POSITION PAPER
BDI position paper on notification and information obligations
under REACH concerning candidate list substances in
articles
21/09/2016
General
Under the REACH Regulation (EC) No. 1907/2006, both a duty of notification vis-à-vis
the European Chemicals Agency ECHA (Article 7 (2)) and a duty of information vis-à-vis
trade customers and consumers (Article 33) are applicable for producers and importers
of articles.
Notification and information duties
According to Article 7 (2), producers or importers of articles must notify ECHA if their articles contain candidate list substances. This becomes necessary if a candidate list substance is present in an article produced or imported at a concentration above 0.1% (w/w)
and if the total amount of the substance present in all articles which contain more than
0.1% (w/w) of the substance exceeds 1 tonne per year for the producer/importer (Article
7 (2) and (4)). The duty of notification no longer applies if the substance has already
been registered for the corresponding use (Article 7(6)) or if exposure to humans or the
environment can be excluded (Article 7(3)).
The duty of information vis-à-vis trade customers for an article arises in accordance with
Article 33 if the article contains more than 0.1% (w/w) of a candidate list substance. In
this regard, the supplier must provide the customer with the available information which
is necessary to allow safe use of the article. This must include at least the name of the
candidate list substance. This information has also to be provided to consumers upon request. Consumers have to be provided with this information within 45 days of their request.
ECJ ruling on the reference value for determination of the 0.1% (w/w) threshold
In past years, different Member States held different views as to whether, in the case of
complex articles, the reference value to be taken into account for the 0.1% (w/w) threshold is the weight of the total complex article or that of the individual constituent article
(“component” in the ECJ ruling).
Dr. Mirjam Merz.| Umwelt, Technik und Nachhaltigkeit | T: +49 30 2028-1644 | [email protected]
BDI position paper on notification and information obligations under REACH concerning candidate list substances in articles
21/09/2016
With the ruling C-106/14 of the European Court of Justice (ECJ) of 10 September 2015, it
has been clarified from a legal standpoint that a constituent article incorporated in a complex article continues to be an article and hence the concentration of the candidate list substance must be determined with reference to each constituent article (and not with reference to the entire complex article).
In addition, with regard to the duty of notification in accordance with Article 7(2) REACH, the
ECJ underlined that producers of complex articles have to make notifications to ECHA on
candidate list substances in articles only for those constituent articles that they have produced themselves. According to the ruling, this should prevent “duplicate” notifications.
However, importers are obliged to notify ECHA with respect to all constituent articles.
Revision of the ECHA Guidance on requirements for substances in articles
The ECHA Guidance on requirements for substances in articles is currently being revised to
reflect the ECJ’s ruling. ECHA’s draft is presently under consultation in the competent Partner Expert Group (PEG). As it stands, the draft contains various examples of the different
implementation problems regarding the notification and information duties which serve as
the basis for recommendations to industry on implementation of these duties.
Assessment
Implications for industry
The notification and information duties of producers and importers of articles have been
clarified from a legal standpoint with the ECJ ruling. Nevertheless, even following clarification by the ECJ, companies face considerable challenges since practical implementation of
the notification and information duties continues to be difficult – especially for highly complex articles. Against this background, the update of the ECHA guidance in particular is of
central importance for industry. In BDI’s view, the guidance should explain implementation
of the notification and information duties using clear examples.
Complex industrial articles often consist of a large number of constituent articles. For instance, a vehicle comprises several hundred thousand constituent articles; an aircraft can
consist of up to 2,000,000 constituent articles. A complete subdivision of complex articles
into all constituent articles together with identification and provision of information on the
content of the candidate list substance in relation to all individual constituent articles involves an immense effort in terms of time and bureaucracy. This effort is out of all proportion to the expected benefit for the professional customer or consumer. In addition, it can be
anticipated that producers and importers will not recieve the necessary information in a
number of cases since non-EU suppliers are not willing to make this information available
for economic reasons due to the great effort involved. As a result of this, it may even be totally unattractive for non-EU suppliers to supply European customers so that constituent articles might not be available in the desired volume or at the required quality.
