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18 new substances of very high concern recommended to be added to the REACH Authorisation List

cheimcals of very high concern

ECHA (European Chemicals Agency) has recommended 18 new substances of very high concern (SVHCs) to be added to the REACH Authorisation list, from the Candidate list. The majority of the substances (13) are toxic to reproduction. The other substances includes two respiratory sensitisers, a carcinogen, an endocrine disruptor and a very persistent and very bioaccumulative (vPvB) substance.

One of the recommended substances to be added on the list is Bisphenol A or BPA (4,4′-isopropylidenediphenol) which is a commonly used chemical in the synthesis of plastics. BPA-based plastics are clear and though and used in many consumer products such as water bottles, sports equipment and CD’s.

The substances have been prioritized from the Candidate List because of their intrinsic properties, high volume and widespread uses, which may pose threats to human health or the environment.

The final decision regarding the inclusion of the substances in the list and the dates by which companies will need to apply for authorisation to ECHA will be taken by the European Commission in collaboration with the Member States and the European Parliament.

(ECHA 1.10.2019)

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4 new substances added to the SVHCs Candidate List

high risk substances and chemicals

ECHA (European Chemicals Agency) has added four new substances to the Candidate List of substances of very high concern (SVHCs) for authorisation. The substances are added due to their toxicity to reproduction, endocrine disruption and a combination of other properties of concern. The list now contains 201 substances.

The Candidate List contains substances that may have serious effects on human health or the environment. Substances added to the list are candidates for eventual inclusion in the Authorisation List. Once they are on the Authorisation List, companies will need to apply for permission to continue using the substance.

The substances added are listed in the table below:

# Substance name EC number CAS number Reason for inclusion Examples of use(s)
1 2-methoxyethyl acetate 203-772-9 110-49-6 Toxic for reproduction (Article 57 (c)) Not registered under REACH.
2 Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) Endocrine disrupting properties (Article 57(f) – environment) Primarily used as an antioxidant to stabilise polymers.
3 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) Equivalent level of concern having probable serious effects to the environment (Article 57(f) – environment) and human health (Article 57(f) – human health) Processing aid in the production of fluorinated polymers.
4 4-tert-butylphenol 202-679-0 98-54-4 Endocrine disrupting properties (Article 57(f) – environment) Used in coating products, polymers, adhesives, sealants and for the synthesis of other substances.

Table source: https://echa.europa.eu/-/four-new-substances-added-to-the-candidate-list 

Companies may have legal obligations resulting already from the inclusion of the substance in the Candidate List. Importers and producers of articles containing the substance have six months starting from today (16 July 2019) to notify ECHA.

If you have any questions regarding the changes or need help related to the handling of chemical substances in the European Union do not hesitate to contact us!

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Contact details:

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News original source: ECHA

Algae – Promising Feedstock for Biofuels

The production of algae was one of the most interesting subjects in The ABLCGlobal Conference for bioeconomy hold in November, 2018, in San Francisco.

 

Algae-based biofuels and bioproducts offer great promise in contributing the U.S. Department of Energy. In recent years, the algae biofuels research, development and demonstration has achieved technological advancements that can bring about transformational changes, including the ability to predict, breed, and select the best-performing strains; the ability to monitor and control system inputs in a dynamic and integrated fashion; the ability to harvest algae at high throughputs; and the ability to extract and convert more algal biomass components into fuels.

According to Neste, the Finnish oil company, algae oil is a promising raw material for renewable diesel. The years of development is now starting to bear fruit globally as pilot testing facilities and commercial plans. Algae’s yield per hectare can be many times the yield of traditional vegetable oils. In addition to water, algae needs sunlight, carbon dioxide and nutrients to grow. Many species of algae live in sea water, which means that they can be grown in saline water. Some projects even use wastewater. A special advantage in the cultivation of algae is the fact that they can be grown in areas that cannot be used for agriculture. Neste supports the commercial scale production by signing conditional off-take agreements with algae companies. Such agreements have been signed with American companies Cellana and RAE. The production volumes may increase in the years to come, and algae oil may become an important raw material of Neste’s renewable diesel.

 

Sources

USDE, Algal Biofuels, http://energy.gov/eere/bioenergy/downloads/2016-national-algal-biofuels-technology-review

Neste, https://www.neste.com/algae-oil-promising-raw-material-renewable-diesel-%E2%80%93-neste-oil-ensures-its-supply-conditional

ilmastovaikutuksia

ECHA’s Biocides Stakeholder Day coming up

The European Chemicals Agency ECHA will be hosting the Biocides Day 2018 on the 24th and 25th of October in Helsinki, Finland. The stakeholder day will give insight into the latest developments in biocides at the EU level.

In the EU, the Biocidal Products Regulation (BPR) regulates the placing on the market and use of biocidal products. As a principle, biocidal active substances must be approved for use at Union level, and all biocidal products require an authorisation before they can be placed on the market. Product authorisations take place either at Member State level or as a Union authorization.

As active substances are increasingly being approved for use, the need for the authorization of the biocidal active products containing such active substances are becoming imminent. For example, the deadline for the product authorization application of sodium hypochlorite is already 1.1.2019.

The Biocides Day by ECHA will deal with e.g.
• tips for a successful Union authorisation
• best practices for a product family authorisation
• the impact of Brexit and
• the impact of endocrine disruptor criteria

You can join the day through ECHA’s webpages: https://echa.europa.eu/fi/-/biocides-day

Ecobio’s expert will also be present; you are more than welcome to ask us anything relating to chemical or biocides legislation! Contact us at info@ecobio.fi.

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.

Ecobio chemicals quiz – test your knowledge of CLP hazard pictograms

Ecobio has published a chemicals quiz for testing knowledge of chemicals. The quiz is intended for those using or working with chemicals. Are you already familiar with the new CLP hazard pictograms for chemicals? Test your knowledge with the quiz. Show off your expertise and get a certificate for your office wall.

https://www.ecobiomanager.com/chemicalstest

Hazard pictograms for chemicals have changed after the expiry of the final transition period of the EU’s CLP Regulation. Old orange and black pictograms have been replaced with new, EU wide red-white-black hazard pictograms. The signs are found for example in workplaces, on chemical containers, and on products sold in shops. Exposure to chemicals can be a major health hazard. Hazard pictograms are used to ensure the safe use of products.

Ecobio helps companies fulfil chemical requirements. Also learn about our Ecobio Manager service, which helps you keep up with regulations and requirements. www.ecobiomanager.com

Additional information:
Pia Välitalo, Project Manager, Ecobio, tel. +358 20 756 9450, pia.valitalo@ecobio.fi

 

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).