|Biocidal products contain active ingredients that are used to protect people and articles against pests or bacteria as and when needed.
Disinfectants are a type of biocidal product falling under A.I.S.E.’s product portfolio. They provide hygiene and disinfection when and where needed, and so play a part in protecting public health and supporting wellbeing.
In many parts of the world, hygiene is still a critical challenge, and lives are lost every day due to unsafe water, poor hygiene and sanitation. In Europe, hygiene standards are relatively high, but outbreaks of SARS, avian and swine flu, and MRSA have raised public awareness and concern about the spread of infectious diseases and the need for hygiene as a first line of defense.
Disinfectants placed on the market by A.I.S.E. members
are often niche products responding to specific hygienic needs. SMEs account for more than 70% of the companies in the market, and up to 100% in some European countries.
Biocidal Products Regulation
The Biocidal Products Regulation
(EU No 528/2012) that went into effect on 1 September 2013 regulates biocidal products in a harmonised way across the European Union to ensure that they are safe to put on the market. It repeals and replaces the 98/8/EC.
is assisting with its implementation in several ways by contributing to discussion and activities with the European Commission, the competent authorities and the European Chemicals Agency (ECHA
), and acting as a member of Biocides for Europe
(formerly know as EBPF), a CEFIC sector group.
supports the objective of a harmonised European market for biocidal products. We welcome new mechanisms introduced by the Regulation such as Union authorisation, harmonised risk assessment and the concept of biocidal product families.
Our view is that a harmonised internal market for biocidal products will help to improve product availability and provide incentives for innovation by reducing the administrative burden. It will also ensure that the same high standards for the protection of human health and the environment are applied across the European Union.
How we help
A key focus of our efforts is to minimise barriers to manufacturers, including the numerous SMEs
active in this field, for example by exploring options for joint authorisation procedures for those companies that have very similar biocidal products.
A.I.S.E. also organises workshops for members on biocides related topics.
A.I.S.E. & CEFIC EBPF survey report on BPR impact on biocidal products & innovation, released February 2016
About 2 years after the entry into force of the BPR, this report allows us to confirm that BPR costs are considered as definitely too high by companies: combined with the heavy technical and regulatory requirements, the high registration costs lead to withdrawal of many biocidal products currently on the market, and significantly hamper innovation in the domain of biocides. We anticipate that this trend will not improve as the active substances Review Program progresses.
On the other hand, despite the heavy burdens that the BPR imposes upon industry, the BPR presents a few opportunities for companies: the survey confirms the high interest from industry for the Biocidal Product Family and Union Authorisation approaches (as anticipated from our 2011 survey), allowing simplification and reduced administrative burden.
Download the full report here