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BDI position paper on notification and information obligations under REACH concerning candidate list substances in articles
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Alongside the problems of establishing and providing information, it should also be borne in
mind that the volume of information provided is so large for very complex articles that customers and consumers might no longer have an overview of the concrete relevant information content and cannot use it sensibly.
Against this background, industry believes it urgently necessary to identify appropriate solutions that would meet the objectives pursued with the notification and information duties on
the one hand and limit the burdens for companies to a proportionate degree on the other
hand.
This has not been achieved with the draft ECHA guidance currently on the table. In particular, it is disappointing that the examples chosen in the guidance are of only limited complexity (e.g. printed T-shirt, sofa, air mattress, garden chair, etc.) and accordingly do not fully address and respond to challenges and issues which face especially producers and importers
of complex articles. In the cases where more complex examples are cited (e.g. bicycle and
printed circuit board), the subdivision is not carried out completely into the individual constituent articles and the duty of information is explained only in relation to a few constituent articles. The justification put forward by ECHA (that the examples cannot be worked through in
their full complexity due to the large number of constituent articles comprised in the articles
chosen as examples) highlights the implementation problems raised by industry and illustrates that the implementation of the information duty called for in the ECHA guidance especially for more complex articles is not possible with a proportionate effort.
German industry’s requests
For the stated reasons, German industry calls for the establishment of appropriate and
workable solutions for the implementation of notification and information duties in accordance with Article 7 (2) and Article 33.
1)
Definition of “cut-off” criteria / limitation of the subdivision depth for complex
articles
In industry’s view, the requirement to identify and provide information on the concentration
of candidate list substances in relation to each individual constituent article even in the case
of complex articles is not compatible with the principle of proportionality due to the large
number of constituent articles in complex articles. Thus, the subdivision depth must be limited to a suitable level in the case of very complex articles.
Under European law, all encroachment by the public administration into the rights of the individual is subject to the principle of proportionality. According to Article 5 TEU, the principle of proportionality also applies expressly for implementation of the EU’s legislative acts.
Article 5 (4) TEU stipulates: “Under the principle of proportionality, the content and form of
Union action shall not exceed what is necessary to achieve the objectives of the Treaties”.
Whether a measure is proportionate is determined by whether the measure is suitable and
necessary for achieving the desired objectives. Furthermore, it should be examined
whether the measure is also proportionate in the narrower sense. This means that a
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BDI position paper on notification and information obligations under REACH concerning candidate list substances in articles
21/09/2016
measure must be withheld if the disadvantages to be expected from the measure for those
affected is disproportionate to the intended success.
The objective pursued by the information duty in Article 33 of the REACH regulation is to
ensure safe use of articles for humans and the environment.
For complex articles, it must be taken into account that many of the individual constituent
articles are incorporated in the internal workings of the overall product and that therefore,
within the normal or reasonably foreseeable use, exposure is not to be expected. Safe use
of the overall product is still ensured in these cases if certain complex assemblies are not
further subdivided and the information is not provided in relation to all individual constituent
articles. Determination and provision of information on the concentration of candidate list
substances in articles is therefore often not necessary in relation to every individual constituent article. In the case of fully incorporated constituent articles, the duty of information
with a limited subdivision depth (communication at the level of complex assemblies) may be
suitable for achieving safe use. This is supported by the fact that assembly designations
are as a rule more tangible and therefore easier for users and consumers to understand
than designations of individual constituent articles which are often very specialised or cryptic (e.g. a type designation). Consequently, implementation of the duty of information in relation to every individual constituent article as called for in the guidance is an excessively
heavy burden for companies in relation to the purpose of the provision and hence is also not
proportionate in the narrower sense. There is therefore an urgent need to limit the subdivision to a reasonable level for complex articles.
