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Join our presentation of the world’s first comprehensive digital solution for the EU Taxonomy!

Join our presentation of the world’s first comprehensive digital solution for the EU Taxonomy!

Do you need help with EU Taxonomy classification and reporting? Join our presentation of the world’s first comprehensive digital solution for the EU Taxonomy!

Register here

Join us for a free 30 min presentation and we will show how the new section in our digital solution, Ecobio Manager, will help you to turn the complex set of EU Taxonomy requirements into a smooth and straightforward work process for your team.

With the requirements for the EU Taxonomy soon coming into effect, it is beneficial to have an innovative, efficient, and in-depth solution at hand, to get the process toward compliance started.

Join our presentation to learn:

  • How you can benefit from digitalization during classification and reporting
  • How our easy-to-use and comprehensive digital solution works
  • How to create a smooth and straightforward work process for your taxonomy team

During the event, you are also able to ask questions from our experts. Please register using your business email address.

The free online presentations are held on Wednesdays at 13.00-13.30 (UTC+2). You can find the presentation dates and register here

You are warmly welcome!

Read more and register here.

Are you unsure whether you are in or out of the EU Taxonomy classification and reporting requirements?

Take our EU taxonomy quiz and determine whether your company is affected by the EU Taxonomy regulation. Take the quiz here.

Our recorded webinars can be found on our homepage

In our webinar library, you can find our recorded webinars that you can watch whenever you find most suitable for you! You can find our webinar library here.

Poison Centre Notification – 6 Steps for a Successful PCN

Download our comprehensive guide about Poison Centre Notification here!

A large number of chemical products are placed on the EU market and used both by the general public in their everyday lives as well as by professionals in their working environments. Chemical products are, in general, considered to be safe when their use instructions are followed. Nevertheless, unintentional exposure to chemicals can occur, for example, due to their inappropriate use or accidents. When this happens, immediate access to relevant information on the chemical product is crucial for medical staff and those who provide emergency responses. Poison centres play an important role in ensuring the safe use of chemicals and formulating preventive and curative measures for poison incidents.

The companies that place hazardous mixtures on the market are obliged to provide information to the poison centres in each EU member state the placing occur. The placing on the market happens when the company, e.g. formulates or imports a mixture and either sells it or uses it in its own operations. This requirement is set by law in article 45 of the Classification, Labelling and Packaging (CLP)regulation ((EC) No 1272/2008). This obligation is applicable to mixtures,e.g. to detergents, paints, glues or biocides. Substances, e.g. ethanol, hydrogen peroxide, or copper sulphate, are not in the scope of this obligation as poison centres have the required information of substances available in their databases. The information provided enables poison centres to advise the citizens or medical personnel in an emergency.

PCN plays an important role in ensuring the safe use of chemicals and formulating preventive and curative measures for poison incidents

Our guide gives an overview of Poison Centre Notification (PCN) that play an important role in ensuring the safe use of chemicals and formulating preventive and curative measures for poison incidents.

Do you want to know what a Poison Centre Notification (PCN) is? Are you curious about which mixtures require information to be submitted and how to submit a Poison Centre Notification dossier? These are just some of the questions our guide answers as well as presenting the 6 steps for a successful PCN.

Download our guide by filling in the form below.



    By submitting the form, I agree to receive marketing communications regarding Ecobio and Ecobio Manager and their services, and I authorize Ecobio to store and process the personal data provided above to provide the requested content. You can unsubscribe from these messages at any time.


    Picture: Shutterstock

    Ecobio launched the world’s first comprehensive digital solution to comply with the EU Taxonomy Regulation

    Ecobio launched the world's first comprehensive digital solution to comply with the EU Taxonomy Regulation
    The Ecobio team at the launch event 29.9. From left: Taru Halla, Emma Björkqvist, Katrine Hoset, Sanna Perkiö & Evelina Meski

    The EU environmental classification legislation for sustainable finance, in short, EU Taxonomy Regulation, is a large-scale, regulatory-based framework that requires companies to define environmentally sustainable economic activities. The regulation is an EU tool to steer the economy towards sustainable development. Companies will have to meet the requirements gradually from the beginning of 2022.

