Questions and Answers

REACH

Authorisation

Applications for Authorisation - a) Scope and procedure

[1027] Article 2(5), subparagraphs (a) and (b), and Article 56 subparagraphs (4)((a), (b), and (c)) and (5)((a) and (b)) of REACH exempt from the authorisation requirement a number of uses in products (medicinal products, food or feedingstuffs, plant protection products, biocidal products, motor fuels, cosmetic products and food contact materials, respectively) within the scope of, or covered by, the sector-specific Union legislation specified in those provisions. 1. Do these exemptions cover the incorporation of the Annex XIV substance into the product during the manufacturing process? 2. Do these exemptions also cover the life-cycle steps (such as formulation) preceding the incorporation of the substance into the product in question?
REACH
Authorisation
Version: 1.0
Latest update: 04/06/2015

  1. Yes, these exemptions cover the incorporation of a substance into the product during the manufacturing process.
  2. Yes, the uses of a substance upstream preceding an exempted end-use are also exempted but only in the volumes ending up in the exempted end-use.  It should be noted that, with regard to uses in cosmetic products and in food contact materials, the exemption only applies when the intrinsic properties specified in Annex XIV for the substance in question concern hazards to human health.
 
[1028] Article 56 (4)(d) of REACH contains an exemption from the authorisation requirement for the use as fuels in closed systems. Does this exemption also cover the life-cycle steps (such as formulation) preceding this end-use?
REACH
Authorisation
Version: 1.0
Latest update: 04/06/2015

Yes, the uses of a substance upstream, preceding "use as fuels in closed systems", are also exempted under the condition that the control of the risks – i.e., use in closed systems – is also pursued in the upstream life-cycle steps preceding the end-use as a fuel.

[1029] Does an application for authorisation for the use of a substance in a medical device regulated by the sector-specific legislation referred to in Article 60(2) 2nd subparagraph of REACH have to be submitted for a substance for which Annex XIV specifies human health hazards only? Does this exemption cover the incorporation of the Annex XIV substance into the product during the manufacturing process? If so, are the life-cycle steps preceding the incorporation of the substance in the medical device subject to authorisation?
REACH
Authorisation
Version: 1.0
Latest update: 04/06/2015

Pursuant to Articles 60(2) and 62(6) of REACH, an application for authorisation is not required for a substance used in a medical device regulated under Directives 90/385/EEC, 93/42/EEC or 98/79/EC if that substance has been identified in Annex XIV for human health concerns only.   Nor is an application required in such cases for the incorporation of the substance into the medical device during the manufacturing process or for the uses and corresponding volumes of that substance upstream preceding the end-use.

[1030] Article 56 (3) of REACH exempts from the authorisation requirement the use of a substance in scientific research and development (SRD). Does this exemption also cover the life-cycle steps (such as formulation) preceding the end-use in SRD?
REACH
Authorisation
Version: 1.2
Latest update: 18/02/2016

Yes, the uses of a substance upstream preceding an exempted end-use in SRD are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to what is set out below.
 
Article 3(23) defines SRD as any scientific experimentation, analysis or chemical research to be carried out "under controlled conditions" and "in a volume less than one tonne per year". Therefore, the exemption in Article 56 (3) covers an activity which is delimited by a certain level of control of risks– i.e., use under controlled conditions and in a volume less than 1 tonne per year. It also applies to the upstream life-cycle stages of the substance preceding its end-use in SRD, for the volumes ending up in that end-use and which, during the upstream life-cycle, are handled and/or used under controlled conditions, even if the volume handled and/or used during the upstream life-cycle stages exceeds 1 tonne per year.

In case of any contradictions between the position expressed in this Q&A and the positions expressed previously by ECHA in the RCOM of 20 December 2011, the position expressed in this Q&A should be considered as the current understanding of the law. It takes precedence over any other views communicated previously by ECHA on this issue.
 
[1031] Is the manufacture of a substance, whether for export or placing on the EU market, subject to the authorisation requirement?
REACH
Authorisation
Version: 1.0
Latest update: 04/06/2015

The manufacture of a substance is not subject to the authorisation requirement. After a substance has been manufactured it may have to be handled before it is exported or placed on the EU market. Operations which are necessary for the handling of a substance on its own in the manufacturing for export or placing on the EU market are considered to be part of the manufacturing stage (e.g. filling into appropriate containers, storage, addition of stabiliser, dilution to a safer concentration -if necessary for transport safety-), but not other uses such as the formulation of a mixture or incorporation of the substance into articles. The formulation of a mixture or incorporation of the substance into articles are considered "uses" within the meaning of Title VII of REACH and are subject to the authorisation requirement whether or not the mixture or articles will be exported or placed on the EU market.