In industry’s assessment, the establishment of generally applicable “cut-off” criteria for limiting the subdivision depth is not possible given the strong heterogeneity of articles. On the
side of the authorities, an approach has repeatedly been encouraged in the past whereby
“cut-off” criteria should be set on a case-by-case basis. However, in BDI’s view, this does
not offer adequate legal certainty and is therefore not the right approach.
BDI therefore proposes the definition of examples of assemblies for which a further subdivision is not reasonable and is not possible with appropriate effort. In this context, assemblies
can be established in particular where the further subdivision effort is very high without that
the detailed consideration of individual constituent would result in enhanced safety for customers and consumers. This is the case, for instance, where incorporated assemblies are
concerned for which exposure is not to be expected with the normal or reasonably foreseeable use or for which exposure can be excluded with appropriate instructions from the producer.
Such examples for assemblies where a further subdivision is not sensible should either be
included in the ECHA guidance or made available on ECHA’s homepage. The latter would
have the advantage that such a list would not be definitive and could be open for additions
to reflect experiences with implementation of notification and information duties.
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BDI position paper on notification and information obligations under REACH concerning candidate list substances in articles
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The table below summarises initial examples for defined assemblies where industry believes a further subdivision is not the right approach nor proportionate. The following criteria
have been built on the named aspects in order to define the assemblies:
A. Enclosed assemblies: safe use is guaranteed throughout the service life within the
normal or reasonably foreseeable use since a release of candidate list substances in
enclosed components can be excluded.
B. Assemblies with a high density of very small components: safe use is guaranteed
throughout the service life within the normal or reasonably foreseeable use since a
release of candidate list substances is highly improbable. A further breakdown is
therefore disproportionate.
C. Assemblies with a high density of individual component articles but a very limited
number of component substances: an individual consideration is not possible due to
the similarity of the component articles.
Assembly (reference for duty of
information in accordance with
article 33)
printed circuit boards or conductor film
measurement, control and regulation technology sensors
measurement, control and regulation technology actuators
button cells/semi-conductor batteries
adhesive tapes and labels
Component constituent articles (selection) for which no further stand-alone
information is gathered (coverage via
the assembly sufficient)
> 300 constituent articles depending on
size, for example baseplate (Glass fibre
fabrics, copper foil, lacquer layer, solderable surface layer), isolation layer, interconnects, solders, attachments e.g. capacitors, transistors, inductors, diodes, microchips, microprocessors , switch, additional
electronic modules (housing, sensor modules (caps, o-ring, mounting, carrier film,
isolation, coils), connector-modules (carrier film, o-ring, connector, isolation)), fans
etc.
electronic components, printed circuit
board or conductor film, metal or plastic
housing, cables (copper wire, insulators),
plugs (plastic housing, contact pins), orings, stranded wires (copper wire, insulator), various insulation elements
electric motor, movement controls, angle
sensor, length sensor, cabling, electronic
components (semi-conductor, diode), etc.
casing (cell bowl, plastic sheath), positive
pole, negative pole, separator, electrodes,
insulating discs
Protective film, adhesive layer, primer,
support material, e.g. plastic film or mesh
(textile), imprint, cover film
Criterion
B
A, B
A, B
A
C
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BDI position paper on notification and information obligations under REACH concerning candidate list substances in articles
21/09/2016
Assembly (reference for duty of
information in accordance with
article 33)
LED lamps
ammunition and projectiles
pyrotechnic objects such as projectile cartridges for technical purposes, force elements, fireworks,
signal rockets
antennas
hybrid seals
bearings
sheathed cable (including plug)
composite component
2.)
Component constituent articles (selection) for which no further stand-alone
information is gathered (coverage via
the assembly sufficient)
around 115 constituent articles (including
wire, resistor, capacitor, diode, shrink
tube, transistor, silicon, printed circuit
board, lens, adhesive tape, heat sink,
housing, base pins, fuse, coil, diode, LED)
electric and mechanical primers and igniters; delay elements; tracers; (shaped) explosive charges (main booster, transfer
charge); pyrotechnic active masses
(shapes: flares, pellets, pressed bodies;
effects: infrared, lightning, flash / bang,
smoke, irritant); bullets / projectiles;
(shaped) propellants
formed propellants (e.g. compact propellant pellet),
ignition caps, fuzeheads, delay elements
Criterion
plastic sheath, copper cable, other metals
(conductive materials)
metal ring, elastomer
inner ring, retainer, sealing disc, rolling element, outer ring, etc.
copper wires, insulators, plastic housing,
contact pins
carbon fibres, glass fibre, mesh (nylon, aramid or dyneema), metal mesh and metal
strips
B
A, B
A
A
A
A
B
C
Limitation of information on the content necessary for safe use
Regarding the scope of the information to be provided within the supply chain, it is specified
in Article 33 that the supplier of the article must provide the customer with sufficient information, available to the supplier, to allow safe use of the article, including at least the name
of the substance.
The requirements for the scope of information have been considerably extended in the current draft of the ECHA guidance. In section 3.4.1 of the guidance, it is explicitly indicated
that “providing only the name of the substance is unlikely to be sufficient to allow safe use of
the article in many cases" (page 32, second paragraph). Rather, ECHA places greater focus
on the aspect that further information needs to be identified and if necessary passed on to
the customer for being in line with Article 33 when a candidate list substance is present in
an article. In this regard, ECHA recommends that the entire lifecycle including waste management and recycling should be taken into account.
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BDI position paper on notification and information obligations under REACH concerning candidate list substances in articles
21/09/2016
In the ECJ ruling it is pointed out that an object is no longer an article for the purposes of
the REACH regulation if it becomes waste within the meaning of Union law (cf. point 52). Inasmuch, there is no duty of information as stipulated in Article 33 in relation to waste. Accordingly, in industry’s view, the extension of the duty of information proposed in the draft
guidance also to the waste management/recycling lifecycle phase is not covered by the
REACH regulation. In addition, the provision of Article 33 information through to waste management is not feasible in practice in particular for consumer products in the private sector
and also not provided for in law since a consumer is not an “industrial or professional user”
or a “downstream user” of articles ((REACH Article 3 (13 and 35)). In industry’s view, for this
reason, too, the duty to prepare information especially on waste management called for by
ECHA in the guidance is not the right approach.
Both points make it clear that the widened requirements for information content go well beyond the obligations enshrined in Article 33. In particular, the comprehensive risk analyses
for all lifecycle phases of an article called for in the ECHA guidance widens the scope of information procurement considerably and should not be a task for the supplier of an article
on the basis of the regulatory content of Article 33.
BDI therefore calls for the information to be provided in the supply chain in application of the
REACH regulation to remain limited to those information on the safe use of the article available to the supplier and relevant for safe use of the product and the name of the candidate
list substance contained in the constituent article.
3.)
No localisation of constituent articles comprising candidate list substances
It is explicitly required at various points in the ECHA guidance that, alongside indication of
the candidate list substance, the name of the constituent article in which the substance is
comprised must always be given (e.g. page 73, second paragraph: “has to communicate...
the presence of candidate list substance 2 in the cushions and of candidate list substance 1
in the textile fabrics”). In addition, ECHA makes it clear in various examples that the constituent article must be clearly identifiable. According to ECHA, if the name of the constituent
article on its own is not conclusive, further information for clear identification of the constituent article must also be given (e.g. page 87, third paragraph: “... has to communicate ... the
presence of the Candidate List substance 1 and 2 for each type of article incorporated into
the imported mulita-socket power strips, with sufficient specificity to allow safe use of the
multi-socket power strips, as well as any other information to allow its safe use including
disposal”).