    The EU Taxonomy Regulation obliges large, listed companies and companies operating in the financial markets to classify, assess and disclose their economic activities in accordance with sustainable development criteria. In the future, the Taxonomy Regulation will apply to a broader range of business entities.

    Companies are now preparing to comply with the requirements of the EU Taxonomy Regulation. To date, little assistance has been available for companies to assess the conformity of a large-scale classification system and to report data.

    Ecobio Manager aims to solve the EU Taxonomy challenge of over ten thousand companies

    Today, Wednesday, September 29, 2021, Ecobio announced the world’s first comprehensive and easy-to-use digital solution to meet the requirements of the EU Taxonomy Regulation. The solution is implemented as part of the Ecobio Manager SaaS service. Ecobio Manager is an environmental compliance tool for business operations, products, and subcontractors as a cloud service.

    – Ecobio Manager is the world’s first comprehensive taxonomy solution including a smooth classification process and up-to-date legal databases, as well as an environmental risk assessment protocol. So far, there has been no service with similar coverage in the global market, said Sanna Perkiö, D.Sc., founder, and the Head of Development of Ecobio.

    The EU Commission has created a complex system, which may result in companies getting lost in the requirement jungle without expert help and a systematic way of working.

    – We offer over ten thousand companies in the EU an easy and competent digital solution to meet the requirements of EU Taxonomy. Feedback from listed companies and the financial industry has been both enthusiastic and relieved.

    From the beginning, companies should take advantage of the efficiency offered by digitalization, Perkiö suggested.

    – The first requirements of the taxonomy must be reported as early as next spring. We expect wide interest and customers from all over Europe.

    Read more about our digital solution for EU taxonomy here.

     

    Webinar 29.9: Comply With the EU Taxonomy Regulation

    Are you trying to comprehend the EU Taxonomy regulation and what it means for your company? Do you want to find out the benefits of digitalisation in meeting the requirements? This event is for you.

    Register here!

    In our webinar, our senior consultant Katrine Hoset, PhD, will go through the EU Taxonomy Regulation and how financial and large companies can fulfil the new classification and reporting requirements in sustainability. The Taxonomy Regulation is already in force, and reporting against two of the objectives is required already in 2022 for the financial year of 2021. As the regulation is constantly being updated, we will present the newest details covered by the legislation.

    Additionally, we will launch Ecobio’s new digital solution to ensure compliance with EU Taxonomy classification and reporting requirements. We will present the new SaaS in Ecobio Manager that turns the complex set of requirements into a simple and smooth work process for your team. With the requirements for EU Taxonomy soon coming into effect, it is beneficial to have an innovative, efficient, and in-depth solution in mind already now to get the process toward compliance started. The launch includes a panel discussion among the creators of the tool, and questions from the audience will be discussed live.

    What

    Watch our event to learn:

    1. What the EU Taxonomy Regulation implicates
    2. What the current timeline for the Taxonomy looks like
    3. Which requirements apply to your company and when
    4. What the compliance process looks like
    5. About our new digital solution for EU’s Taxonomy Classification and Reporting

    During the event, you will get an opportunity to ask questions from our experts.

    To Whom

    The intended audience of this webinar is corporate board members and management teams in sustainability, finance, and communication. Both financial market participants (FMPs) and large companies that already need to provide a non-financial statement according to the non-financial reporting directive (NFRD) will be affected by the regulation.

    Are you unsure whether you are in or out of the EU Taxonomy classification and reporting requirements? Take our quiz and determine whether your company is affected by the EU Taxonomy regulation. Test here.

    When

    The free online event will be held in English on Wednesday, 29.9.2021, from 9.00-10.00. Timetable:

    • 9.00-9.30: Comply With the EU Taxonomy Regulation (webinar)
    • 9.30-10.00: Launch of Ecobio’s new digital solution to ensure compliance with EU Taxonomy classification and reporting requirements

    You can register here!

    Our recorded webinars can be found on our homepage

    In our webinar library, you can find our recorded webinars that you can watch whenever you find most suitable for you! You can find our webinar library here.

    Biocides in the European Union

    Biocides in the European Union

    Download our comprehensive whitepaper about biocides in the European Union here!

