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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!

Our Ecobio Manager service helps you keep up with regulations and requirements.

Contact details:

sales@ecobiomanager.com

info@ecobio.fi


News original source: ECHA

adaptation

The 12. adaptation to technical progress of the CLP

Change (EU) 2019/521

The 12. adaptation to technical progress (ATP) of the CLP Regulation adopts the sixth and seventh revised editions of the GHS. The sixth and seventh revised editions of the GHS result from changes adopted in 2014 and 2016 respectively by the United Nations Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals. These changes introduce a new hazard class for desensitised explosives and a new hazard category, pyrophoric gases, within the hazard class flammable gases.

Other changes include adaptations to: the criteria for substances and mixtures which in contact with water emit flammable gases, the generic cut-off values; the general provisions to classify aerosol forms of mixtures; and the detail of the definitions and classification criteria as appropriate for the hazard classes explosives, flammable gases, flammable liquids, flammable solids, acute toxicity, skin corrosion/irritation, serious eye damage/eye irritation, respiratory and skin sensitisation, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific target organ toxicity and aspiration hazard. In addition, amendments are introduced to some hazard and precautionary statements.

To ensure that suppliers of substances and mixtures have time to adapt to the new classification, labelling and packaging provisions, this Regulation will be applied starting from the 17th of October 2020. However, suppliers can apply the new provisions on a voluntary basis already before the date of application.

Ecobio will gladly answer any questions regarding chemical legislation or chemical management. Contact our experts at: info@ecobio.fi or tel. +358 20 756 9450.

chemicals kemikaalit testing

New Proposition 65 Fact Sheet on Styrene

California Environmental Protection Agency has published a new fact sheet on styrene.

Styrene is a widely used chemical that can be found in several different products. It’s an industrial chemical used to produce several different products including synthetic rubbers, latex paints and coatings, and polystyrene plastics and resins, but styrene is also on the Proposition 65 list of chemicals that cause cancer.

Styrene is released into indoor air from some paints and building materials, such as certain types of insulation, insulated panels, and rubber flooring. It is released into indoor air during the operation of some 3D printers that use filaments containing acrylonitrile butadiene styrene (ABS) or high-impact polystyrene (HIPS). It can also be released by some photocopiers and laser printers that use toners containing styrene copolymers. It is released into the air from some industrial facilities including plastics and fiberglass manufacturers, and waste disposal sites. Small amounts of the chemical can be transferred to some food from polystyrene-based food-contact items such as drinking cups, plates, and other containers. Styrene is found in tobacco smoke. During pregnancy, the chemical can pass from mother to baby. Additional information.

 

Ecobio Manager provides an effective platform for industrial substance management. Please ask for further information about our service www.ecobiomanager.com, or a presentation: sanna.perkio@ecobiomanager.com.

We help you balance business and nature: www.ecobio.fi.

Ecobio

Ecobio 30 challenges you to take climate action

This Spring Ecobio celebrates its 30th anniversary as a corporate sustainability service provider.

Inspired by this significant event, we decided to deepen our understanding of the necessary climate actions needed at the individual level. Therefore, we are taking part in the global climate action project, EcoChallenge of Project Drawdown. As the only Finnish participant, we challenge you to join our team now: Ecobio 30 years for sustainability.

Drawdown EcoChallenge is a 21-day engagement program focused on carbon reduction. The challenge takes place April 3-24.

Participants track and share their progress online in a robust platform and earn points for taking action. The combination of collective action, camaraderie, and friendly competition make change a little easier — and a lot more fun. EcoChallenge provides tools and inspiration to turn intention into action and gives participants a fun and social way to think about and act on proven solutions to reverse global warming. Over eighty actions within seven challenge categories provide participants with diverse options to reduce carbon usage.

EcoChallenge is free and open to the public. Participants can join an existing team, create a new one, or join the Community team.

“EcoChallenge is an incredible tool for climate actions from schools to corporations all over the world. It empowers people to learn more.”

– Chad Frischmann, Project Drawdown.

Check out Frischmann’s TED talk “100 solutions to reverse global warming” and join the action!

