12th October 2016
Dear reader,
It’s becoming traditional for the EU to issue a flurry of regulations in June and July before the Continent shuts down for most of August, and 2016 followed this pattern.
I had just managed to send out our previous newsletter, which included some information on the 8th ATP to CLP, available here https://ttenvironmenta.wpengine.com/newsletter-25-comah-and-reach-news-8th-atp-to-clp-and-brexit/, when the bureaucrats at the European Commission decided to publish the 9th ATP, so I thought I’d collate the rest of my analysis of the 8th ATP to CLP with a review of the 9th ATP. Our next newsletter will be on non-CLP topics!
8th ATP to CLP – further thoughts
As I mentioned in our previous newsletter, the 8th ATP to CLP has been published at http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0918&from=EN
Having gone more deeply into the changes to corrosive to skin, there are several significant changes which may affect many chemicals classified as substances, and mixtures containing these substances.
Substance classification for skin corrosion and irritancy
Prior to the 8th ATP, CLP has contained 1 category of Skin Corrosion, Skin Corr 1, and 3 sub-categories of skin corrosion, that is Skin Corr 1A, 1B and 1C.
However, Skin Corr 1 has not been used as a classification in its own right. Under the 8th ATP to CLP, Skin Corrosion 1 can now be used where there are corrosive effects (still defined as ) but not enough data to assign a sub-category, increasing the number of skin corrosion possibilities from 3 to 4. The definitions of skin irritancy remain unchanged.
At the same time as clarifying that the Skin Corr. 1 category can be used in certain circumstances, the definitions for all skin corrosion categories and sub-categories have been altered significantly.
Originally, the definition of skin corrosion, whether as Skin Corr 1 Category 1, or sub-categories Skin Corr 1A, 1B or 1C was on corrosive effects appearing in at least 1 in 3 animals. This has been changed in the 8th ATP to corrosive effects appearing in a single animal. (As far as I can tell, all the other parts of the definition, e.g. exposure time, response time, and definition of response remain unchanged).
This is likely to bring some substances currently classified as irritant into scope as corrosive.
In practice, everyone who has classified a substance on the basis of data as Skin Irrit 2, or who suspects there may be skin irritant or corrosive effects, will have to review their data to see whether it now meets the new skin corrosive definitions.
Similarly, anyone using Skin Irrit 2, H315 materials in their mixtures should be aware that this classification might change, and be prepared to re-classify their mixtures if required. For consumer product companies who are anxious to avoid the Skin Corrosive classification, this might involve re-formulation of affected mixtures. (This review process will not be required for mixtures which have been tested in their own right and shown to be irritant, as this definition is unchanged).
The deadline for compliance with the 8th ATP to CLP is 1st February 2018, so it may take several years for these changes to work their way through the supply chain.
Substance classification for eye damage and irritancy
The definitions of eye damage and eye irritation for substance classification (methods, thresholds etc) are basically unchanged, although reference is briefly made to accepted non-animal test methods being allowed.
Mixture classification for skin corrosion and irritancy
This process is essentially the same as before, although references to the new Category 1 Skin Corr are included alongside the sub-categories.
Mixture classification for eye corrosion and irritancy
This is also essentially the same process as before, however Table 3.3.3,” Generic concentration limits of ingredients classified as skin corrosion (Category 1, 1A, 1B or 1C) and/or serious eye damage (Category 1) or eye irritation (Category 2) that trigger classification of the mixture as serious eye damage/eye irritation where the additivity approach applies” has been altered.
Instead of listing 5 specific limits, with corresponding algorithms, where skin corrosion and/or eye corrosion may combine to give eye corrosion and irritancy, this has been simplified to 3 specific limits, so that instead of 5 algorithms, there are now only 3 algorithms. However, the overall classification effects remain the same, as far as can be ascertained, and this is just a way of simplifying the arithmetic.
If you have been on one of our CLP training courses over the past few years and would like a complimentary copy of the updated skin corrosion substance and eye corrosion substance and mixture classification worksheets, please email me.