    It might not always be so obvious, but biocides belong closely to our everyday lives. They are products we use regularly, for example disinfectants, preservatives, insecticides, rodenticides, or repellents which kill, deactivate, render harmless or prevent the action of harmful organisms. Right now, the Covid-19 pandemic is still bothering the mankind making the biocides even more important to us than ever before – each one of us has used hand sanitisers and other disinfectants during this time.

    Biocides are important products, and we need them in our lives in various occasions. Biocides are regulated in the European Union (EU) by Regulation (EU) No 528/2012 on Concerning the Making Available on the Market and Use of Biocidal Products, often called simply Biocidal Products Regulation (BPR). The EU BPR regulation requires many elements and aspects to consider and fulfill in order for the biocidal products to be complaint with the EU-legislation and allowed to be sold and used on the EU-markets. In addition, different national regulatory practices apply making the fulfillment of all the requirements even more time consuming and tedious.

    Reach and maintain compliance with the EU Biocide Product Regulation

    Our whitepaper gives an overview of the European Union Biocide Product Regulation (BPR), the regulatory approval process of the biocidal active substances, and particularly of the authorisation process of the biocidal products in the European Union (EU).

    Do you want to know what the European Union Biocide Product Regulation (BPR) is? Are you curious about how the regulatory approval process of the biocidal active substances work and how the authorisation process of the biocidal products in the European Union work? These are just some of the questions our whitepaper answers as well as presenting how to run your biocide business smoothly.

    Download our whitepaper here.

    Ecobio helps you make your biocide business run smoothly

    Ecobio can provide you with valuable information on biocides as our consultants have a high knowledge of the BPR legislation and the regulatory practices of the biocides both at the national and the EU levels. We can guide you through the entire biocide authorisation process and assist you to make your biocide business to run smoothly. We are at your disposal and wait for you to tell us more about your biocidal products or biocidal active substances, your circumstances, and needs.

    Read more about our services regarding biocides here.

    Get in touch with us! We are very pleased to help you.

    Ecobio Oy asiantuntija Anne KallioinenAnne Kallioinen

    Senior Consultant

    anne.kallioinen@ecobio.fi

    Tel.: +358 20 756 2303

     


    Picture: Shutterstock

    How the EU regulatory context of the food contact materials and articles may change on our way to a toxic free environment − Over 44 years old EU rules under re-evaluation

    How the EU regulatory context of the food contact materials and articles may change on our way to a toxic free environment − Over 44 years old EU rules under re-evaluation

    The European Green Deal, Chemicals Strategy for Sustainability and Farm to Fork Strategy set the frame

    European Union’s Chemicals Strategy for Sustainability (CSS) from October 2020 paves our path towards a toxic free environment. This is one of the goals, the European Green Deal growth strategy sets to tackle pollution and climate change. The ambition of the Green Deal is that the European Union (EU) will become a sustainable climate neutral and circular economy by 2050. As the CSS, also the European Commission’s Farm to Fork (F2F) Strategy from May 2020 is a part of the Green Deal aiming at a fair, healthy and environmentally friendly food system. Food Contact Materials (FCMs) are specifically mentioned in both strategies. The CSS focuses to protect the public health with the goal that the consumer products, including food contact materials, do not contain the most harmful chemicals. European Commission (EC) commits itself through the F2F Strategy to improve food safety and public health by revising the current FCM legislation. The main targets are at reducing the use of hazardous chemicals, supporting the use of innovative and sustainable packaging solutions of environmentally friendly, re-usable and recyclable materials, and contributing to food waste reduction. For example, single-use food packaging and cutlery should be replaced by re-usable products.

    This blog intends to give you an overview of the main changes which the CSS and F2F Strategy may bring to the upcoming EU FCM regulations. Before giving the overview on the possible future FCM rules, the current EU regulatory framework of the FCMs and articles are described and discussed.

    What are Food Contact Materials (FCMs) and articles?

