Friday, April 18, 2014

How to: REACH authorisation for aviation industry

A new, joint ECHA and European Aviation Safety Agency (EASA) publication covers primary aspects of the REACH authorisation process:
  1. Definition of the uses to apply for
  2. Need for extensive supply chain communication
  3. Analysis of alternatives
  4. Socio-economic analysis 
The report includes best practices for efficient communication in the supply chain.


ECHA wishes to recognize the complexity of interactions between the many manufacturing levels and the numerous competitors in this strategic industry sector. The report is important for the aviation industry because REACH authorisation is considered as a "mission-critical" process. The reasons are mainly due to the regulatory controls associated with the introduction of alternative chemicals; the industry's dependence on certain substances of very high concern (SVHC), the relatively small volumes of SVHCs in use and the complexity of its supply chain. Answers developed may be applied to other industries as well, though the analysis is based on the specific case of the aviation industry.

Get the report here: http://echa.europa.eu/documents/10162/13552/aviation_authorisation_final_en.pdf

Chemical identity overhaul

Unambiguous substance identification is a pre-requisite to most of the REACH processes. Actors in the supply chain must have sufficient information on the identity of their substance.
Who am I?

Recently, ECHA has initiated a program designed to update substance identity information. Expect inquiries from the agency. It may turn out that substance identities will significantly change. There is no way to know yet, but it's important to keep an eye on this as it unfolds.

The correct identification of a substance will enables:
  1. Information sharing by potential registrants and data holders to prevent the duplication of testing on animals and unnecessary costs
  2. The assessment of the applicability of test data across companies who registered the same substance, the assessment of read-across proposals (categorisation approach) or the use of non test information
  3. The assessment if a substance is included in the Authorisation List, the list of restrictions or if its classification and labelling has been harmonised
The following information on the manufactured or imported substance shall be included in the dossier in order to unambiguously identify the substance:
  1. Substance name and related identifiers, molecular and structural formulae, if applicable
  2. Information on the composition and purity of the substance
  3. Spectral data and analytical information to verify the identity and composition of the substance
  4. Clear and concise description of the analytical methods

Wednesday, March 12, 2014

New chemical intentions and submissions

The European Chemicals Agency (ECHA) has announced new intentions and submissions of chemicals. Newly announced are:
  • SVHC: four new SVHC submitted intentions
  • CLH: two new intentions and five new submissions
  • Restriction: one new restriction from Germany
- SVHC -
Four new submitted SVHC intentions have been published in the Registry of Intentions. Denmark has withdrawn an SVHC intention for Sodium perborate. It has been included in the submitted SVHC intention for Perboric acid, sodium salt (EC 234-390-0).

The four submissions are:
  1. 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear
  2. Cadmium chloride
  3. Perboric acid, sodium salt; sodium perborate
  4. Sodium peroxometaborate  
Reference link here.

- CLH -
Two new intentions and five new submissions for harmonized classification and labeling have been added to the Registry of Intentions. The new intentions are:
  1. Silver zinc zeolite 
  2. 2-(4-tert-butylbenzyl)propionaldehyde 
The new submissions are:
  1. terbuthylazine
  2. chlorsulfuron
  3. N,N-diethyl-m-toluamide
  4. deet
  5. glass fibres of representative composition and E-glass fibres of representative composition
A CLH proposal for 2-(4-tert-butylbenzyl)propionaldehyde has been withdrawn by the dossier submitter. The dossier submitter intends to include results from a study requested under CoRAP in a revised CLH proposal. This substance has been included in the list of CLH intentions.

Reference link here.

- Restriction -
A new restriction intention has been published in the Registry of Intentions. Germany, in cooperation with Norway, plans to submit an Annex XV Restriction dossier on Perfluorooctanoic acid (PFOA) by October 17, 2014.

Reference link here.

Thursday, February 27, 2014

ECHA's annual evaluation

ECHA's annual evaluation report 2013 gives recommendations to all REACH registrants on how to improve the quality of their dossiers.

The agency points out that in 2013 they forwarded 32 non-compliant cases to national enforcement authorities for their action.

Here's the report of review results and recommendations:
http://echa.europa.eu/view-article/-/journal_content/title/reach-evaluation-report-2013-results-and-recommendations-from-dossier-evaluation

A stat of interest: Altogether, ECHA has checked 1,130 dossiers –exceeding the 5 % target of the total number of dossiers submitted for the registration deadline in question. I

n 61 % of the cases concluded in 2013, ECHA found that the dossiers did not comply with one or more REACH information requirements. Draft decisions were sent to the registrants.

Wednesday, February 12, 2014

5 new REACH SVHCs for authorization

ECHA has recommended a new batch of substances for authorization to the European Commission.

The recommended substances are:
  1. N,N-dimethylformamide (DMF) 
  2. diazene-1,2-dicarboxamide (C,C'-azodi(formamide)) (ADCA)
  3. Aluminosilicate Refractory Ceramic Fibres (Al-RCF)
  4. Zirconia Aluminosilicate Refractory Ceramic Fibres (Zr-RCF)
  5. 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-Octylphenol ethoxylates) (4-tert-OPnEO)
All five are currently on the REACH Candidate List for Authorization. Four of them have hazardous properties for human health being classified as carcinogenic, toxic for reproduction, or respiratory sensitizers. The fifth entry comprises an SVHC which has effects to the environment due to its degradation into a substance with endocrine disrupting properties.

If you are interested in how software can keep your company product data discreet while ensuring regulatory compliance, it may make sense to request information from software companies about possible ROI for your company using a REACH compliance automation system. If you are interested in a cloud/SaaS solution for REACH, Actio is one we know of that works, but there are others.


Thursday, January 2, 2014

7 new substances on REACH Candidate List

On Dec. 16th, 2013 ECHA added seven new substances to the the REACH regulation Candidate List. This is not hugely surprising, but a December addition always catches people off-guard. It's right in the middle of "the" primary Western Hemisphere holiday season and generally a fiscal year-end. Suddenly we're reminded of what we must do in January. In January we, always, update compliance efforts.

The 7 substances added in December are:
  1. Cadmium sulphide, CAS #1306-23-6
  2. Disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28), CAS #573-58-0
  3. Disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38), CAS #1937-37-7
  4. Dihexyl phthalate, CAS #84-75-3
  5. Imidazolidine-2-thione (2-imidazoline-2-thiol), CAS #96-45-7
  6. Lead di(acetate), CAS #301-04-2
  7. Trixylyl phosphate, CAS #25155-23-1
Legal obligations are well-articulated on this page, see bottom, subtitled "Your legal obligations" or just click that link.

The list of chemicals on the Candidate List is currently at 151. A full REACH regulation candidate list is available on the ECHA website. You can also usually get one from your own trusted data and regulatory entities.


Tuesday, December 17, 2013

What are Future SVHCs Under REACH Regulation?

Now business folks can monitor progress on the implementation of the SVHC Roadmap. This is a helpful tool.

A designated section on ECHA's website provides regularly updated information on how the Agency, the European Commission and the EU Member States plan to implement the SVHC Roadmap to 2020.

This Roadmap aims to have all relevant substances of very high concern (SVHCs) included in the Candidate List by 2020. You can view information on substances of potential concern here.

If this area is of interest to you, bookmark the following page on the ECHA official web site: http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern