It can be difficult to keep track of everything which comes out of ECHA, and frankly sometimes I wish they had a colour coding system for their updates and newsletters.
For example, they often make a big fuss about a proposed change, such as an SVHC going through a particular committee, and then the actual regulation change isn’t given such prominence, and you might miss it if you don’t keep on top of things.
It would be nice if they could do a traffic light system:
- green – something fluffy and unimportant, such as their internal news
- amber – something that may affect industry, but not yet (such as SVHCs or restrictions going through committee stages)
- red – real changes which will affect industry, such as regulatory changes
You can probably guess that I’m suggesting this because, yet again, something important to industry has been slipped out without much fanfare. In fact, I almost called this newsletter “Under the Radar”, because I’ve lost track of the times I’ve used the term “under the radar” to describe how chemical regulation updates are released from the EU!
This time, it’s about where the UFI should go on the CLP label. and about the Poison Centre Notification deadline being pushed back, amongst other things.
There has been an amendment to CLP (but not a formal ATP), called “Commission Delegated Regulation (EU) 2020/11 of 29 October 2019, amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards information relating to emergency health response”
An official decision has been made that the UFI should go in the supplementary information on the label. You may think that this is the blindingly obvious place to put the UFI, as this is compliant with GHS, and where all of the “other” information is supposed to go, but the initial guidance from ECHA had placed it near the symbols! Speaking as a nerd, it’s something which has bothered me since Annex VIII guidance was issued, so I’m very glad that this inconsistency has now been resolved.
The only reason I found out about this was a brief announcement by someone who works at the ECHA Helpdesk on LinkedIn, here, and the actual piece of amending regulation is available here. There was no news item at ECHA, although to be fair the announcement may have appeared in an ECHA newsletter. (Having said that, the only ECHA newsletter I’m signed up to just says what the recent news items are).
And what’s really irritating me is that although the date in the main part of the document is 29th October 2019 (page 1), and the implementation date is given as 1st January 2020 (page 2), the publication date of the document, which is given in the header at the top right hand part of the page is 10.1.2020. that is 10th January 2020 (all pages).
You could not make it up. Now the EU is publishing regulatory updates after the date they are due to come into effect. You’d have thought they would at least have altered the other dates to make it logical (that’s definitely my inner nerd speaking).
And that’s not the only piece of important information in this update. It also contains the official ruling that the first Poison Centre Notification deadline has been put back to 31st December 2020, or 1st January 2021, to use ECHA-speak.
At least this explains why we haven’t been able to find the official regulation putting back the first Annex VIII deadline. There were references on the Poison Centre website itself, but nothing in a regulation to state that it was definitely postponed. A lot of people needed that piece of information for their bosses, but there was nothing concrete to show them. No wonder we couldn’t find the regulation change, it was because it wasn’t published until the New Year! If you are in this position, at least you can show your managers that it’s genuinely been postponed.
The new Part A, Section 1.1. reads “1.1. Importers and downstream users placing on the market mixtures for consumer use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.”
As you might expect, there are other alterations to Annex VIII to CLP in this update as well:
- A formal definition of mixture components has been added to Section 3.2 “A mixture component is either a substance or a mixture in mixture“. This means that references to “components (substances or mixtures in mixtures)” are now simply “components”
- The term fragrances has been omitted, so now only perfumes are referred to (I’m not sure what the technical difference is between the two, so this may be a meaningful change, or not)
- For group submissions, the requirement that mixtures need to belong to the same product category has been dropped
- The formal requirement to place the UFI on the supplemental portion of the label, or elsewhere on the package has been included.
- There is a clarification that the UFI must go onto the SDS where notified industrial mixtures are transported in bulk; and that notified mixtures which are only used industrially may place the UFI on the SDS instead of the label as a derogation
- It is recognised that a mixture may be sold under more than one trade name, and that all the names must be submitted as part of the notification
- The pH requirements have been explained in more detail: “the pH, if available, of the mixture as supplied, or, where the mixture is a solid, the pH of an aqueous liquid or solution at a given concentration. The concentration of the test mixture in water shall be indicated. If the pH is not available, the reasons shall be given“
- It is clarified that anyone submitting limited details for industrial mixtures must also provide access to 24 x 7 hazardous information support, in the language of the country where it is supplied
- There is now the ability to include contact details for providers of hazardous information separate from the submitter. This can presumably be a contact point within in your organisation, or an external provider
- There is more information on the information which needs to be provided where you are notifying a Mixture in Mixture component which has not already been notified in its own right “In absence of a UFI or if the appointed body has not received the information on the MIM in a prior submission, the MIM shall be identified by means of its product identifier in accordance with Article 18(3) (a), together with its concentration and the compositional information contained in the Safety Data Sheet of the MIM and any other known components, as well as the name, email address and telephone number of the MIM supplier“. However it is also clarified that only the physical and health hazards of an MIM need to be notified: “In the case of a MIM identified by means of its product identifier and its UFI in accordance with Section 3.2.2 of Part B, only the classification for health and physical hazards of the MIM shall be provided“
There are also three changes to CLP itself:
- stating explicitly that the UFI should be placed in the supplemental information portion of the label (Article 25)
- but adding a derogation that it can be placed elsewhere on the package in accordance with Annex VIII (Article 29)
- and bringing this regulation updating Annex VIII into effect
As usual, if you are affected by these changes, you should check the update yourself. I have tried to find a consolidated version of Annex VIII, but there does not seem to be one available at the moment.
So there you are, yet more changes which we have not been properly informed about. And at the same time, ECHA continues to take on more duties, most recently they will compile a list of substances that can be safely used in materials that come into contact with drinking water, see here.
This is frustrating when it seems to me that they can’t keep on top of their core responsibilities at times (it’s not just informing industry properly of changes; it’s also the ongoing IT problems with not all REACH registrations being picked up by the Classification and Labelling inventory; and the inconsistencies in responses to Inquiries which have occurred recently).
Of course, being surprised by extra pieces of legislation may be my fault for not keeping track of things properly, but most of us in the chemical industry seem to be trying to do the work of at least two people, and it’s getting harder for us to keep on top of things (and don’t mention the amount of time and effort we’re all spending on guessing what’s going to happen when the UK goes through Brexit….)
So, come on, ECHA, get your act together and give industry better information on the actual regulatory changes which are being made.
GHS Classification Courses from TT Environmental Ltd
20th January 2020
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P.S. You may have noticed that, as I predicted here, 4 new SVHCs have been identified by ECHA this month, and I’ll discuss these next week.