Materiaalitehokkuuden

Summary of the new U.S. Climate Report

The impacts of global climate change have already been felt in the United States. At the end of 2018, the U.S. Government published the national climate report, which dealt with impacts, risks, and adaptation of climate change in the United States. The U.S. Climate Report detailed the measurable implications of global-warming trends upon not only the environment itself but on human health and the American economy. The summary of the findings are presented in the following.

The impacts of climate change are diverse

“Climate change creates new risks and exacerbates existing vulnerabilities in communities across the United States, presenting growing challenges to human health and safety, quality of life, and the rate of economic growth.

Without substantial and sustained global mitigation and regional adaption efforts, climate change is expected to cause growing losses to American infrastructure and property and impede the rate of economic growth over the country.

Climate change affects the natural, built, and social systems we rely on individuals and through their connections to one another. These interconnected systems are increasingly vulnerable to cascading impacts that are often difficult to predict, threatening essential services within and beyond the Nation’s borders.

Communities, governments, and businesses are working to reduce risks from and cost associated with climate change by taking action to lower greenhouse gas emissions and implement adaption strategies. While mitigation and adaptation efforts have expanded substantially in the last four years, they do not yet approach the scale considered necessary to avoid substantial damages to the economy, environment, and human health over the coming decades.

The quality and quantity of water available for use by people and ecosystems across the country are being affected by climate change, increasing risks and costs to agriculture, energy production, industry, recreation, and the environment.

Impacts from climate change on extreme weather and climate-related events, air quality, and the transmission of disease through insects and pests, food, and water increasingly threaten the health and well-being of the American people, particularly populations that are already vulnerable.

Climate change increasingly threatens Indigenous communities’ livelihoods, economies, health, and cultural identities by disrupting interconnected social, physical, and economic systems.”

Ecosystem services continue to be threatened

“Ecosystems and the benefits they provide to society are altered by climate change, and these impacts are projected to continue. Without substantial and sustained reductions in global greenhouse gas emissions, transformative effects on some ecosystems will occur; some coral reef and sea ice ecosystems are already experiencing such changes.

Rising temperature, extreme heat, drought, wildfire on range lands, and torrential downpours are expected to disrupt agricultural productivity in the United States increasingly. Expected increases in challenges to livestock health, the decline in crop yields and quality, and changes in extreme events in the United States and abroad threaten rural livelihoods, sustainable food security, and price stability.

U.S. aging and deteriorating infrastructure in further stressed by increases in heavy precipitation events, coastal flooding, heat, wildfires, and other extreme events, as well as changes to average precipitation and temperature. Without adaption, climate change will continue to degrade infrastructure performance over the rest of the century, with the potential for cascading impacts that threaten our economy, national security, essential services, and health and well-being.

The impacts of climate change increasingly threaten coastal communities and the ecosystems that support them. Without significant reductions in global greenhouse gas emissions and regional adaption measures, many coastal regions will be transformed by the latter part of the century, with impacts affecting other areas and sectors. Even in the future with lower greenhouse gas emissions, many communities are expected to suffer financial impacts as chronic high-tide flooding leads to higher costs and lower property values.

Outdoor recreation, tourist economies, and quality of life are reliant on benefits provided by our natural environment that will be degraded by the impacts of climate change in many ways.”

 

Source: U.S. Global Change Research Program, The Climate Report, The National Climate Assessment – impacts, risks, and adaptations in the United States, January 2019, Melville House Publishing

Additional information: https://www.globalchange.gov/

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

Plastics Roadmap – Towards a sustainable plastic economy

Reduce and Refuse, Recycle and Replace. The Plastics Roadmap for Finland was published 16th of October 2018 by the Ministry of the Environment, leading the way towards a new, sustainable plastic economy. The roadmap presents a set of key actions to find solutions to challenges caused by plastics.

The proposals for measures are:
  • Avoid littering and unnecessary consumption
  • Study the possibility to introduce a tax on plastics
  • Increase significantly the recovery of plastic waste
  • Improve the identification of plastics in buildings and sorting of plastic waste in construction sites
  • Promote the recycling and replacement of plastics in agriculture and horticulture
  • Introduce diverse recycling solutions for recovered plastics
  • Invest in a big way in alternative solutions and set up a New Plastics knowledge network
  • Raise the challenge of plastics high on the international agenda of Finland
  • Export expertise and solutions
  • Enhance research knowledge on negative health and environmental impacts of plastics and solutions to these

Plastics have lots of good properties and they are important to our economy. However, there are also significant problems relating to plastics. One of the pressing concerns is the amount of plastics ending up in the environment, in the seas and potentially in the food chains.

