Biocide
Biocidal Products Regulation
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.
For more information: https://www.echa.europa.eu
ERMA position on use of biocides by water-based resins producers key points
- ERMA is concerned by more stringent upcoming legislation on biocides which impacting biocide containing in water-based resins could develop creating an undesired situation.
- The contaminated water-based resins are normally unusable for our customers and end users. And the resins manufacturers’ facilities could be highly impacted by product contamination.
- Members of ERMA have for many years invested in R&D to optimize their products preservation, balancing the risk of microorganism growth in the product and using safe, approved biocides at the lowest possible concentration in a responsible manner. Labelling of products help consumers already have access to many information linked to CLP and also required by the specific Regulation such as BPR.
- ERMA members have experienced that the innovation is not only to have a new active substance, but part of a variety of integrated solutions such as formulations, plant hygiene, packaging, microbial control strategies with significant cost and time before final approval.
- ERMA Members and participants in 2019 ERMA Annual conference acknowledged that the use of preservatives in water-based resins and final products such as paints, printing inks and detergents is indispensable in the short/medium term, and that future availability of suitable preservatives is uncertain, it was therefore concluded that the issue has to be addressed in a pragmatic way under the BPR.
We continue to optimize our products preservation and provide customers and users the needed information to minimize the risks
and working with our partners in R&D projects for that
Biocidal Products Regulation (BPR)
BPR, concerns the placing on the market and use of biocidal products within the European Union.
The EU Biocides Regulation 528/2012 (EU BPR) covers a very diverse group of products, including disinfectants, pest control products and preservatives.
The biocidal products regulation (BPR) aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.
The BPR objective is to harmonise the market at Union level; simplify the approval of active substances and authorisation of biocidal products; and introduce timelines for Member State evaluations, opinion-forming and decision-making. It also promotes the reduction of animal testing by introducing mandatory data sharing obligations and encouraging the use of alternative testing methods.
All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. There are, however, certain exceptions to this principle. For example, Products containing new active substances that are still under assessment may be allowed on the market where a provisional authorisation is granted.
Biocidal Active Substances
The active substance/product-type combinations provided by ECHA are all those for which an application for approval has been submitted under Directive 98/8/EC or Regulation (EU) No 528/2012, including "existing" active substances included in the Review Programme and "new" active substances.
For checking and view quickly your biocide(s) status, select summary in following link:
https://echa.europa.eu/information-on-chemicals/biocidal-active-substances?
The status (Approved or Under review) of applications and approval of active substance/product-type combinations under the BPD or the BPR are included in summary table.
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Where an active substance has been approved, a link to the relevant legal act is provided.
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Where an active substance is not yet approved, it is indicated as "under review".
Review Programme for Existing active substance:
The Review Programme is the name commonly used for the work programme for the examination of existing biocidal active substances contained in biocidal products. The programme was set up by the European Commission under the Biocidal Products Directive (BPD) and continues under the Biocidal Products Regulation (BPR).
Existing active substances are those substances which were on the market on 14 May 2000 as an active substance of a biocidal product (for purposes other than scientific or product and process-orientated research and development). The existing active substances which were accepted to be examined in the Review Programme were those which were identified as such and for which a notification was accepted, as set out in Annex II to Commission Regulation (EC) No 1451/2007.
The detailed rules for the Review Programme have been adapted to the provisions of the BPR in the new Review Programme Regulation (EU) No 1062/2014, which repeals and replaces Commission Regulation (EC) No 1451/2007.
The transitional provisions laid down in Article 89 of Regulation (EU) No 528/2012 allow biocidal products containing an active substance included in the Review Programme (for a given product-type) to be made available on the market and used, subject to national rules, until three years after the date of their approval (shorter timeframes apply in case of non-approval).
In Annex II part 1 of the Review Programme Regulation, the active substances which are under evaluation are listed.
In addition, the Review Programme Regulation adapts the processes for the evaluation of a dossier to align them to those described in the BPR for new active substances or in Regulation (EU) No 88/2014 for the amendment of Annex I.
Furthermore, the Review Programme Regulation provides a defined role for ECHA and sets out procedures on how to join or replace a participant in the Review Programme by mutual agreement, how to withdraw as a participant, how to take over the role of participant in certain situations and introduces the possibility to add substance/PT combinations to the Review Programme, under certain conditions.
The Review Programme is foreseen to be completed by 2024.
Link for more information:
https://echa.europa.eu/regulations/biocidal-products-regulation/understanding-bpr
For more information please see ERMA members area