes? These are all questions that many companies that place mixtures – including many BPs – on the market are asking themselves today. And not everything can be answered satisfactorily yet.
In my presentation at the Biocides Symposium in Rome I will be touching on both of these areas. I will be giving an update of the recent developments and discuss with participants how to proceed and what to expect. Looking forward to seeing you there!
Places are still available at this year’s Biocides Symposium, taking place in Rome on 23-24 May. Click here or on the banner below to find out more and book your place.