Foreward
The Biocidal Products Directive n. 98/8/EC (also known as the BPD) entered into force on 14th May 2000 and was the first EU wide scheme under which biocides (active substances and products) were regulated and assessed for their safety to people, animals and the environment. The BPD introduced for the first time the concept of the mutual recognition of authorisations within the Community. A fundamental aim of the BPD was to establish a positive list of actives substance which may be used in biocidal products. Once a biocidal product was authorized under the Directive in one EU Member State, authorization could then be easely granted in all other Member States.
Since the BPD was written as a ‘Directive’, each EU Member State was then responsible for implementing the BPD into their national law. This caused some discrepancies between Member States within the first year of application.
Annex I of the BPD contained all the biocidal active substances that had been assessed and approved for use in biocidal products. The ultimate target of companies submitting active substance BPD dossiers was to gain ‘Annex I inclusion’.
The biocides review program under the BPD Biocidal active substances which were on the market before the BPD entered into force (14th May 2000) were referred to as “existing active substances”. New biocidal active substances are those which were not on the EU market prior to the 14th May 2000. New active substances need to be assessed and approved before biocidal products containing them can be placed on the EU market. From the date of entry into force, it was optimistically expected that the BPD review program would last for 10 years and that by 2010 all the existing biocidal actives would have been approved. When it became obvious that this was not possible, the deadline was extended to 14th May 2014. Under the BPR, the deadline to approve all actives was then extended even further to 31st December 2024. By the end of 2023 45% of the review program was completed, so it is clear that the deadline of 31st December 2024 will not be achieved. The proposal of the commission is to extend the review program until the 31st December 2030. The delegated act amending BPR has not yet been published. The review program for existing active substances was governed by many additional EU Commission review regulations and guidelines.
The Biocidal Product Regulation (BPR)
In 2012, the long-awaited Biocide Product Regulation (BPR) was, in the end, published as EU n. 528/2012.
The equivalent Annex I under the BPR is referred to as the ‘Union list of approved active substances’ but it’s important not to confuse Annex I of the BPD with Annex I of the BPR. Annex I of the BPR refers to the list of active substances that can be used in products eligible for the ‘simplified authorization procedure’.
Manufactures/importers (suppliers) of biocidal active substances that are not involved in the approval process, must either submit an application for review of a novel active substance or participate in the existing active substance procedure by applying for inclusion on the Art. 95 list. In first case, the biocidal product can only be placed on the market after the Commission decision on the active substance, in the second case, the BPR provides for a transitional arrangement that grants biocidal products marketability at least until the decision on the inclusion of the existing active substance has been taken. After approval of a given active substance at EU level, all biocidal products containing such a substance are subject to authorization. Furthermore, BPR explicitly defines treated articles, “in situ” generated actives setting specific provision for all these. Furthermore, it changed consistently the definition of “product family” which comes from the old “frame formulation“ definition in BPD.
The BPR confirmed that a product authorization can be done by different procedures: first authorization in a selected Member State, mutual recognitions procedure, same biocide approach, family approach and Union Authorization (when multiple national markets are of interest).
In any case, with the application of BPR, authorization processes became more difficult for many reasons.
Firstly, but not only, many guidelines regarding the testing phases, all along the years, were updated or released as new and became more stringent. In particular, the efficacy tests changed in some way the study protocols and the thresholds to get a product efficacious decreased. On the other way, but not less impacting, the safety classification of a biocide product became more demanding. The evaluation of the SOCs (Substances of Concern) and of EDCs (Endocrine Disrupting Chemicals) were introduce in recent years leading to a difficult to avoid critical safety classification of the biocide product. In such cases, the given product is no longer considered safe and not allowed to be marketed.
From an administrative point of view, the BPR introduced a new informatic system called R4BP (a sort of central hub) through which all biocide’s application are submitted to Competent Authorities (ECHA and/or Nationals) allowing the exchange of information between the submitting companies and these authorities. IUCLID (International Uniform Chemical Information Database), the old system, was once more updated and again adapted for biocides submission. The preparation of a PAR (Product Assessment Report) is now required as integral part of an authorization dossier.
Increasing complexity leads to workability issues
Increasingly and complex rules lead to a much more severe attitude of the Competent Authorities both at National and Central level (ECHA); as an example, we can mention that the family approach (which include a number of products together) proposed by the submitting company is always subjected to a pre-submission meeting with technical people from CA. It is known that the family approach proposed is often not welcome by CA and a further re-setting of the approach and a new discussion is needed. Often, this leads to a rejection of the authorization. This is a very time-consuming and frustrating activity for all.