This call for an exact localisation of the constituent article comprising the candidate list substance goes clearly beyond the obligations enshrined in Article 33 and cannot be justified by
the ECJ’s ruling either. The ECJ supports its ruling with the following justification: “Its scope
[the duty of information], however, is limited by Article 33 thereof, which states that ‘sufficient information, available to the supplier, to allow for safe use of the article in question’
must include, as a minimum, the name of that substance. That requirement, which is mini-
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BDI position paper on notification and information obligations under REACH concerning candidate list substances in articles
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mal in nature, cannot be regarded as being an excessive burden.” (point 81 of the ECJ ruling). This would be contradicted by the corresponding extension of the duty of information
as provided for in the ECHA guidance.
For companies, the obligation to indicate precisely where every constituent article in question is located would involve a disproportionate communication effort, since a clear identification of individual constituent articles in highly complex products would be possible only,
for example, via publication of construction plans. This is out of all proportion to the purpose
of information provision, since safe use can be ensured also without precise localisation
(e.g. through identification of the assembly in which the constituent article is comprised). In
addition, precise localisation of individual constituent articles attracts criticism from the angle of competition law or export law, because this would involve publication of confidential
product information which must under no circumstances be accessible to competitors or is
even subject to confidentiality under export legislation.
By contrast, if the information provision in accordance with Article 33 would take place as
proposed by BDI at the level of assemblies, the problem of localisation would disappear as
a rule, since assembly designations are easier for industrial or professionally users and consumers to understand and the assemblies can therefore be better identified (cf. request no.
2 on pages 6/7).
Furthermore, the REACH regulation sees the information provision as a bilateral obligation
between a supplier and its concrete customer and not as an obligation to communicate
along the entire possible supply chain. Only in this way it will be ensured that targeted and
comprehensible information on safe use is provided to the relevant subsequent party. Specifically in cases of long-standing supply situations, the name of the substance will be sufficient because the producer ought already to have passed on sufficient knowledge about
safe use of the article and/or the candidate list substance it contains to the distributor or
customer, e.g. on risk assessments and a health and safety management plan.
4.)
No requirement for notification declarations
According to the ECJ ruling of 10 September 2015, a producer of assembled articles only
has to notify only in relation to those constituent articles hehas produced himself. This is
supposed to prevent duplicate notifications to ECHA.
A “notification declaration” is mentioned and it is advocated at various points in the draft
ECHA guidance that a producer should ask suppliers of constituent articles whether a notification has already been made. In industry’s view, this recommendation must be deleted
from the guidance, since it goes far beyond the requirements enshrined in the REACH regulation. Article 7 (2) provides merely for ECHA to be the recipient of a notification and hence
also of an associated declaration. This serves exclusively as the basis for a decision by
ECHA on an additional registration obligation for substances in articles (Article 7 (5)). Requiring a customer to acquire a notification declaration would be a reversal of the burden of
proof. According to Article 7 (2) of the REACH regulation, each producer is required to
make a notification for the articles it produces if certain conditions are met (candidate list
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BDI position paper on notification and information obligations under REACH concerning candidate list substances in articles
21/09/2016
substance content more than 0.1% (w/w), total quantity of candidate list substance more
than 1 tonne/year in all articles of an operator). Within European supply chains, a customer
must be able to rely on the supplier being REACH-compliant and having met the duty of notification.
The mention of a “notification declaration” in the ECHA guidance can lead to uncertainty
among companies which do not have an in-depth knowledge of the REACH regulation and
result in undesirable domino effects and an unjustified communication effort within the supply chain through the request of “notification declarations”.
Impressum
Bundesverband der Deutschen Industrie e.V. (BDI)
Breite Straße 29, 10178 Berlin
www.bdi.eu
T: +49 30 2028-0
Redaktion
Dr. Mirjam Merz
T: +49 30 2028-1644
[email protected]
D 0803
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