EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE GENERAL
Safety of the food chain
Pesticides and Biocides
CA-Sept15-Doc.5.1.b-Final
61st meeting of Representatives of Members States Competent
Authorities for the implementation of Regulation (EU) No
528/2012 concerning the making available on the market and use
of biocidal products
Management of in situ generated active substances in the context of the BPR
The case of free radicals1
1. Introduction
The case of free radicals and photocatalysts was discussed at previous CA meetings and
different possible interpretations of the legislative framework suggested with a view to clarify
the regulatory status of free radicals2.
Comments were received from two Member States and one stakeholder indicating that they
could not agree with the viewpoint that free radicals are not covered by the REACH substance
definition. They made the following comments.
The REACH definition ‘substance: means a chemical element and its compounds in the
natural state or obtained by any manufacturing process, including any additive necessary to
preserve its stability and any impurity deriving from the process used, but excluding any
solvent which may be separated without affecting the stability of the substance or changing its
composition’, in our opinion does not exclude radicals from its scope.
Radicals may be regarded as a reactive chemical composition of one or more chemical
elements (e.g. O and H). The fact that these radicals are under normal environmental
circumstances not stable, and may only be generated in large amounts intentionally under
specific conditions, does not preclude them from falling within the REACH substance
definition.
1
This note addresses the case of free radicals that are intentionally generated for a biocidal purpose.
See CA-March15-Doc.5.1-rev1 - Substances generated in situ and CA-May15-Doc.5.1.c - Free radical-ions
and photocatalysts
2
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11
E-mail: SANTE-BIOCIDES@ec.europa.eu
In addition, the fact that free radicals will not be registered as substances within the scope of
the REACH registration obligation of manufacturers and importers, is merely a logical
consequence of their instability and the fact that they will normally neither be manufactured
nor placed on the market intentionally. As a consequence, radicals will fall under one of the
various exemptions from REACH registration through its Annex V (e.g. for products that are
formed through chemical reaction and themselves are not placed on the market).
One Member State however agreed that free radicals do not fulfil the definition of a substance
according to REACH.
Another stakeholder pointed out that Hydroxyl radicals survive only for milliseconds and
cannot be measured even with advanced chemical analysis. Furthermore, that stakeholder
explained that hydroxyl radicals are typically generated in several types of Advanced
Oxidation Processes (abbreviated as AOP), the radical step allows to break up aromatic
rings, etc. of recalcitrant substances. AOP is for example typically used for clean-up of waste
waters. The majority of these processes has nothing to do with disinfection at all, at least not
aimed. So the excess of the use of hydroxyl radicals are out of the scope of the BPR, and,
again, were disinfection occurs it is a non-aimed side effect.
Finally, another stakeholder expressed concerns on the socio-economic consequences of
bringing free radicals within the scope of the BPR.
2. Way forward
A free radical is chemically defined as an atom or group of atoms that contains at least one
unpaired electron. These unpaired electrons make free radicals highly chemically reactive.
As an example, hydroxyl free radicals (˙OH) can be generated from water, ambient air and
UV-light using photocatalysts (e.g. titanium dioxide), but also from water and ambient air by
electric discharge.
As stated above, free radicals meet the definition of a substance as defined under REACH and
should therefore be regarded as active substance under the BPR, when they are used for a
biocidal purpose.
Furthermore, for the sake of simplification, and for the purpose of the substance approval, the
active substance shall be defined by mentioning only the free radical without reference to the
precursor(s) or method of generation.
For the purpose of helping companies to prepare their applications for both substance
approval and product authorisation, guidance shall be developed to specify the data required
in such applications. In view of the deadline of 1 September 2016, by which applications for
substance approval have to be submitted (see below), guidance on data requirements for
active substances shall be developed and agreed as a matter of priority.
As free radicals were not considered as falling within the scope of the BPD, but are now
under the scope of the BPR, applications for the approval of free radicals, such as hydroxyl
radicals, as active substance and their authorisation as biocidal products3 will have to be made
on the basis of and in accordance with Article 93 of the BPR.
3
This would also include the authorisation of the precursors as biocidal products, when these precursors are
supplied with the intention to generate free radicals for a biocidal use.
2
Thus, a given free radical can be used for a biocidal use:
a) until 1 September 2017, if no application for the approval or inclusion into Annex I to
BPR as an active substance of that free radical is submitted by 1 September 2016,
b) until the deadlines provided in Article 89(2), (3) and (4) of the BPR, if an application
is submitted by 1 September 2016.
Finally, it shall be noted that:
a) By analogy with bacterial cultures that are intended to reduce organic solids4,
advanced oxidation processes, in which hydroxyl radicals are generated to break down
recalcitrant (micro)pollutants in water, and which may also have a side effect on
unwanted organisms present in water, are not biocidal products provided they are not
intended for the purpose of destroying these unwanted organisms and no claim is
made that they can be used for such purpose.
b) Ultraviolet (UV) disinfection devices, commonly used in drinking water disinfection,
and intended to degrade through the effect of UV light5 the DNA and RNA of viruses,
bacteria and protozoans so that the ability of these unwanted organisms to multiply is
impaired, are not biocidal products provided they only act by physical means.
3. Conclusions
The Commission services invite Member States to discuss and endorse this note during the
CA meeting.
4
5
Commission Implementing Decision (EU) 2015/646 of 23 April 2015 pursuant to Article 3(3) of Regulation
(EU) No 528/2012 of the European Parliament and of the Council on bacterial cultures intended to reduce
organic solids and to be placed on the market for that purpose (Text with EEA relevance) OJ L 106,
24.4.2015, p. 79–79
In such process the formation of free radicals is an unwanted effect, which is prevented through different
technical means.
3