Hence, it is easy to understand that the authorization of a biocidal products has become a very difficult procedure for EU companies particularly for SMEs (Small Medium Enterprises). In general, workability of BPR started to decrease!
On 23 February 2015, the European Commission released a number of so-called Practical Guidelines within the context of the BPR, among which is the document entitled “Practical Guide on Consortia under the Biocidal Products Regulation No 528/2012”.
The document explains, e.g., the novel concepts of “biocidal product family” (BPF) and “same biocidal product” (SBP) introduced in the BPR aimed at facilitating the process of applying for product authorizations for companies (such as SMEs) and reducing cost and administration issues involved. Both the BPF and SBP encourage the coming together of like-minded companies to jointly develop a dossier and to make a joint application for authorization of a BPF (which can be held by the consortium or a leading member), on the basis of which the products of individual companies could be authorized under the BPF, or individual companies could subsequently apply for own product authorizations (for example as a SBP).
From that year (2015) we all have seen the setting up of a number of Consortia/Task Forces mainly between small and medium companies (producers, formulators, distributors, importers) trying to help each other to reach a fruitful authorization of their biocide products at an acceptable cost level.
SMEs and BPR: what’s the issue
Small-Medium Enterprises are well spread all long the European Union and mainly in such specific Member States like Italy, Spain and Greece. They are supporting the EU GDP (Gross Domestic Product expressed as “the standard measure of the value added created through the production of goods and services in a country/area during a certain period) is a relevant way. SMEs are considered the backbone of Europe’s economy as they represent 99% of all businesses in the EU. They employ around 100 million people, account for more than half of Europe’s GDP and play a key role in adding value in every sector of the economy. Therefore, they are essential to Europe’s competitiveness and prosperity, industrial ecosystems, economic and technological sovereignty, and resilience to external shocks, experts said.
Nevertheless, it’s seems that this crucial economic asset was not/is not taken into much consideration by EU regulators when thinking about new EU rules; everything seems done not to support EU SMEs development and/or survival. What are the difficulties they encounter every day when facing regulatory challenges (not only in the biocides world)? Let’s see.
- They are family owned and often very….very small (2-3 people including management); micro companies in many cases;
- They produce and market a small number of products which are vital for them. Loosing 1-2 products means often to close down the company;
- They are used to a very simple regulatory approach which indeed is not managed by internal experts. SMEs do not normally have regulatory experts or dedicated functions/offices. They do not understand toxicological, eco-toxicological requests for testing or the need to carry again efficacy trials;
- They are oriented to market other than safety. They believe their product are the best of all and nothing will clear them from the market;
- They think their products are absolutely efficacious even when applied with the new efficacy rules….some surprises around the corner happened;
- They are not used/not interested/not opened to deal with CA (Competent Authorities);
- When joining a Task Force or Consortium, they have difficulties in sharing information they consider CBI (Confidential Business Information) e.g. the formula, the production process, even though a Trustee has been appointed withing the group;
- They have reasonable economic difficulties in supporting the cost of a biocidal product authorization. This is the reason why they are happy to join a TF/Consortium but…with caution!;
- They consider the authorization as a direct cost and not as an investment on the product;
- They are already overwhelmed by numerous regulations/laws to be applied in their manufacturing sites (REACH, CLP, worker safety rules, waste water regulations, waste recovery and so on)
- They feel the competition with their competitors on “their skin” and a survival thing;
- They think they are the victims of the regulatory EU systems (legitimate sentiment) but….. they do not have the right approach and money to face/fight;
Conclusion
As said, SMEs are the core of the EU Business; certainly, they need to change their mentality when approaching such complex regulations as BPR. Firstly, they need to consider the money spent on authorization as an investment on the biocidal product/s and not as a mere cost. Company management (often the owners) plays a very important role on such an issue. More precisely they need to better address the investment on a product or products which are economically more relevant making a sort of selection in their product portfolio. This kind of selection must be done based of economic factors (value on the market) but also considering the defensibility of the products in terms of safety and efficacy (the safest and the more efficacious). It’s no longer the moment to have tens of weak product on the market; better few but strong and well set in terms of safety and efficacy.
Additionally, they need to appoint specific persons/experts who deal with the regulatory requirements (a different type of investment) or, alternatively, to use a consultant who is expert to talk with small organization rather than big ones and well introduced in the authority arena.
Lastly, but not least, they need to trust the Task Force or Consortium they are joining; this is the right and only way to stay alive in a complex and very regulated market.
