Author: Ecobio

The requirements of Safety Data Sheets (SDS) in the REACH regulation have been modified to comply with the rules of the GHS. The changes concern e.g. Requirements for the placement of UFI labels, labeling of nanoforms and endocrine disruptors and mixtures.

The SDS-requirements amended by the Commission

Annex II of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was amended by Commission Regulation (EU) 2020/878 of 18.6.2020. Annex II further restricts the requirements for the preparation of safety data sheets (SDS).

Earlier this year, the European Commission invited stakeholders to comment on the amendments to Annex II, which have now been published in the Official Journal of the European Union. Due to the changes, SDS suppliers, such as chemical manufacturers and mixers, need to make significant changes to their safety data sheets. SDSs are an important part of hazard communication, providing information on the safety of substances and mixtures in the supply chain from the manufacturer to downstream users.

The changes in SDS requirements

The amendment to REACH sets requirements for safety data sheets (SDS). These are amended to be in line with the rules set for SDSs in the 6th and 7th revisions of the GHS and CLP ((EU) 1272/2008). The change takes into account the labeling of nanoforms in the SDSs. Each relevant section of the SDS shall indicate if the section covers nanoforms, which different nanoforms are covered, and combine each nanoform with the relevant safety information. Instructions for affixing the UFI label to SDSs have also been specified. If necessary, the UFI identifier shall be entered in section 1.1 of the SDS. In addition, for substances with a harmonized classification, a specific concentration limit, an M-factor, and an estimate of acute toxicity, if available, must be provided in section 3 of the SDS.

Furthermore, the requirements for SDSs for endocrine disruptors and mixtures have been amended. Section 2.3 provides information on endocrine disrupting properties of the substance. The endocrine disrupting ingredient must be indicated in section 3 of the SDS if its concentration exceeds 0.1%. Information on endocrine disrupting properties that cause health or environmental effects is provided in the new sections 11.2 and 12.6 of the SDS.

The regulation will enter into force on 16 July 2020 and will apply from 1 January 2021. The transition period for the new requirements is two years. This means that old safety data sheets can still be submitted until 31 December 2022.

Need help with chemical management or updating safety data sheets?

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Text: Anne Kallioinen, Ecobio Oy

Picture: Shutterstock

Source: https://eur-lex.europa.eu/legal-content/FI/TXT/?uri=uriserv:OJ.L_.2020.203.01.0028.01.FIN&toc=OJ:L:2020:203:TOC

May 29, 2020

Minimize workplace safety risks during COVID-19

Are you aware of the risks caused by COVID-19 on your workplace? Does your company have a waterproof plan to manage them?

Our shared challenge is to make sure business works as usual, even in uncertain times. A safe workplace is not a matter of course. Many of us work in at least somewhat vulnerable working conditions. Most remote workers who are now returning to work can be exposed to the coronavirus (COVID-19) either on their way to, or at work. The global pandemic naturally raises a lot of questions in the work community that require clear answers and safe solutions from the leaders. By identifying and systematically managing the risks posed by a pandemic, you can build trust in the work community and ensure that your business works even in times of uncertainty.

How do I secure business continuity?

In order to ensure the profitability of your business it is important to identify what your business cannot afford to lose. Identifying and conserving critical resources and operations is necessary for a company to be able to avoid fatal losses during a crisis. Critical resources can be divided into six groups; employees, facilities, key functions, warehouses or special equipment, IT resources and key third parties such as investors, subcontractors, and suppliers. Identifying and protecting these critical resources will help you reduce your risks.

Developing a crisis strategy and strengthening operational reliability are an integral part of business continuity in uncertain conditions. The Ecobio Manager SaaS-service provides an easy-to-use and hands-on way to maintain reliability with the help of risk management and compliance tools. The tool can be customized to suit the needs and size of your business.

Identifying risks can help you understand how vulnerable your business is to the dangers of an epidemic. In particular small businesses have limited resources, which makes using them effectively essential.

Secure the safety of your workplace during COVID-19 with the help of the Ecobio Manager Risk Management tool

At Ecobio, we want to help companies worldwide to maintain profitable, responsible, and safe businesses where the employee’s health is taking care of. We, therefore, offer companies a free trial of the Ecobio Manager COVID-19 Risk Management tool for three months.