    Food Contact Materials (FCMs) are any materials which

    i) are already in contact with food, such as milk cartons, yoghurt tubs, lemonade bottles, chocolate wrapping papers and sausage casings,

    ii) are intended to be brought into contact with food, such as tableware, cooking utensils and food processing equipment, or

    iii) can reasonably be brought into contact with food or transfer their constituents to the food under normal or foreseeable use, such as serviettes, paper napkins or tablecloths (case-by-case basis).

    The FCMs and articles must be safe – both EU and national regulations apply

    The FCMs should be sufficiently inert, so that their chemical constituents do not adversely affect consumer health and the quality of the food. The safety of the FCMs must be assessed because their constituents can migrate into food. In the EU, European Food Safety Authority (EFSA) evaluates the safety of the FCMs based on the applications submitted by the applicants. Following the favourable outcome of the EFSA assessment, the EC authorises the use of the FCMs. Only authorised FCMs are allowed to be used in the EU. However, in practise this concerns mainly plastics as EFSA does not normally evaluate non-plastic based FCMs. Nor the non-plastic based FCMs undergo the EU-authorisation process and the national statutory rules and procedures apply.

    Currently the EU-wide harmonised FCM-legislation includes: The Framework FCM, Good Manufacturing Practise (GMP), some material specific (e.g. plastics, active and intelligent FCMs and ceramics), and some substance specific (e.g. bisphenol-A) regulations. For many different material types of the FCMs, such as paper, wood, printing inks, metals and glass, the national regulatory measures are applied, and no EU-wide harmonised legislation exists. The most commonly used of the latter ones are the German, French and Swiss national recommendations and regulations. Typically, national positive lists of the permitted chemical substances have been established by the different EU Member States (MSs). Recently, Germany updated its BfR-recommendations on FCMs and also indicated to set safety levels for mineral oil aromatic hydrocarbons (MOAH) in recycled food contact paper and cardboard. Where the national legislation applies, the principle on mutual recognition is used to bring the FCM or article approved by one EU MS for its national markets to the territories of the other EU MSs. Specifically in these situations, the National Food Safety Authorities can give useful advice on the national statutory requirements.

    Nonetheless, whether the specific material-related legislation exists or not, the EU’s FCM legislation requires that any material and article must be manufactured in compliance with the good manufacturing practices (GMP, Regulation (EC) No 2023/2006) and the Framework FCM Regulation ((EC) No 1935/2004) in a manner that any potential transfer of a chemical constituent to food does not

    i) endanger human health,

    ii) change the composition of the food in an unacceptable way, or

    iii) deteriorate the taste and/or odour of the food.

    Furthermore, the EU-legislation stipulates that the labelling, advertising and presentation of a material or article shall not mislead the consumers. These two pieces of legislation cover all types of food contact materials and articles regardless of whether the FCM or article is directly or indirectly in contact with food.

    Is my FCM active material?

    Figure 1 depicts how the FCMs (substances and articles) are situated in the EU-regulatory context, and which regulatory actors are involved. Naturally, the FCMs and articles have a direct link to food regulations (e.g., food additives, food flavourings and food contaminants). But the FCMs and articles are also covered by other food regulations, such as official food control enforced by the EU MSs to control the traceability of the FCMs and their safety, or the recent transparency regulation when seeking for the EU-authorisations for the FCMs (Figure 1). Food additives and flavourings incorporated into the FCMs, and articles must not be released and cause technical effects in or on the food. If they do so, the FCM or article is considered as an active FCM or article because it is non-inert. Only food additives and food flavourings authorised in the EU can be used in the active FCMs and articles. The active contact materials should extend the shelf-life of the packaged food by maintaining or improving its condition, by releasing substances to or absorbing substances from the food or its surrounding environment.

    FCMs under the REACH, CLP and BPR Regulations

    In addition to the food law, the important EU chemicals regulations, REACH and CLP, apply to the FCMs. European Chemicals Agency (ECHA) is the body who implements the chemicals legislation in the EU (Figure 1). The REACH registration, restriction, and authorisation obligations as well as the CLP-provisions are also required to be followed for the substances and mixtures used to manufacture the FCMs. If the substances of very high concern (SVHCs) on the RECAH Candidate List are present at concentrations greater than 0.1% w/w, a SCIP-notification under Waste Framework Directive (WFD) applies for the food contact articles, too. Biocidal Products Regulation (BPR) can apply in cases where biocides are incorporated into the FCMs and articles (Figure 1). As other chemical constituents, the biocides must not be released from the FCMs and articles at levels negatively impacting the human health and the food quality.