Plastic challenge is an opportunity for Finland and for Finnish companies. Around the world there is a growing need for safe, bio-based, recyclable, and 100% biodegradable packages. Finland has strong expertise in biomaterials and available raw materials that offer opportunities to find solutions for replacing plastics. Finland is ready to tackle the plastic challenge with good cooperation!

Ecobio is happy take part in tackling the Plastic challenge and to help companies towards a new, sustainable plastic economy. Contact our experts at: info@ecobio.fi or tel. +358 20 756 9450.

 

Read the whole article and more about the Plastics Roadmap for Finland: http://www.ym.fi/en-US/Latest_news/Press_releases/Reduce_and_Refuse_Recycle_and_Replace__P(48213)

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.

REACH Compliance?

Osoita vaatimustenmukaisuutesi sidosryhmille

Kemikaalien REACH-rekisteröintien viimeinen takaraja EU:ssa oli 31.5.2018. Takarajan umpeuduttua REACH-vaatimustenmukaisuustodistukset (Declaration of Compliance) ovat yleistyneet. Vaatimuksia vaatimustenmukaisuuden osoittamiselle tulee niin viranomaisilta, asiakkailta kuin muilta sidosryhmiltä. Vaatimustenmukaisuuden osoittaminen koskee aineiden valmistajien sekä maahantuojien lisäksi jatkokäyttäjiä, sillä esimerkiksi ainerajoitukset koskevat kaikkia toimitusketjun toimijoita.

Mikä on “REACH Declaration of Compliance”?

“REACH Declaration of Compliance” tai ”todistus REACH-vaatimustenmukaisuudesta” on asiakirja, jolla osoitetaan, että yritys tai yrityksen valmistamat tai maahantuomat tuotteet täyttävät REACH-asetuksen mukaiset velvoitteensa. Todistuksessa osoitetaan muun muassa rekisteröintivelvoitteet, olennaiset poikkeukset velvoitteista ja niiden hyödyntäminen sekä ainerajoituksien seuranta. Todistus voidaan suunnata erikseen viranomaisille tai asiakasviestintään, tai vastaavasti tehdä yksi versio, joka soveltuu kaikille.

Ainerajoitukset oleellinen osa vaatimustenmukaisuutta

Ennen vaatimustenmukaisuustodistuksen laatimista on hyvä tehdä selvitys yritystä koskevista ainerajoituksista. Ainerajoitusselvityksessä käydään läpi kaikki yrityksen toiminnassa tai tuotteen valmistuksessa käytettävät kemikaalit ja selvitetään, sisältyvätkö ne REACH-asetuksen alla erityistä huolta aiheuttavien aineiden listalle (SVHC-lista), rajoitettuihin aineisiin tai luvanvaraisiin aineisiin.  Valvova viranomainen voi myös vaatia tällaista selvitystä ainerajoituksista valvonnan tueksi.

Kiinnostaako todistus vaatimustenmukaisuudesta?

Ecobion asiantuntijat auttavat mielellään REACH-vaatimustenmukaisuuteen liittyvissä kysymyksissä. Laadimme vaatimustenmukaisuustodistuksia, jotka sisältävät ainerajoitusselvityksen. Ainerajoitusselvityksen yhteydessä toimitamme asiakkaalle ainerajoituksien seurantaan Excel-työkalun sekä raportin, jota voi hyödyntää esimerkiksi viranomaisasioinnissa. Vaatimustenmukaisuustodistuksia laadimme suomeksi, englanniksi ja ruotsiksi.

Ota yhteyttä kemikaalitiimiimme, me autamme:

Pia Välitalo, pia.valitalo@ecobio.fi, puh. 020 756 9453

Leea Ojala, leea.ojala@ecobio.fi, puh. 020 756 9455

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.