The Ecobio Manager SaaS-service offers a solution that utilizes industrial procedures to manage risks caused by the coronavirus at the workplace, but also other risks such as environmental-, occupational health and safety-, fire- and rescue risks. The service includes a tool for identifying bacterial and viral hazards and risk assessment, as well as a management plan. In addition, you can keep up-to-date with changes in COVID-19 legislation and regulatory guidelines. You can conveniently save your organization’s instructions or other essential guidelines to the service. You can also assess the compliance of your operations with laws, regulatory guidelines, and compliance with your own guidelines in the EU and US. The service helps your business stay up to date in a changing situation.

The COVID-19 Risk Management service package includes the following services:

Hazard identification, risk assessment and management of COVID-19 hazards as a cloud service
COVID-19 risk management training

If you want a comprehensive service for COVID-19 obligations management, you can extend risk management to include the following services:

Up-to-date regulation of COVID-19
Up-to-date authority guidance of COVID-19
Save and manage your own instructions
Compliance assessment tool

Send your company information & subscribe to the service: sales@ecobiomanager.com

Read more about Ecobio Manager: www.ecobiomanager.com

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April 21, 2020

COVID-19 impacts on Climate Change

How are Climate change and COVID-19 linked? Can the measures taken to battle COVID-19 have a positive effect on the climate?

On a certain level, parallels can be drawn between the COVID-19 pandemic and other contemporary crises that we are facing today, such as climate change. These kind of global crises all require a global-to-local response, long-term thinking, new research and innovations and a political will to make fundamental changes. (Weforum, Climate Foresight)

The COVID-19 virus that started in 2019 in a small wet market in Wuhan, China, has become a global pandemic over the period of a few months and has already had a seemingly big effect on our daily lives.

A topic that has been discussed over the internet and in numerous articles in the media concerns how governments are able to respond so fast to COVID-19, even with the risk of a collapsing economy, while the battle against climate change seems to be too hard and sensitive to tackle. Keeping in mind that the expected deaths per year due to climate change are estimated to be over 10 times higher than those from COVID-19, this is an important question. The answer remains deeper and more versatile than this, but some of the reasons are simple: COVID-19 is happening right now, it is visible and fast moving and it has an immediate and direct effect on everyone and anyone. The measures are also more straightforward. Governments have been given priority lists of compelling their citizens to wash more, stop touching, reduce travel and go into some degree of isolation. In contrast, the variety of solutions to fight climate change are perplexingly complex. And the solutions affect nearly all aspects of modern life. (Ecowatch)

COVID-19 effects on the climate

There has been numerous speculations about whether COVID-19 could stop the rapid increase of temperatures. Across continents, flights are being cancelled, factories closed down, those whose work isn’t critical for the society are holed up at home and as a consequence pollution and greenhouse gas emissions have fallen as countries try to contain the spread.

The New York Times published an article discussing NASA’s satellite imagery showing remarkable reductions in pollutions in China and Italy when the outbreak first started. Furthermore, The Guardian stated that the pandemic could lead to a significant fall in global CO2 emissions.

In China, emissions fell 25% at the start of the year and coal use fell by 40% at China’s six largest power plants since the last quarter of 2019. Similarly, levels of pollution in New York have reduced by nearly 50% compared with this time last year. This is however not the first time an epidemic or global crisis has led to lower emissions. During the financial crash in 2008 the global emissions dropped significantly for a year. (BBC) Global CO2 emissions from fossil fuel combustion and cement production decreased by 1.4 percent, only to rise by 5.9 percent in 2010. (Human Rights Watch)

The flip side of the coin

Some experts are concerned, that the effects of COVID-19 are only going to be short termed. One of the side effects of the virus include delayed or cancelled events and projects. Climate meetings and summits are no exception. Among these is the UN’s annual climate summit 2020, where 196 countries were expected to introduce revamped plans to meet the emission reduction goals, which was postponed to 2021. Furthermore, countries all over the world are postponing green investments and instead directing the money to fight COVID-19. Like so, companies struggling to keep their business running are not likely to make long term green investments in the near future. To act against climate change has never been more urgent. However, the inability to collect world leaders and to direct finances towards green investments might be a hinder to do so.