    Migration of the chemical FCM-constituents must be known

    The safety of the FCMs and articles must be guaranteed by the business operator (in practice typically a manufacturer), and migration of the chemical FCM-constituents (also non-intentionally added substances, e.g., impurities and reaction products) to food has to be determined either by mathematical calculations, modelling or migration testing. Many research institutes and laboratories specialised to these tests, modelling and calculations provide commercial services to the FCM-business in Europe. Based on the generated results, they also issue certificates for the compliance of the material with the FCM-legislation in the EU and internationally. The certificates are requested by the customers of the FCMs as well as local food inspectors. Dietary risk assessment of the migrating substances from the FCMs and articles to food should also be conducted by the manufacturers where the guidelines, recommendations and regulations stipulating the safe levels are absent.

    Figure 1: FCEM context

    Figure 1: Food Contact Materials (FCMs) and articles in their regulatory context in the European Union.

    Single-use plastics and other regulatory developments

    It is also good to bear in mind the other regulatory developments in the EU and worldwide, such as single-use plastics, under which many food contact articles fall, and the packaging waste which also regulates food contact materials and articles. Recycling has an important role in both statutory acts. It is worth noting that the food contact materials and articles made partly or fully from the recycled plastics can only be from those recycling processes which have been authorised in the EU following the EFSA risk assessment. It is foreseen that the new the FCM-legislation will be extended to include the re-use of all types of FCMs and recycling.

    From this July onwards, the EU MSs must ensure that certain single-use plastic products are no longer placed on the EU market. In May 2021, the EC published guidelines on the application of the single-use-plastic rules; for example, single-use biodegradable/ bio-based plastic products and paper-based products with plastic lining or coating fall under the single-use plastic definition. Overall, it is good to realise when considering the use of plastics, that also the global multinational food companies have large programmes to reduce the use of virgin plastics and enhancing their recycling. It is clear that the use of plastics will decline in the future, even though it is very vital packing material to keep our food safe in the increasingly complex global food and drink markets.

    Ongoing reassessment of the EU FCM legislation – how it may change?

    Since the establishment of the basic EU FCM legislation over 44 years ago, it has never been re-evaluated until now. This process started in 2017 and has revealed some concerns owing to the absence of the harmonised EU-level regulations for many other FCMs other than plastics. Several key problems have been identified, such as lack of focus on the final materials and articles while the current approach bases on positive lists, lack of prioritisation for the most hazardous substances and lack of encouragement to develop safer and sustainable alternatives. Since the inception of the re-evaluation, the strategies on the chemicals (i.e., CSS) and farm to fork (i.e. F2F) were published as noted in the introduction. The most relevant possible regulatory changes to take place for the FCMs and articles in the EU are summarised in Table 1. The Table also indicates whether this change is origin from the CSS.

    A shift from specific substances to final materials

    A shift from the focus on the safety of the chemical substances to the full characteristics of all final materials and articles is expected to be included in the revisited FCM-legislation. In this context the GMP rules will be strengthened, too. It is also considered to reduce the complexity of the packaging materials, including the number of materials and polymers used today.

    The CSS outlines a banning of the most harmful chemicals in consumer products including FCMs

    The CSS outlines that the most harmful chemicals are to be banned and thus phased out in consumer products for non-essential uses. The most harmful chemicals will only be allowed in the consumer products if their use is essential for the society and no alternatives are available. The CSS lists that the FCMs and articles are among the consumer products which will be ensured to be free from substances causing cancers or mutations, affecting reproductive and endocrine systems, or being persistent and bioaccumulative by applying generic risk management. The CSS further outlines that this approach could be extended to the chemicals exerting other types of adverse effects later-on. How the “essentiality for the society” regarding the use of harmful chemicals in the FCMs will be considered in the future is to be seen. The question arises though, are the FCMs and articles considered essential for the society?