9th ATP to CLP
The 9th ATP to CLP can be downloaded from http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R1179&from=EN .
As I said in our previous newsletter, there were no changes to Harmonised Classifications in the 8th ATP, but I should have known that this calm state of affairs couldn’t last!
The 9th ATP includes a total of 50 changes to the Harmonised Classifications (details below), and also provides for Table 3.2 in CLP, which contains the CHIP Harmonised Classifications, to be removed on the 1st June 2017, which is the date by which all mixtures placed on the EU marketplace should be labelled and classified using CLP, and CHIP labelling and classification becomes defunct.
2 Harmonised Classifications have been deleted, 22 Harmonised Classifications have been altered, 26 new Harmonised Classifications have been added. A list of all the affected substances, with their CAS numbers, is available to download https://ttenvironmenta.wpengine.com/list-of-substances-with-changed-harmonised-classifications-made-in-9th-atp-to-clp/ .
An extended version of this list with detailed notes of the relevant changes is available for anyone who has either been on our CLP training course, or is a COMAH client of ours, please email me for a copy.
We have also produced an updated version of Table 3.1 from Annex VI to CLP in Excel® including the 9th ATP changes, which is also available to our CLP training course attendees. The reason for producing this is because it is likely that the updated version of the excel file will not be available from ECHA until 1st March 2018, the current version is at http://echa.europa.eu/information-on-chemicals/annex-vi-to-clp. (By the way, if you are not a client of ours, but would like a copy of these documents anyway, please email me to discuss).
As I’m sure you’re aware, in theory these Harmonised Classifications come into force on 1st March 2018, but under Duty of Care in the UK, we are supposed to update classifications as soon as practicable once we receive relevant new information.
Don’t forget that modern Harmonised Classifications don’t necessarily cover all of the risks from a hazardous chemical, so you may need to check e.g. REACH registrations to ensure all of the relevant “end points” have been covered.
As well as checking whether any classifications of substances or mixtures on your site may be affected, don’t forget to update your COMAH liability classification where there have been relevant changes caused by this set of updates. Our Sevaluate program can help you keep track of this type of change https://ttenvironmenta.wpengine.com/comah/sevaluate/.
Proposed updates to CLP classification guidance
As you might expect, the significant changes in the CLP regulation due to the 8th ATP mean that the classification guidance needs to be updated.
The DRAFT of the updated Guidance is directly & freely available on the ECHA website:
Part 1 is at http://echa.europa.eu/documents/10162/13643/clp_guidance_draft_v5_part1_en.pdf (note incorrectly says July 2017 on cover)
Part 2 is at http://echa.europa.eu/documents/10162/13643/clp_guidance_draft_v5_part2_en.pdf (note incorrectly says July 2017 on cover)
Part 3 is at http://echa.europa.eu/documents/10162/13643/clp_guidance_draft_v5_part3_en.pdf
The drafts have been sent to PEG, the “Partner Expert Group” see https://echa.europa.eu/documents/10162/13608/mb_63_2013_revision_consultation_procedure_guidance_en.pdf which explains the process.
Many thanks to the late and much-missed Desmond Waight of Dangoods for this article, originally published in the LinkedIn Group “CLP Regulation EC No 1272/2008” https://www.linkedin.com/groups/3572650 .
I hope this information is useful, and if you need any help with CLP, please contact me on 01422 24 22 22, or on janet@ttenvironmental.co.uk
Kind regards,
Janet
P.S. We are running our Intensive CLP training course on Thursday 3rd and Friday 4th November 2016, 2 places left, 2-day-intensive-clp-course-from-tt-environmental-ltd , email me to book or for further information.
Janet Greenwood
TT Environmental Ltd
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Disclaimer: The advice we can give in newsletters like this is generic, and given in good faith based on our understanding at the time of writing. You should check your own situation, and any applicable regulations, before deciding whether to take any actions based on advice in this newsletter.
Download a pdf version of this newsletter here: tte-newsletter-no-26-12-10-2016
