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Blog: REACH – ripple effects on the whole supply chain

An important milestone for the European chemical industry has been reached as the final REACH registration deadline for substances passed in 31.5.2018. The European REACH Regulation ((EC) No 1907/2006), however, continues to set high standards for the whole industry, from manufacturers, importers, formulators and distributors all the way down to downstream and end users.

Effects on the supply chain

Whilst the REACH registration deadline passed in 31.5.2018 already, it can take up to 3 months for the European Chemicals Agency ECHA to make a registration decision; your supplier might be fully REACH compliant if they have submitted their dossier on time, but might not yet have received a registration decision, i.e. a registration number, from ECHA. In complex cases where an extension might have been received from ECHA and the Director’s Contact Group, receiving a registration decision will take even longer than that.

This also means that the potential effects of the last registration deadline that mainly dealt with SMEs and their substances might affect supply chains with a delay. Whether or not the registering company had enough assets and know-how to pull through the registration might become evident only later on. If a company has decided to cease their manufacture by 31.5.2018, they are still allowed to sell all their supply gathered before the deadline to downstream users as distributors. Whether or not some companies or some products might be dropping out, or the market become more homogenized, will most likely be found out only after the dust of the final registration deadline has settled.

Communicating REACH compliance to authorities and stakeholders

In terms of supply chains and their continuance, it is important to notice that pre-registration numbers are no longer valid. It is also important to notice that either a generic or a company-specific version of the actual REACH Registration number can be put forward. The company-specific version always consists of four parts of numbers, e.g. 01-2119458769-17-0003, whereas the generic form might only consist of three (e.g. 01-2119458769-17 or 01-2119458769-17-XXXX). Make sure that your suppliers have actually registered the substance in their name, and are not just giving you a generic number to keep you content for a while.

A good way to communicate a company’s adherence to REACH and its many requirements is a REACH declaration of compliance. Such a statement can serve as a testimony to the authorities or as communication to customers and other stakeholders to show that your company is indeed REACH compliant in all the relevant aspects of the REACH Regulation. Such a statement is a hard asset outside of Europe as well.

A shift in focus towards formulators

As the burden of REACH has previously been mainly on substance manufacturers and EU importers, the focus of the regulation is now shifting towards formulators. The safe use of mixtures is a topic that will need to be addressed by operators in the coming years in the form of unique formula identifiers (UFI) and poison centre notifications (PCN). This will require a thorough knowledge of the composition and hazardous properties of the supplied mixtures as well. Exposure scenarios and their utilization in communicating the safe use of mixtures will surely be giving formulators some gray hair.

Increasing amount of regulation

As ECHA is now the holder of the world’s largest open database of substance information, plans on how to best utilize the gathered information on the registered substances are big. On a general level this might mean more substance restrictions and harmonized classifications. Manufacturers of highly hazardous substances or those who have submitted incomplete information, on the other hand, might become a target for even more scrutiny.

Reaching the legislative deadline will also most definitely result in increased supervision from national authorities on whether or not companies have fulfilled their various requirements under the REACH Regulation, with regard to substance restrictions and registrations especially. A more scrutinized assessment of SDS’s and of the responsibilities that downstream users have regarding exposure scenarios and their assessment against their own conditions could also result.

Harmonized classifications under the CLP Regulation ((EC) No 1272/2008) themselves can also be a source of restriction, as is now happening with titanium dioxide. A common chemical used as a pigment and thickener in a wide variety of applications for consumer use, including foodstuff, is about to receive a category 2 carcinogen classification, meaning heavy restrictions on its use in many of its current applications.

Competitive edge for European companies

One of the main original aims and visions of the comprehensive chemical legislation that is REACH is to ensure a high level of health and environmental protection. Another aim of the regulation has been to stimulate innovation and enhance the competitiveness of European brands on international markets. As chemical legislation is getting stricter all around the globe, REACH is indeed serving as an important example for other countries striving for increased chemical safety. This is one of the reasons why being REACH compliant is an asset all over the world; still today, REACH is the most advanced chemical legislation in the world.