    All substances, including non-intentionally added substances, and mixtures that may pose a health risk to consumers are envisaged to be considered in the new FCM legislation. Tiered approach to prioritise the assessment of these substances will be used. The most harmful chemicals (carcinogenic, mutagenic and reprotoxic substances (CMRs), endocrine disruptors (EDs), persistent, bioaccumulative and toxic substances (PBT and vPvBs) are in the first tier, and the other specific substances (e.g., nano-forms) are in the second tier. The official EU risk assessment bodies ECHA and EFSA are to conduct the assessments for these substances, while the third-tier substances can be self-assessed by the business operator. The latter ones are the least of concern and those which migrate at low levels. A generic approach based on the hazardous properties (e.g., carcinogenicity) will be used to prioritise the substances, with certain defined exceptions. These exceptions may include the FCMs if considered essential.

    Chemicals to be assessed as groups

    The CSS also describes that grouping of chemicals with similar properties (hazard, structure, risk and/or function) will be used to assess the substances instead of regulating them one-by-one. This could mean for example that a group of chemicals with similar hazardous properties are banned or restricted in one go. This will impact also the chemicals used to manufacture the FCMs. The SCC emphasises the phase out of PFAS as a group, this includes their use also in the FCMs (unless essential for society). Some RECAH restriction intentions already exist for PFAS. Netherlands, Denmark, Germany, Norway, and Sweden are working on a proposal for a European-level ban of PFAS. Recently, at the national level Denmark banned the use of PFAS-substances in food contact paper and cardboard, and articles thereof.  Bisphenol A and its structurally related analogues as well as phthalates could also be such groups to be restricted or banned in the near future.

    The ban of endocrine disruptors in consumer products is specifically highlighted in the CSS and it is likely that none of them are allowed to be used in the FCMs in the future. The CSS details that criteria to identify endocrine disruptors need to be included also in the FCM legislation. The criteria have already been defined for the biocides and plant protection products regulations. The upcoming RECAH and CLP revisions both foresee the introduction of endocrine disruptors in them. Endocrine disrupting substances are of high concern also at the national level in Europe. For example, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) has identified 16 priority substances to be assessed urgently for their endocrine disrupting properties.

    One-substance-one-assessment for FCMs jointly done by ECHA and EFSA

    The CSS also sets out a principle of one-substance-one-assessment. For the FCMs this means that EFSA and ECHA will assess the FCM-substances and mixtures in a close cooperation. The FCMs are the first common regulatory area of EFSA and ECHA where one-substance-one assessment is applied. Interesting is to see how this will work out in practice as generally EFSA bases its assessments on risks, while ECHA bases its assessments on hazards. Could there be of a concern that restricting or banning of substances, or a group of substances based on hazards assessed by ECHA occurs far before than any FCM-application has been submitted to EFSA for the assessments of the dietary risks? It needs to be kept in mind that the REACH obligations for substances and mixtures are to be obeyed prior to the manufacturing of the FCMs can start and any FCM-application is submitted to EFSA. Therefore, it might be that the RECAH-level identification of the substances and mixtures of concern will become more influential in the future than the EFSA-level dietary risk assessment in the future. It could be anticipated that the EFSA risk assessments will continue only for those FCMs which have not been identified for a ban by ECHA or for those which have been derogated from the bans.

    In addition to EFSA-ECHA joint work with the FCMs and REACH, they also cooperate with FCMs and biocides. In March 2021, they published a joint document where the two bodies identified several differences in their risk assessments for silver compounds used as biocidal active substances in the FCMs. Currently, EFSA, ECHA and EC are jointly defining the procedures and best practises for the one-substance-one assessments. Time will tell how this will function.

    Mixtures of substances are of a high interest

    The adverse effects from mixtures of chemical substances, so called “cocktail-effects”, are also to be considered within the EFSA risk assessments on the FCMs. In the recent past, EFSA has published several guidance documents and other information on the chemical mixtures. Many international developments are ongoing on the chemical mixtures. The mixture assessment factor is also to be introduced in the revised REACH for the safety assessment of the chemicals as outlined by the CSS. The chemical mixtures are currently a hot scientific and regulatory topic, and certainly FCMs are to be impacted by these developments.

