11 New Authorisations, February 2020

It looks like ECHA are going to be really busy in their new home.

The European Commission, not content with bringing in 4 new SVHCs in January, have now moved 11 existing SVHCs into full Authorisation.

These are the first new Authorisations since 2017, so it’s rather like buses – you wait for ages, and then several come along at once!​

Several existing Authorisation periods have been extended for a very specific use in spare parts (see below), to allow certain substances with this specific use longer Application and Sunset dates than initially approved, although their main Application and Sunset dates are unaffected.

If you are handling the substances concerned, either as individual substances or in mixtures, you need to make plans about what to do about them now, in order to make sure you have stopped using them, or have obtained an Authorisation for your use, by the Sunset Date (which is usually unique to each Authorised Substance).

Of course, some uses are exempt from Authorisation. There are some generic exemptions which apply to all Authorised substances listed here: https://echa.europa.eu/documents/10162/13640/generic_exemptions_authorisation_en.pdf/9291ab2a-fe2f-418d-9ce7-4c5abaaa04fc, and there are sometimes specific exemptions for an individual substance listed in the individual Authorisation documents, which means that if you have a substance which is subject to Authorisation, it pays to read the small print very carefully.

What Authorisation means in practical terms is: it’s going to cost you.

• you need to spend time (and money) checking if your substance is Authorised, and, if it is, whether an exemption applies to your use
• if your substance is liable for Authorisation, you will have to apply for an Authorisation, or use a supplier who has obtained an Authorisation (which will cost more than before the Authorisation), by the latest Application Date
• and if you haven’t got an Authorisation, and still have some left after the Sunset Date, your only option is disposal of the substance or mixture containing the substance, and this is almost inevitably going to be disposal via incineration, and therefore expensive

So let’s dive into the details of the new Authorisations, and the extensions to existing Authorisation periods.

New Annex XIV update to REACH

As you probably already know, Authorisation is covered under Annex XIV of REACH, List of Substances Subject to Authorisation, and in order to bring in a new Authorised Substance, this list needs to be updated.

This latest update to Annex XIV of REACH is called “COMMISSION REGULATION (EU) 2020/171 of 6 February 2020 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)“.

It was adopted on Thursday 6th February 2020, and will come into force 20 days later, that is on the 26th February 2020. However, this is just the date at which the update comes into force, and is not the actual Sunset dates for any of the new Authorised Substances.

It can be downloaded from here in all the EU official languages, and the English language pdf version can be downloaded from here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0171&qid=1581183006065&from=EN .

11 new Authorised Substances

These are new entries 44 to 54 on the Authorisation List:

44. 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear, CAS No: 68515-50-4

45. Dihexyl phthalate, CAS No: 84-75-3

46. 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with≥ 0,3 %of dihexyl phthalate (ECNo 201-559-5), CAS Nos: 68515-51-5; 68648-93-1

47. Trixylyl phosphate, CAS No: 25155-23-1

48. Sodium perborate; perboric acid, sodium salt, EC No: 239-172-9; 234-390-0 (no CAS no given)

49. Sodium peroxometaborate, CAS No: 7632-04-4

50. 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1- yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2- (4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any com­ bination thereof] (no EC or CAS nos given).

51. 2-(2H-benzotriazol-2-yl)-4,6-ditertpentyl­phenol (UV-328), CAS No: 25973-55-1

52. 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320), CAS No: 3846-71-7

53. 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2- yl)phenol (UV-327), CAS No: 3864-99-1

54. 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6- (sec-butyl)phenol (UV-350), CAS No: 36437-37-3

Note that there are no exempted categories of uses for any of these Authorised substances.

For details of the latest Application Dates and Sunset Dates, see the update to Annex XIV.

Change to the Notes below the Authorisation List in Annex XIV of REACH regulation

The current Consolidated Version of the REACH regulations was issued dated 01-01-2020, and can be downloaded here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R1907-20200101 

These notes refer to Application Dates and Sunset Dates “for the use of the substance in the production of spare parts for the repair of articles the production of which ceased or will cease before the sunset date indicated in the entry for that substance, where that substance was used in the production of those articles and the latter cannot function as intended without that spare part, and for the use of the substance (on its own or in a mixture) for the repair of such articles where that substance on its own or in a mixture was used in the production of those articles and the latter cannot be repaired otherwise than by using that substance.”

There is an extension from Application Dates of 1st September 2019 to 1st September 2021; and Sunset Dates from 1st March 2021 to 1st March 2023, for substances in the production of spare parts meeting these criteria.​

In plain language, the legal text means “for use in the production of spare parts where no substitutions are legally or practically possible”, and applies mainly to the aerospace industry.

Aircraft have a 20 year lifespan, and all of their components are tested rigorously before being allowed to be used.  They must be replaced on a strict “like for like” basis, including not just the component, but how it was manufactured, e.g. if it’s a metal component which has been treated by a specific chemical process like chrome plating, this must be exactly the same as for the initial tested component.

So if you want to change how that aircraft component was made, you need to get the component made in the new way (e.g. by using a different metal treatment process), and then it needs to be tested to the same standards as the existing process.  If it passes those tests, then it can be used as a spare part in the aircraft concerned.

This incredibly strict process is because of aircraft safety standards, and because it’s so long, you can see why the Application and Sunset Dates for chemicals used in the aerospace industry need to be longer than for ​chemicals used in other applications.  (Whether Authorisation is an appropriate tool for chemical risk management is a topic for a different newsletter!).

Extension to 12 existing Authorisations’ Application and Sunset Dates

These new Application and Sunset Dates, for use in specific spare parts, apply immediately from entries numbers 44 to 50 (see above), and retrospectively to Authorisation List Entries numbers 32 to 43, that is:

32.1-Bromopropane (n-propyl bromide), CAS No: 106-94-5

33. Diisopentylphthalate, CAS No: 605-50-5

34.1,2-Benzenedicarboxylic acid, di-C6-8-branched al­kyl esters, C7 rich, CAS No: 71888-89-6

35.1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters, CAS No: 68515-42-4

36.1,2-Benzenedicarboxylic acid, dipentylester, branched and linear, CAS No: 84777-06-0

37.Bis(2-methoxyethyl) phthalate, CAS No: 117-82-8

38. Dipentylphthalate, CAS No: 131-18-0

39. N-pentyl-isopentylphthalate, CAS No: 776297-69-9

40. Anthracene oil, CAS No: 90640-80-5

41. Pitch, coal tar, high temp., CAS No: 65996-93-2

42. 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (covering well-defined su­ stances and UVCB sub­ stances, polymers and homologues), no EC number or CAS number given

43. 4-Nonylphenol, branched and linear, ethoxylated (substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in pos­ition 4 to phenol, ethoxy­lated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof), no EC number or CAS number given

All of these substances benefit from the “use in spare parts” extension of their Application Dates to 1st September 2021, and Sunset Dates to 1st March 2023, but for all other uses, the original Application Dates and Sunset Dates remain the same.

So that’s the gist of the Authorisation changes. As usual, if you have any queries about this, please email me.

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10th February 2020

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