Consumer image – a threat or a possibility?

An increasing amount of portals and sources for consumers on how to use chemicals safely and on how to find relevant safety information on chemicals have also emerged. Whilst a huge amount of scientifically-based information on chemicals and their safe use is now publicly available, what should never be underestimated is the opinion and views of the general public. Companies should therefore have an understanding of what the data gathered by them actually means and how it can be translated into facts and to transparent stakeholder communication.

Registration in the future

Now that all the three major deadlines for the REACH registration of chemicals in different tonnage bands have passed, the registration of future substances will require more planning in advance; as of now substances will need to be registered before manufactured or imported into the EU in amounts above 1 tonne per year. Make sure to make use of all the relevant exemptions to registration requirements. For R&D substances, for example, a PPORD notification will give your company a 5-year period of reflection before deciding on whether to continue with the substance or not. For substances produced in circular economy processes, further exemptions also apply.

 

For more of the concrete results that REACH keeps delivering, see the press release of the European Commission on the matter: http://europa.eu/rapid/press-release_IP-18-1362_en.htm

 

Leea Ojala, Senior consultant

20.6.2018, Helsinki

 

In case you have any questions about your obligations under the REACH Regulation or are interested in a REACH Declaration of Compliance or a screening of substance restrictions on your chemicals, contact Ecobio’s experts at: info@ecobio.fi or tel. +358 20 756 9450.

How to REACH the registration deadline by May 31st?

The REACH registration deadline is getting closer. Only a few weeks to go! ECHA has already received close to 22 000 registration dossiers. The most registrations have been filed from Germany, the United Kingdom and France. Here are a few tips for you regarding the approaching deadline:

Are you the lead registrant in a joint registration?

  • You should create a joint submission in REACH-IT by 9th May at the latest.
  • Continuously communicate your progress to the other members of the SIEF. They will have to meet the registration deadline and will want to know when they will be able to submit their company specific dossier.
  • Make sure that you have a transparent break-down of the costs for your Letter of Access (LoA) available in case the other SIEF members want to see it.

Are you a member in a joint registration?

  • You should submit your company specific dossier by the registration deadline.
  • Make sure that you initiate the process for purchasing the LoA early enough. Typically, you will receive a token for the LoA after all the transactions have been made.
  • Know what you pay for! Make sure you know what is included in your SIEF agreement (i.e. is the CSR part of the joint submission or not).

Are you a downstream user?

  • Ask your supplier for a REACH compliance declaration.
  • Make sure that all the substances you purchase have a proper registration number after the deadline.
  • A pre-registration number is not a proper registration number. All the registration numbers are recorded in ECHA’s substance information database. You can find them in the substance specific dossiers.
  • Know your obligations as a downstream user. Even though you don’t have to register, REACH still applies to you.

 

Contact Ecobio’s experts with any questions related to chemical legislation and the REACH Regulation. We are always happy to help.

For advice or for more information, you can contact us at info@ecobio.fi or tel. +358 20 756 9450.

Ecobio Manager – Regulation Tracking and Chemical Management Service

REACH 2018 Stakeholder’s Day – one week to go!

The European Chemicals Agency (ECHA) is organizing the REACH 2018 Stakeholders’ Day next week from 29 to 31 January in Helsinki. The conference offers hands-on training on different tools, such as Chesar, REACH-IT and IUCLID Cloud. In addition, the conference provides news and advice on the main issues companies are facing. The programme for the REACH 2018 Stakeholder’s Day:

  • Monday 29 January: hands-on training on Chesar, the chemical safety assessment and reporting tool
  • Tuesday 30 January: hand-on training on REACH-IT and IUCLID Cloud
  • Wednesday 31 January: conference

The most important theme of the conference is the 2018 REACH registration deadline, which is only in four months time. The conference presentations provide important advice on the registration, e.g. last-minute tips, how to get all of the data together and how to share costs. The conference is concluded with a panel discussion on what happens after the REACH 2018 deadline.

