Imminent decision on the formal amendment of Annex XIV of REACH
Imminent decision on the formal amendment of Annex XIV of REACH – The Authorisation List
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State of play
On 8 December 2016, the EU REACH Committee voted in favour of a draft act proposing the addition of 12 substances to the REACH Authorisation list. The act, available here, is currently undergoing a compulsory three month scrutiny period by the EU’s co-legislators, the European Parliament and Council and it is likely that a final decision will be published very soon.
Proposed additions to REACH Authorisation Annex XIV | |||
Substance | Intrinsic property(ies) referred to in Article 57 |
Latest application date | Sunset date |
1-Bromopropane (n-propyl bromide)
EC No: 203-445-0 CAS No: 106-94-5 |
Toxic for reproduction (category 1B) |
[Date of entry into force + 18 months] | [Date of entry into force + 36 months] |
Diisopentylphthalate
EC No: 210-088-4 CAS No: 605-50-5 |
Toxic for reproduction (category 1B) |
[Date of entry into force + 18 months] | [Date of entry into force + 36 months] |
1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7 rich
EC No: 276-158-1 CAS No: 71888-89-6 |
Toxic for reproduction (category 1B) |
[Date of entry into force + 18 months] | [Date of entry into force + 36 months] |
1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters
EC No: 271-084-6 CAS No: 68515-42-4 |
Toxic for reproduction (category 1B) |
[Date of entry into force + 18 months] | [Date of entry into force + 36 months] |
1,2-Benzenedicarboxylic acid, dipentylester, branched and linear
EC No: 284-032-2 CAS No: 84777-06-0 |
Toxic for reproduction (category 1B) |
[Date of entry into force + 18 months] | [Date of entry into force + 36 months] |
Bis(2-methoxyethyl) phthalate
EC No: 204-212-6 CAS No: 117-82-8 |
Toxic for reproduction (category 1B) |
[Date of entry into force + 18 months] | [Date of entry into force + 36 months] |
Dipentylphthalate
EC No: 205-017-9 CAS No: 131-18-0 |
Toxic for reproduction (category 1B) |
[Date of entry into force + 18 months] | [Date of entry into force + 36 months] |
N-pentyl-isopentylphthalate
EC No: – CAS No: 776297-69-9 |
Toxic for reproduction (category 1B) |
[Date of entry into force + 18 months] | [Date of entry into force + 36 months] |
Anthracene oil
EC No: 292-602-7 CAS No: 90640-80-5 |
Carcinogenic (category 1B)***, PBT, vPvB |
[Date of entry into force + 21 months] | [Date of entry into force + 39 months] |
Pitch, coal tar, high temp.
EC No: 266-028-2 CAS No: 65996-93-2 |
Carcinogenic (category 1B), PBT, vPvB |
[Date of entry into force + 21 months] | [Date of entry into force + 39 months] |
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
[covering well-defined substances and UVCB substances, polymers and homologues] |
Endocrine disrupting properties for the environment (Article 57(f)) | [Date of entry into force + 24 months]
|
[Date of entry into force + 42 months]
|
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] | Endocrine disrupting properties for the environment (Article 57(f))
|
[Date of entry into force + 24 months] | [Date of entry into force + 42 months] |
Next steps
If you manufacture these substances and your downstream users are located in the EU or if you are actually a user of one of these substances, the time to act is now. Early preparation is key to the development of a successful authorisation strategy, whether you will be acting as an applicant yourself, seeking clarification that your use falls under an exemption, or supporting an upstream application.
If you need an authorisation, regardless of the approach you adopt, interdepartmental collaboration at an early stage will be a cornerstone to your success. There is no getting away from the need to submit (or support the submission of) authorisation application documents of a highly technical nature. The collection of detailed information on relevant uses, potential alternatives, risk management measures and actual data on emissions and exposures will also be key to ensuring that your use(s) will be properly covered, and that you will obtain the best possible review period outcome. As nobody knows your processes better than your production engineers, or understands your customer requirements better than your sales team, it is vital to make sure you get the whole team on board and aware of the authorisation process and its requirements.
If you intend to apply for authorisation as an upstream applicant and your supply chain is complex and not fully visible, there will certainly be a benefit in undertaking supply chain mapping activities. The nature of downstream use parameters can often be more complex than originally envisaged and obtaining a comprehensive overview of the downstream situation will also mean that initial strategies can be developed based on up-to-date information. Importantly, this can also help to limit the need for significant additions / changes to be made to documents at later stages.
It is also apparent that that ECHA’s risk assessment and socio-economic analysis committees wish to see ‘representative’ downstream worker exposure scenarios and early engagement may help ensure that there is time to gather such information or, where necessary, generate the details required for the downstream supply chain. The better the quality of the exposure data, the more convincing is the case that can be made to the ECHA Committees, in order to gain a ‘long’ review period.
With particularly complex supply chains, it is also important that applicants allocate sufficient time and resources to putting the required mechanisms in place (legal agreements, etc.) and selecting competent service providers, such as authorisation project managers capable of handling confidential information and dealing with conflicting interests, as well as those with the technical expertise, experience and capacity to deliver the required outputs.
Authorisation services offered by RPA
RPA has been at the forefront of REACH Authorisation since its inception and has been or is involved in the preparation of Applications for Authorisation for eight substances and 26 uses on behalf of 34 different applicant companies, as highlighted in the following table.
Substance | #Uses | Client | RPA Action | Submission | Status |
Bis(2-ethlyexyl) phthalate (DEHP) | 5 | 5 companies | AoA & SEA Peer review of Application | 2013 | Authorisations granted: one for 7 years, two for 4 years
Authorisations pending: three recommended for 4 years |
Dibutyl phthalate (DBP) | 3 | 2 companies | AoA & SEA | 2013 | Authorisations granted: three for 12 years |
Trichloroethylene (TCE) | 1 | 2 companies | AoA & SEA | 2014-2018 | Authorisations granted: one for 12 years
In preparation: one review report |
Chromium trioxide & sodium dichromate | 7 | 14 companies | AoA & SEA | 2015-2016 | Authorisations pending: nine recommended for 12 years; one recommended for 10 years (as requested by applicant) |
Ethylene dichloride (EDC) | 8 | 9 companies | AoA & SEA | 2015-2016 | Authorisations granted: one for 12 years
Authorisations pending: six recommended for 12 years; one recommended for 4 years (as requested by applicant); one still at draft opinion stage (delayed by ECHA) |
PBT substance | 1 | 1 company | AoA & SEA | 2018/2019 | In preparation: undertaking a Scoping & Strategy Study |
Endocrine disrupting substance | 1 | 1 company | AoA & SEA | 2019 | In preparation: undertaking a Scoping & Strategy Study |
8 substances | 26 | 34 companies |
Our clients range from major global sector groups to individual company applicants (both large and small-to-medium enterprises), and from manufacturers to downstream users. We have supported consortia with related but varying uses, as well as group applications with identical production processes. We are also frequently called upon by consortia managers to help their consortia formulate meaningful arguments that will have an impact on decision-makers, for submission to public consultations under various REACH processes.
In relation to the imminent potential update of Annex XIV, we are experiencing a surge in demand for our services and are in talks with various parties with a strategic interest in these substances, with a number of contracts signed and pending. Should you be interested in using RPA’s Authorisation services we urge you to contact us as soon as possible. Our expert team is able to provide bespoke strategic and scoping activities to assess your authorisation needs.
On request, we are also able to provide multiple references from previous clients. Why not see for yourself what some of our clients have to say about us or download our REACH brochure:
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