In the U.S., Environmental Protection Agency announced a rollback on car emissions rules. The rules were a central piece of the country´s efforts to reduce greenhouse gas emissions. Furthermore, it announced that it will not penalize companies that fail to comply with federal monitoring or environmental reporting requirements. Similarly, China has extended deadlines for companies to meet environmental standards and Brazil has announced it is taking back enforcement duties for protecting the Amazon from accelerating deforestation, which could lead to the release of massive amounts of greenhouse gases. (BBC, Human Rights Watch, Climate Foresight)

What is certain, is that “There is a strong link between economic activity and global carbon dioxide emissions, due to the dominance of fossil fuel sources of energy.” This means we might be in for an positive surprise due to the coronavirus pandemic: a slowdown of carbon dioxide emissions due to reduced energy consumption. (Centre for International Climate Research)

In summary

We’ve seen that governments can act, and people can change their behavior, in a very short amount of time.
COVID-19 can have a positive effect on climate change. If this leads to a long-term shift in behavior and a change in our mindset and priorities.
The pandemic may lead to a deeper understanding of the ties that bind us globally.
Well-resourced healthcare systems are essential to protect us from global crises.
Economic activities and global emission rates are strongly linked.

Need help with managing the impacts that COVID-19 or climate change has on your workplace? Our Environmental and Chemical experts are here to help!

Contact us:

info@ecobio.fi

+358 (0) 207 569 450

You might also be interested in:

Insights into Covid-19 future effects on energy consumption and cleantech: Future Proof blog by Futures Platform

Text: Caisa Lindblom, Ecobio Oy, caisa.lindblom@ecobio.fi

Picture: Shutterstock

March 17, 2020

Important Brexit deadlines for importers and users of chemicals

The United Kingdom (UK) has formally left the European Union (EU) on the 31 of January 2020. However, the realisation of Brexit is still to be defined by key decisions of the EU and UK, leaving minimal time for any involved party to prepare. Unless otherwise decided, British chemicals no longer remain in the common EU market. This would mean that UK companies’ EU REACH registrations would be void at the end of the transition period, and companies purchasing chemicals from the UK suppliers would be EU REACH importers, needing registrations according to the rules of EU REACH.

Chemical Watch summarises the key dates of Brexit as follows:

31.1.2020: UK leaves EU – the transition period begins
Early 2020: European Commission to publish its draft negotiating objectives for approval
30.6.2020: Deadline for extending the transition period
31.12.2020: End of the transition period (unless decided to be extended)
2022: England’s chemicals strategy to be published

What does this mean for companies?

EU-REACH registrations: current registrations will terminate at the end of the transition period. UK companies having registrations need to transfer their registrations to an EU-27/EEA based company or an Only Representative by the end of the transition period. An authorisation granted to UK based companies will also cease at the end of the transition period. Transfer of authorisations to an EU-27/EEA based Only Representative is recommended by ECHA for securing the supply chain.

UK-REACH registrants will need to provide basic information within 120 days of the country leaving the EU. A transition of 2 years is planned for providing technical information for tonnage bands under UK-REACH. There are still important details to be solved.

There are Statutory Instruments (SI’s) under preparation for creating national UK laws for REACH and CLP Regulations, Prior Informed Consent (PIC) Regulation, Biocides Regulation, Cosmetics, Detergents, Restrictions of hazardous substances in electrical and electronic equipment (RoHS).

The UK Environment Bill was published in October 2019, giving the environment minister powers to amend the UK REACH and its enforcement regulations. The Chemicals Strategy is under preparation. Its expected due date is 2022, well after the transition period (unless decided to be extended).

In January 2021, the UK will start a completely new relationship with EU – either with an agreed and ratified trade deal, or without it.

Are you an importer or user of chemicals within the EU? Are you concerned about how Brexit will affect your business? Our chemical experts are here to help you! Contact us

Helena Niemelä

Senior Consultant, Ecobio Oy

helena.niemela@ecobio.f

Reference: Global Outlook 2020: How will the Brexit endgame shape up? Chemical Watch 28.1.2020.

January 22, 2020

Four new substances added to the SVHC Candidate List

ECHA has added four new substances to the Candidate List of substances of very high concern (SVHC) due to their toxicity to reproduction and a combination of other properties of concern. This means that the Candidate List now includes 205 substances. Any supplier of mixtures or articles containing a Candidate List substance above a concentration of 0.1 % (weight by weight) has communication obligations towards customers down the supply chain and to consumers. The supply chain communication obligation is important for the whole supply chains of mixtures and articles in the EU.

