Brace yourself – yet more chemical legislation is on its way from ECHA.
If you make or import articles in the EU, you will probably already be aware that there is an obligation to notify ECHA of this manufacture or importation if:
- the article contains an SVHC (Substance of Very High Concern) at or above 0.1% w/w
- and the article contains the SVHC at 1 tonne per annum or above
- notification has to be made no later than six months after the inclusion of the substance in the Candidate List.
This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
However, notification is not required:
- where the total SVHC imported is less than 1 tonne per annum
- where humans and the environment will not be exposed to the SVHC during use and disposal of the article (although appropriate instructions shall be supplied to the article recipient)
- the substance has already been registered for that use
For full details of duties on article manufacturers and importers, see https://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles. Notification is currently carried out via REACH-IT, or using IUCLID6, see https://echa.europa.eu/support/dossier-submission-tools/reach-it/notifying-substances-in-articles .
However, a new duty is about to be placed on article importers or manufacturers where an SVHC is present at or above 0.1% in the article, under the requirements of the Waste Framework Directive and the REACH regulation.
There is going to be a new legal requirement to notify articles containing SVHCs to the SCIP database, which will be a public database to be used by waste companies, so they are aware of which articles contain SVHCs, so that they can be disposed of appropriately. It will also be searchable by consumers, unlike the current notification which appears to be private.
SCIP stands for Substances of Concern In articles, as such or in complex objects (Products).
The proposed implementation period is:
- Autumn 2019: launch of a user test group and a stakeholder workshop at ECHA (preliminary date 12 November)
- Early 2020: launch of the prototype version of the database
- July 2020: deadline for Member States to transpose the legal requirements into national law
- 5 January 2021: notification duty kicks in for industry
SCIP recognises two types of products requiring notification:
- articles, that is individual products such as a cutting edge made from metal
- complex objects containing more than one individual article, such as a pencil sharpener with a plastic body and a metal cutting edge and a screw holding them together
The notification requirements are currently (voluntary information in italics):
- article name
- Other article names
- article identifier number (e.g. European Article Number, EAN, Global Trade Item Number (GTIN); Universal Product Code (GPC); Catalogue number; ECHA Article ID, part number)
- Other article identifiers
- article category
- whether made in the EU or not
- characteristic value
- characteristic unit
- Safe use instructions (although you can put ““No need to provide safe use information beyond the identification of the Candidate List substance”)
- Disassembling instructions
- Linked article (complex objects only)
- Number of units (complex objects only)
- Candidate List version
- Candidate List substance
- Substance name
- EC number
- CAS number
- Concentration range
- Material category (either this category, or Mixture category, or both are mandatory)
- Mixture category
This is a list of 11 mandatory and 10 voluntary pieces of information, and for manufacturers or importers with large product ranges, may prove to be a larger task than the regulators anticipate.
Many article manufacturers have product ranges in the thousands, and all of these will need to be checked for SVHCs. Add in the regular additions to the SVHC list, and you have a new, ongoing compliance requirement for article manufacturers analogous to the REACH registration burden for chemical manufacturers.
ECHA state that their aim is to move people to substitute SVHCs in articles, and given the burden of information, this will no doubt be an attractive option for many companies.
However, this approach fails to take into account substances which have been investigated and which have found to not have SVHC characteristics, but which are still on the SVHC list; or substances where there may be some disagreement over whether it really should be classified as an SVHC (as per the recent Titanium Dioxide Harmonised Classification discussions).
It also puts yet another red tape burden on companies who do not have a reliable substitute for a particular SVHC in their article. This is yet another example of ECHA behaving as if it is easy to substitute one chemical for another, as I discussed recently in my article on the “Magic Chemicals Tree“.
As well as adding to the EU manufacturing industry’s red tape burden, it is also not clear from the current ECHA guidance whether the SCIP provisions will apply to all articles containing SVHCs at or above 0.1% w/w; or whether it only applies to the current duty holders.
I have asked ECHA about this, and am currently waiting for a response, and will let you know as soon as I have received it.
Update, ECHA replied on 30th September 2019 as follows:
“Thank you for contacting the European Chemicals Agency (ECHA).
Article 9(1)(i) of the Waste Framework Directive 2008/98/EC (WFD) extends the REACH Article 33 duties of suppliers of articles to communicate, under certain conditions, information about the presence of Candidate List substances in their articles down the supply chain and to consumers (upon request) , by requiring them to submit that information also to ECHA.
There is no tonnage threshold for REACH Article 33(1) obligations (to which WFD refers). This is explicitly stated in section 3.2.1 of the Guidance on Requirements for Substances in Articles available here https://echa.europa.eu/documents/10162/23036412/articles_en.pdf. ”
So it looks like this requirement will apply to all articles containing SVHCs at or above 0.1% w/w. Update ends.
ECHA claim that the SCIP database will “improve transparency on hazardous substances in articles”, but this is disingenuous, as it only covers SVHCs, and not every single possible hazardous substance. This statement also fails to appreciate that hazardous substances in articles do not generally cause harm to the user of the article, and in many cases are unlikely to cause harm even when they are disposed of.
It is also part of the general movement, which we have seen within REACH, towards assuming that the end user, and in this case the waste industry professionals who will dispose of these articles, are idiots, who must be spoon fed information so that they don’t harm themselves.
This underlying assumption overturns the basis of trading laws in the UK, and presumably in the EU, which has worked perfectly well for millenia, and is summed up in the single Latin phrase “caveat emptor”, “let the buyer beware”.
Yet this micro-managing approach assumes that the seller of a chemical, or in this case an article, knows what the end use is going to be, which we know in the chemical industry is very far from the case. Trying to make industry and business responsible for every potential use their products are put to is going to end in tears, because of the amount of unknowns involved. It also penalises the law abiding, while having zero affect on the bandits.
And it also takes good experienced technical people away from their main job of making products safer, and wastes their time with red tape which gives consumers a false sense of security, because we can’t predict how they might misuse our products.
It is ironic that ECHA are pushing substitution as the “answer” to hazardous chemicals (despite the fact that we use chemicals because they are hazardous), yet the whole burden of chemical compliance is being met by the very people who could otherwise potentially find safer chemicals or safer ways of making or using existing chemicals.
In terms of the implementation of the SCIP database, this will obviously apply to all EU member states, but at the time of writing, we don’t know whether this will include the UK or not, due to the uncertainty around Brexit.
What is clear is that if the UK leaves the EU before the SCIP database is implemented, which is due to be by July 2020, then the duties will not apply in the UK itself, and the legal liability will fall on the importer of UK articles into the EU.
There do seem to be a lot of new regulations coming out of the EU at the moment, and I will do my best to keep you up to date.
GHS Classification Courses from TT Environmental Ltd
23rd September 2019
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