Appendix 3
S.I. 2012/3032: memorandum from
the Department for Business, Innovation and Skills
Restriction of the Use of Certain Hazardous
Substances in Electrical and Electronic Equipment Regulations
2012 (S.I. 2012/3032)
1. By a letter dated 16 January 2013, the Committee
requested a memorandum on points 1 and 2 set out below in relation
to these Regulations.
(1) Explain, with reference if possible to
an example of requirements of other legislation that are "at
least as stringent" as those in regulation 18, but satisfaction
of which would not also in fact satisfy the requirements of regulation
18 (but for regulation 18(3))—
(a) what effect regulation 18(3) is intended
to achieve, and
(b) how the intended effect is achieved.
(2) Explain, with reference if possible to
an example of requirements of other legislation that are "at
least as stringent" as those in regulation 24, but satisfaction
of which would not also in fact satisfy the requirements of regulation
24 (but for regulation 24(3))—
(a) what effect regulation 24(3) is intended
to achieve, and
(b) how the intended effect is achieved.
2. The Department's response to question (1)
is as follows:
a. Regulation 18(3) transposes Article 7(h) of
Directive 2011/65/EU and is intended to permit a manufacturer
to comply with only one set of requirements for providing the
name and address of the manufacturer with a product, where they
manufacture a product that is subject to more than one EU regulatory
regime. This is intended to reduce the regulatory burden on manufacturers
where the specific details of the obligation to provide this information
differ, but the differing obligations could be seen as equally
effective.
b. An example of where regulation 18(3) is necessary
to achieve this result is Council Directive 93/42/EEC of 14 June
1993 concerning medical devices (Directive 93/42/EEC), which is
transposed by the Medical Devices Regulations 2002/618. Medical
devices can also be covered by the Restriction of the Use of Certain
Hazardous Substances in Electrical and Electronic Equipment Regulations
2012 (the RoHS Regulations). Under Directive 93/42/EEC, Annex
I, paragraph 13, a medical device must be accompanied by certain
information, including a label and instructions for use. The information
required on the label includes the name or trade name and address
of the manufacturer. However, there are also numerous additional
pieces of information that must be on the same label, including
special operating instructions, and warnings.
c. Annex I, paragraph 13.1 of Directive 93/42/EEC
states:
"As far as practicable and appropriate, the
information needed to use the device safely must be set out on
the device itself and/or on the packaging for each unit or, where
appropriate, on the sales packaging. If individual packaging of
each unit is not practicable, the information must be set out
in the leaflet supplied with one or more devices."
d. This sets a slightly different standard for
when the information must be on the device, but is arguably no
less stringent when read in the context of Directive 93/42/EEC.
The effect of regulation 18(3) in this situation is that where
a manufacturer affixes a label, including the name and address,
on packaging in accordance with Directive 93/42/EEC, they would
not also have to affix the name and address on the device itself
(even if it would technically be possible to do so).
3. The Department's response to question (2)
is as follows:
a. Regulation 24(3) transposes Article 9(d) and
is intended to achieve the same effect for the importer as regulation
18(3) achieves for a manufacturer. The example of Directive 93/42/EEC
can also be used in this context. Where a manufacturer does not
have a registered place of business in a Member State, they must
designate an authorised representative within the European Union.
Where a device is imported into the EU, the label or outer packaging
or the instructions for use must contain the name and the address
of the authorised representative.
b. In some cases, the authorised representative
under Directive 93/42/EEC may also be an importer for the purposes
of these Regulations. In this example, regulation 24(3) enables
an importer who is also an authorised representative subject
to the labelling requirements under Directive 93/42/EEC to meet
the labelling requirements in the RoHS Regulations, even if it
had not affixed its name and address to the device when it was
technically possible to do so.
Department for Business, Innovation and Skills
21 January 2013
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