The added substances are: Diisohexyl phthalate, 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone (used in polymer production), 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (used in polymer production) and Perfluorobutane sulfonic acid (PFBS) including its salts.

The first three substances are added due to their toxicity to reproduction. The fourth substance, PFBS, belongs to the group of per- and polyfluorinated substances, and is added due to its probable serious effects to human health and the environment. The first phthalate is not registered, the second and third substances are used in polymer production. PFBS is used as a catalyst/ additive/reactant in polymer manufacture and in chemical synthesis. It is also used as a flame retardant in polycarbonate (for electronic equipment).

Companies that are importing, producing, selling or using substances, their mixtures or articles (components, materials) containing them should keep an eye on the substances added to the SVHC Candidate List. Substances are regularly being added here. It is recommended for companies to start looking for substitutes for the added substances already now.

Need help with chemical management?

Our experienced chemical consultants will assist you in meeting your chemical requirements. Furthermore, our Ecobio Manager SaaS-service will help you manage your chemicals and ensure compliance with global regulations. Interested? Contact us today!

Contact: info@ecobio.fi

Source: https://echa.europa.eu/fi/-/four-new-substances-added-to-candidate-list

January 13, 2020

The quality of safety data sheets does matter

Creating and submitting a safety data sheet, basically a digital document, has technically never been as easy as today. But how about the quality?

Receivers and users of chemicals have “forever” been complaining that many safety data sheets do not meet their expectations. A similar message was heard just before Christmas from the European authorities’ enforcement project on classification and labeling of mixtures in the EU market. With all REACH data and IT tools available, a competent and responsible actor should already be able to prepare good quality documents. Nevertheless, safety data sheets do have many kinds of users, with conflicting expectations and increasingly more frequent updating requirements. Maintaining sheets up to date is therefore not an easy task. But as the complaints of low quality seem to persist, there might be reasons behind to explore.

If chemicals’ hazards are not right, how can any receiver, user or decision maker get reliable information from safety data sheets?

To me as a regulatory professional, the fundamental core is whether chemicals’ hazards are correctly identified, labelled and communicated in the supply chain. This refers indeed to the inspected sections 2, 3, 9, 11, 12 and 16 of safety data sheets. If these are not right, how can any receiver, user or decision maker get reliable information about the chemical hazards and risks of their products and materials?
For improving the availability of reliable information on chemical hazards, I’d pay attention to few important practicalities having recently come across.

The key role of the EU importer

The first issue is a reminder of the key role of the EU importer. In global supply chains the EU importers should be the ones implementing the world’s most ambitious regulations to their chemicals. Do EU importers get reliable information for identifying the most hazardous substances in the EU, starting typically from 0.1 % concentrations? A supplier safety data sheet created in the country of origin is not enough. EU regulations are not globally valid.

Not all chemicals on the EU market need to be comprehensively tested in low volumes

Secondly, not all chemicals on the EU market need to be comprehensively tested in low volumes. Hazard data, especially on chronic properties can still be lacking “legally”. The main regulation CLP, detailing classification and labeling rules for marketed products (mixtures), does not require additional testing. REACH should take care of that in the background, generating hazard data for component substances. However, REACH testing requirement starts from volumes of one tonne per substance, extending to chronic endpoints from 100 tonnes on. Eventually, classification of the most hazardous substances (carcinogens, mutagens, reproductive toxicants, respiratory sensitizers; persistent, bioaccumulative and environmentally toxic or mobile substances; and especially endocrine disruptors) are ultimately harmonized by authorities’ assessments. Classification process for harmonized chronic hazards may take many years.

How to find reliable information of new alternatives not yet properly tested?

If someone is looking for new alternatives, for example to substitute an existing hazardous chemical, finding new reliable information can be challenging. If the quality of suppliers’ safety data sheets is low, or the most hazardous properties are not yet allowed to be tested, how to make well informed decisions on the best alternatives for future products?

Benefits of quality

Ultimately, poor quality safety data sheets may result in biased business decisions and investments. They may cause operational delays and surprises regarding usability of the raw material, product, application or access to market. They add operational costs and workload for the whole supply chain, and the big picture might be lost. From the occupational health and safety point of view, missing information on hazards and risks hinder their proper identification, management and communication.

