We recognise that compliance with REACH regulations is an increasingly critical issue for our customers and the industry, and has been the subject of much comment recently regarding supplier and converter obligations.
REACHready, a UK designated Authority and National Helpdesk, have written the following article to give clarity on this matter.
Sheet rubber definition:
Synthetic or natural rubber in the form of a sheet that may be used directly in applications such as flooring or further processed into new articles having numerous and various applications, such as gaskets. The most important definition in regards to REACH is that sheet rubber is considered an article. REACH defines an article as a product that has a special shape, surface or design that is more important to its function than its chemical composition.
The aspects of REACH that are most likely to affect gasket cutters are those obligations of REACH for importers, producers and suppliers of articles. Registration may also be applicable for manufacturers and importers of polymers (the monomers may need to be registered since polymers themselves are currently exempt from registration), although registration does not normally apply to articles and so will not be the focus of this piece. It should be stated that an actor in the supply chain may fall into multiple categories and hence take on all of the applicable obligations. Registration may affect importers and producers of articles but only in special cases whereby a substance that is part of the article is intended to be released, forming a secondary function of the article. An example of which is scented bin liners, this is unlikely to apply to gasket cutters.
Substances of Very High Concern (SVHCs) that have been added to the Candidate List have obligation implications for importers/producers/suppliers of articles. The obligation to submit a notification to the European Chemicals Agency(ECHA) is triggered for importers and producers of articles when all three criteria are met (according to Article 7(2) of REACH):
1) the SVHC is on the Candidate List;
2) the SVHC is present in a concentration > 0.1% by weight; and
3) the SVHC is present in those articles in quantities totalling over one tonne per importer or producer per year.
If there is already a registration for the substance in question and the registration covers the use for which the article is used, the SVHC is considered exempt from the notification obligation. The advised way to submit a notification is through the streamlined process of submitting a webform to ECHA on their website.
The second obligation that the presence of substances on the Candidate List in articles triggers involves suppliers of articles. The term suppliers also covers producers and importers of articles. This obligation relates to the communication of information with the supply chain (Article 33 of REACH) they are:
1) suppliers of articles containing a SVHC > 0.1% by weight are required to provide sufficient information to the recipient of the article to allow safe use of the article; and
2) on request by a consumer, a supplier of an article containing a SVHC > 0.1% by weight shall provide the consumer with sufficient information to allow safe use of the article within 45 days of the request.
In both the notification and communication cases, the minimum information requirement is the name of the substance although satisfying the criteria to permit safe use of the article must be considered in reference to whether the substance name alone enables safe use to be undertaken.
The Candidate List can be found on ECHAs website, REACHReady also have a versatile and searchable database with common uses (also searchable by this criteria) available to Gold Subscribers. Demonstrating the necessity to remain up to date with REACH, the CL is updated (normally twice yearly) with the most recent update on 17 December 2015 including the addition of five substances to the list. There is a transitional period of 6 months for the obligations described above to be implemented by the relevant parties from the date the substance is added to the CL. A quick search on our database for the use term rubber yielded a total of 31 results out of the 168 entries the CL has at the time of writing. Some examples are: 2,2-dichloro-4,4-methylenedianiline (MOCA) (EC no 202-918-9); 4-(1,1,3,3-tetramethylbutyl)phenol, (4-tert-Octylphenol) (EC no 205-426-2); and 4,4-diaminodiphenylmethane (MDA) (EC no 202-974-4). It is legal to use substances on the CL provided the obligations under REACH are met in order to achieve compliance. Another important implication of a substance being on the CL is that it is a Candidate for being added to the Authorisation List (Annex XIV), upon which the use of the substance is only permitted if there is an exemption or a valid authorisation is held.
It is necessary to be aware of the Authorisation List (or Annex XIV). Substances on this list cannot be used unless (as previously stated) a valid authorisation is held or an exemption applies. Note the term used, there is nothing in REACH that bans the import of articles containing substances in Annex XIV. If an article is purchased from within the EU and contains a substance on the authorisation list, the actor in the supply chain that uses the substance will be liable for compliance with Authorisation. It is likely that the most applicable information for members of the GCA is that if a substance is integral to the manufacture/performance of an article and it is present on the Candidate List, there is a chance it will be placed on the Authorisation List and this may jeopardise future availability of said article (if the article is produced in the EEA). Import of substances integral to articles that appear in Annex XIV is not banned under REACH; having said that, restrictions may apply in addition to notification and communication duties. NB: if a substance appears on the Authorisation List, it is also on the Candidate List, it does not get removed from the CL upon addition to Annex XIV.
Another aspect of REACH affecting articles is restrictions, these define criteria in which substances or classes thereof must meet in order to be compliant and often detail maximum concentrations tolerated in articles. An example of which is the eight polycyclic aromatic hydrocarbons (PAHs) in entry 50 of the list of restrictions, the amending regulation (EC no 1272/2013) and more specifically restriction number 5. This restriction gives an upper limit for the presence of PAHs in articles if any of their rubber or plastic components come into direct as well as prolonged or repetitive short-term contact with the human skin or oral cavity. Note the restriction had a phase-in period and entered into force on 27 December 2015 and the Commission will review the limit values in light of new scientific information. A consolidated list of restrictions, including updates to the restrictions through new EU amendment regulation (one of the RHS columns) can be found on ECHAs website. The list of restrictions imposes legal obligations and ensuring the restrictions are not breached is necessary to avoid enforcement action. Entries in the list of restrictions may or may not also appear on the CL and Annex XIV.
Due to the recent European Court of Justice ruling on 10 September 2015, the term article must be interpreted as the finished article and all its constituent articles from which it is comprised, this affects the interpretation of Articles 7(2) and 33 above. In practice this means that the SVHCs must be notified and communicated on both the finished article level and on the individual component level. Those dealing in complex products i.e. cars, laptops, submarines etc. are most affected. ECHAs official Guidance on requirements for substances in articles is due to undergo more significant updates in the near future in view of the court ruling.
REACH is enforced by Member States Competent Authorities and so there can be some discrepancies between enforcement actions, although the Forum for Exchange of information on Enforcement is a body aimed at standardising enforcement procedures. Some CAs may be more proactive than others. Germany enforces REACH at a state level and so enforcement action can vary between regions within the country. Since REACH is a regulation and not a directive, it is directly transposed into member states without the need to be implemented through the courts and so the obligations that legal entities in different legal states are under, due to REACH, are the same. Further to this, Member States may also have additional legislation to REACH with which compliance is required if businesses are operating in their jurisdiction.
REACH is extensive and complex legislation, identifying obligations and meeting them is no small feat. REACHReady is here to help you help your business ensure compliance with REACH, BPR and CLP through our many service offerings. Gold Subscribers, for a small fee, enjoy access to an expert staffed, highly responsive Helpdesk; receive regular Technical Alerts that draw attention to developments in the regulations; benefit from discounted workshops; receive monthly REACHReady Review; and reap the rewards from many other services. Visit REACHReady or email firstname.lastname@example.org to find out more.