You can follow the conference live via web-streaming on 31 January and send questions online. More information and the full programme: https://echa.europa.eu/fi/-/reach-2018-stakeholders-day

Ecobio’s experts will be participating in the REACH Stakeholders’ Day. We are always happy to help with questions related to chemical legislation and the REACH Regulation. For advice or for more information, you can contact us at info@ecobio.fi or tel. +358 20 756 9450.

Ecobio Manager – Regulation Tracking and Chemical Management Service

New substances added to the Candidate List of substances of very high concern (SVHC)

January 18, 2018

The Member State Committee, MCS has identified 7 new substances as substances of very high concern and the substances have been added to the candidate list for authorization. The inclusion on the candidate list imposes immediate obligations for suppliers of the substance. An SVHC substance might also later end up on the list of authorized substances under the REACH Regulation (Annex XIV).

The following substances have been added to the candidate list:

  • Chrysene (CAS 218-01-9): Carcinogenic and persistent, bioaccumulative and toxic (PBT)
  • Benz[a]anthracene (CAS 56-55-3): Carcinogenic and persistent, bioaccumulative and toxic (PBT)
  • Cadmium nitrate (CAS 10325-94-7): Carcinogenic, mutagenic and specific target organ toxicity after repeated exposure
  • Cadmium hydroxide (CAS 21041-95-2): Carcinogenic, mutagenic and specific target organ toxicity after repeated exposure
  • Cadmium carbonate (CAS 513-78-0): Carcinogenic, mutagenic and specific target organ toxicity after repeated exposure
  • 1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”TM) [covering any of its individual anti- and syn-isomers or any combination thereof] (no CAS number): very persistent and very bioaccumulative (vPvB)
  • Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1% w/w 4-heptylphenol, branched and linear] (no CAS number): Endocrine disrupting properties

The properties of bisphenol A have been updated

Bisphenol A (BPA) has already previously been added to the candidate list due to its endocrine disrupting and reprotoxic properties. The entry has been updated to reflect an additional reason for inclusion due to its adverse effects to the environment.

ECHA’s newsletter: Seven new substances added to the Candidate List, entry for bisphenol-A updated

Four new substances in February

Additionally, four new intentions for identification as a substance of very high concern have been received for:

  • octamethylcyclotetrasiloxane (D4) CAS 556-67-2);
  • decamethylcyclopentasiloxane (D5) (CAS 541-02-6);
  • dodecamethylcyclohexasiloxane (D6) (CAS 540-97-6);
  • benzo[ghi]perylene (CAS 191-24-2).

The expected date of submission is 7.2.2018.

ECHA – Current SVHC intentions

Ecobio’s experts are always happy to help with questions related to chemical legislation and the REACH Regulation. For advice or for more information, you can contact us at info@ecobio.fi or tel. +358 20 756 9450.

Ecobio Manager – Regulation Tracking and Chemical Management Service

 

 

ECHA’s 10th Anniversary: Hurry Up with REACH Registrations

The European Chemicals Agency, ECHA, held their 12th Stakeholders’ Day in Helsinki, Finland, on the 5th of April 2017. Hundreds of chemical and product stewardship experts from around Europe attended the event. Ecobio enjoyed its position once again as a next door neighbour to ECHA.

At the Stakeholders’ Day, the ECHA representatives strongly encouraged all companies to hurry up with their REACH Registrations, as the registration deadline of the 31st of May 2018 is approaching soon for substances manufactured in or imported into the EU.