Ability to provide good quality safety data sheets, correct labels and ultimately safer products in a timely manner tells a lot about the quality and responsibility of the supplier. If generated early enough, high quality information will enable early identification and investments on sustainable products and technologies and prevent wasting resources on hazardous sunset chemicals. Forerunners will benefit from their strategic investments on good quality information, enabling fact-based decisions.

In the real life, the trickiest question nevertheless remains: which quality is good enough? Good quality is always fit for purpose for the users, and the result of continuous improvement.

Contact:

Helena Niemelä

Leading consultant

helena.niemela@ecobio.fi

This article reflects the views of the author, with 15 years’ experience on REACH implementation and submissions of nearly 100 REACH registrations, providing data content to numerous safety data sheets. Ecobio can help our customers also in improving the quality of their key safety data sheets. Read more about our services

January 2, 2020

How to measure environmental performance of port operations?

Did you know that an environmental product declaration (EPD) can be prepared for port operation services? The EPD International (www.environdec.com), a Swedish-based international programme operator, has defined the product category rules for port operation services already in 2018. The first EPD based on these rules has been published by the port of Bilbao. See the EPD for Port of Bilbao here.

What is an EPD?

The EPD is used for presenting the potential environmental impacts of products or services based on a life cycle assessment. In order to produce comparable declarations, product category rules have been defined for some products, product groups or services. These rules help you produce more comparable EPDs. This way the environmental impacts of different products can be compared.

Furthermore, the EPD helps you identify the greatest environmental impacts. Once it is known what causes the environmental impacts, it is more efficient to address the actions for reducing the environmental impacts. The EPD is thus one way of showing the level of environmental management.

The EPD of Bilbao Port operation services has attracted the interest among its visitors, media and other ports. Ecobio encourages other ports to evaluate the environmental impacts of their operations.

Ecobio’s environmental services

Ecobio’s environmental experts produce EPDs for ports, construction products and other necessary activities. The environmental performance of port operations can also be demonstrated by other means than by an EPD. For example by carbon footprint calculation and compensation, meeting requirements of standards or with the help of environmental strategies. We will help you find the right solutions. Contact us!

Contact details:

info@ecobio.fi

December 19, 2019

Merry Christmas & Long live the Baltic Sea!

Merry Christmas!

Dear partner, we want to thank you for the past year and wish you a peaceful Christmas season and a successful upcoming year of 2020!

This year we have chosen to donate our Christmas gift to the Baltic Sea Action Group (BSAG), which is actively working to improve the state of the Baltic Sea and its biodiversity. The Baltic Sea is important both for the species involved in its unique ecosystem and the countries surrounding it. These countries are Finland, Denmark, Sweden, Germany, Poland, Lithuania, Latvia, Estonia and Russia, which are countries where also most of our customers are located at the moment. Due to the special hydrographical and climatic conditions, the Baltic Sea is especially vulnerable to changes and the natural environment of the Baltic Sea has degraded dramatically in the past years. By supporting BSAG we are able to give life to the Baltic Sea as a Christmas present. You can read more about BSAG and their Baltic Sea projects here.

Have a great Christmas season!

Best wishes, Ecobio team

The European Commission has approved the carcinogenicity classification of titanium dioxide dust

The European Commission approved the 14th technical adaptation of the CLP Regulation. It includes the classification of titanium dioxide as a Category 2 inhalation carcinogen. The substance is carcinogenic when inhaled in powders with a concentration greater than 1% and a particle size of titanium dioxide ≤ 10 μm.

The substance will then require a warning label with H351 warning phrase and a health warning pictogram. For mixtures a phrase EUH211 or EUH212 will be required. If approved by the European Parliament and the Council of Ministers, the Regulation is expected to be published in early 2020 and will enter into force 18 months after its publication. The change will have a major impact on the industry, as titanium dioxide is used extensively in for example paints, colours, plastics, paper and coatings, including those used in consumer products.

The European Parliament and the Council will have two months to raise any objection to the publication of the Regulation. If the Regulation proceeds without objection, the amendments to Annex VI to CLP will enter into force within 18 months of the publication of the Regulation.

Do you need help in monitoring your company´s chemical obligations or in implementing classification changes? Our chemical experts will help you!

We can also provide you with new compliant safety data sheet templates.

Contact us today:

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Ecobio helps you balance business and nature

October 2, 2019

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

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)

Need help with chemicals management? Learn more about the Ecobio Manager compliance tool.