Pharmaceutical Manufacturer Obligations Under The EU Biocidal Products Regulation

There is a global trend within the chemical industry with regulators tightening legislation and implementing stricter controls to ensure human and environmental safety protection. This is leading to a reduction in the number of biocide active ingredients, and in turn, a more robust approval processes for disinfectants and other biocidal products. A notable example of these changes is the European Biocidal Products Regulation (BPR) No. 528/2012 which entered into force in September 2013. The BPR is applicable to all European Union countries as well as Iceland, Liechtenstein, Norway and Switzerland.

What is the objective of the BPR?

The regulation is designed to control the use of, and placing on the market(selling) of biocidal products. It involves the utilization of a registered active, an assessment of a biocidal product’s efficacy, toxicity and the risk during use.

Additionally, it requires robust data to prove the effectiveness and safety of the biocidal product, a list of approved active substance and suppliers, and a harmonized system for authorization of biocides across the European market.

Improving the control on biocidal actives and the suppliers – Article 95

To ensure additional control of biocidal actives on the European Market, existing actives are undergoing a re-evaluation via registration under the BPR.  In addition, Article 95 of the BPR came into force in September 2015, and states that a supplier of any ‘Active’ intended for use within a biocidal product must be registered and present on the Article 95 list.  Disinfectant products utilizing biocidal actives from a non-compliant Article 95 supplier are illegal.

The applicability of the BPR to on-site manufacture and use of biocidal products

As the scope of the BPR includes the “use of biocidal product”, any alcohol-based or biocide-based mixture prepared on site and used on site for disinfecting purposes is within the scope of the BPR and requires product registration. Furthermore, the alcohol and biocidal active in any produced mixture, as per the above scenario, needs to be sourced in compliance with Article 95.

What are Pharmaceutical End users’ obligations under the BPR?

• Pharmaceutical industry customers need to ensure that biocidal products supplied for use in their manufacturing sites are registered in the relevant country of operation. It is illegal to sell or use an unapproved biocidal product.
• The suppliers of these disinfectant products need to have made an investment to register their products under the BPR.
• Any biocidal active purchased for on-site use needs to be from an approved source as per Article 95 of the BPR.
• Any product manufactured on a Pharma site and used for biocidal purposes is subject to BPR registration.

What is Ecolab Life Sciences’ BPR compliance status?

• Ecolab can confirm that all our biocidal product actives are sourced in compliance with Article 95 of the BPR.
• We have made a substantial investment to ensure that our products are compliant to the requirements of the BPR and other relevant EU legislation – including CLP and REACH regulations, and the proposed EudraLex vol 4, Annex 1.
• Our products are safe and efficacious.
• We have the regulatory expertise and resources to ensure full and sustained regulatory compliance in Europe, as well as Global markets.
• We can guarantee long-term and continued product supply.