The following summarizes some of the main aspects presented by ECHA at the Stakeholders’ Day:

REACH 2018 – Challenges for registrants

  • Forming an unambiguous Substance Identity Profile and a boundary composition for other SIEF members takes time and effort
  • Joint registrations: challenges with poor-quality data, unfairness in cost sharing, issues on confirming substance sameness within a SIEF
  • Some substances still without a lead registrant or any registrant at all – what to do?
  • Diverging hazard classifications between different manufacturers create confusion and uncertainty
  • Getting information from customers and non-EU suppliers is tricky and time-consuming
  • Using alternative methods to animal testing still difficult
  • Test laboratories already fully-booked for toxicological and ecotoxicological tests

Good advice to registrants

  • Get going now: creating a high-quality dossier with all the relevant information requirements fulfilled takes a lot of time.
  • Small and medium-sized enterprises can perform REACH registrations by themselves. However, they should consider outside help, as the REACH Registrations require a lot of expertise from different fields of science, e.g. chemistry, toxicology and ecotoxicology.
  • Get wise – use the tools supported by ECHA to create the dossier: CHESAR, IUCLID and REACH-IT.
  • Use ready use maps created by industry associations where available – they help you in downstream communication and in identifying relevant downstream uses for your substance.
  • Demand good-quality information, fairness and transparency within a SIEF.
  • Communicate: up – and then down – the supply chain and within SIEFs.
  • Invest in good-quality data – it´s your business card.

After the 2018 registration deadline

  • Registration dossiers will be screened and evaluated by ECHA – companies should keep their dossiers up to date after the registration as well, instead of waiting for ECHA’s notification letter.
  • ECHA aims at tackling all substances of concern – these might include your substances. A good advice is to follow ECHA’s news and newsletters.
  • Information on all substances manufactured above 1 tonne per year in the EU will be freely available to all.

 

Ecobio’s experts are always happy to help with questions related to chemical legislation and the REACH Regulation. For advice or for more information, you can contact us at info@ecobio.fi or tel. 020 756 9450.

Ecobio Manager – Regulation Tracking and Chemical Management Service

REACH 2018

Chemical Management and the Regulation of REACH

Ecobio provides expert services related to the handling of chemical substances. REACH is the new European Union regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH came into force on the 1st June 2007. According to REACH, manufacturers or importers of chemical substances are required to register them with the central European Chemicals Agency (ECHA), located in Helsinki. The amount of substance data needed for the registration depends on the amount of substance manufactured or supplied. Registration is required for all substances manufactured or imported in quantities of 1 tonne per year or more. If you do not register, you will no longer be able to manufacture or supply them legally, i.e. no registration, no market!

It is the duty of the importer to register substances. Thus, companies from outside the EU cannot register substances themselves. However, companies exporting to the EU can appoint an Only Representative (a legal entity located within the EU) to handle the registration process. Should they do so, the registration burden will fall on the Only Representative and the importers will become downstream users. For manufacturers outside the EU, appointing an Only Representative is a way of ensuring that importers in the EU will not switch to chemical suppliers within the EU, just in order to escape the registration burden.

Ecobio provides companies expert guidance and consultation on how to fulfil REACH requirements. We help companies to recognize their roles and obligations and provide assistance on what measures to take, and when. Ecobio assists companies with the practical aspects of REACH, such as compiling chemical inventories, gathering data for the registration package, assisting with pre-registration (through REACH-IT), etc. Ecobio also provides strategic business consultation on the impact of REACH on your company’s business (cost factors, business opportunities, the impact of CMR substances on product image, substance availability in the future, etc.). Ecobio provides services for companies both within and outside the European Union.

Ecobio’s experts have master’s degrees in chemical and environmental engineering. Our strength lies in combining environmental and chemical expertise. Our experts have been trained to use the IUCLID 6 (International Uniform Chemicals Information Database) software application. IUCLID6 is an essential IT tool for industry to comply with REACH requirements. IUCLID 56is used, together with REACH-IT, for submitting registration data to the European Chemicals Agency.

Our REACH services include:

  • REACH impact assessment
  • strategic planning and recommendations: best practices and REACH responsibilities within the organization
  • chemical substance inventories and preparing for pre-registration
  • pre-registration (through REACH-IT)
  • managing chemical substance data and entering of data (through IUCLID 6)
  • third party representative services
  • information in the supply chain (handling inquiries, safety data sheets)
  • preparation and submissions of registration dossiers
  • assistance in obtaining of special services(such as toxicity and eco-toxicity testing services)
  • REACH training and workshops
  • REACH for executive managers (costs, cost savers, business opportunities).