    Polymers to be registered under REACH

    The CSS specifically draws attention to polymers, as today they are not subject to registration under the REACH. Therefore, in the updated REACH, the registration of polymers of toxicologically concern is foreseen. This will naturally, one way or other, have an influence on the plastic-FCMs. Furthermore, the REACH will be amended on information requirements irrespective of the manufactured or imported volume of the chemicals to enable the identification of critical hazardous properties also for the low and medium tonnages. Some other recent scientific developments have indicated that other types of polymer-materials, such as cellulose and bio-based plastics, manifest some toxicological effects. Whether the new FCM-plastic legislation is extended also to these chemicals is to be realised.

    Declaration of Compliance (DoC) to be introduced for all types of FCMs

    Clear and consistent regulatory rules for the data requirements as well as the rules for the information transfer through the supply chain will be set in the updated FCM-regulations. This is to improve the information flow. The requirement for the business operator to issue a Declaration of Compliance (DoC) will be introduced for all types of FCMs. Presently, coatings, printing inks and adhesives are not subject to the requirement of a DoC, except when used in plastic materials and articles. For the other FCMs, the DoC needs to be provided as dictated by the FCM Framework Regulation. A DoC structure is available in the current plastic regulation.

    New business opportunities to develop safe and sustainable FCMs

    The newly developed chemicals need to be safe and sustainable by design as presented by the CSS. Therefore, safer, and more sustainable alternatives are to be promoted, and the EC anticipates revising the FCM legislation including specific new rules on the safety of more sustainable production sources and methods. The EC will also provide incentives to produce safe and sustainable FCMs, e.g., using bio- and plant-based technologies. Thus, EU-funding will be available to research and develop new greener food contact materials. Furthermore, the FCM-legislation will be expanded to include the re-use of all types of FCMs and recycling. The FCM sustainability could include the aspects, such as the amount of energy used in the FCM-manufacturing and its renewability, extended self-life of the food due to the use of new FCM-types, reduced use of raw materials, re-use, and recycling of the FCM and the overall environmental footprint of the FCM. It is likely that these considerations will also be taken into account in the future assessments of the FCMs. Table 1 lists the main expected regulatory changes in the updated FCM and articles legislation.

    Table 1: The main possible regulatory changes to take place in the updated FCM and articles legislation in the European Union.

    Two possible ways to move forwards in the new FCM-legislation

    Two possible ways to move forwards in the new FCM-legislation have been proposed by the EC: either to revise the current regulatory framework (to have Regulation (EC) No 1935/2004 as a corner stone) or to develop a new regulatory framework, replacing the current regulation. Time will tell which option the EC and the EU MSs will choose. It is planned that the EC will adopt the new FCM-legislation by the end of 2022. However, delays may occur. New provisions are also anticipated to be added to the Official Food Control Regulation to establish new delegated bodies to carry out inspections and enforcement of the FCM rules. A system will be developed to verify the compliance with the FCM-legislation. It is yet to be seen how this will evolve.

    Finally, I hope this blog shed some light on the upcoming revisions and adjustments in the EU’s FCM regulatory field. I wish you found some food for the thought and that this blog fed you to think about what may lie ahead. Below you find some further reading on the new regulatory developments and the references on which the text above bases.

    As you just read, many changes will take place in the food contact materials and articles legislation in the coming years. Under the current European growth strategy Green Deal, many of these evolvements will be inevitable. Therefore, stay tuned, follow the Ecobio websites, use our Ecobio Manager to keep up with the regulatory changes and contact us for your open questions!

    Further reading

    Ecobio Services. Available at: https://ecobio.fi/en/#services

    European Chemicals Agency (ECHA). Chemicals Strategy for Sustainability. Available at: https://echa.europa.eu/hot-topics/chemicals-strategy-for-sustainability

    European Chemicals Agency (ECHA). EU Chemicals Legislation Finder. Available at: https://echa.europa.eu/legislation-finder?utm_source=echa.europa.eu&utm_medium=display&utm_campaign=customer-insight&utm_content=banner

    European Chemicals Agency (ECHA). Previous calls for comments and evidence https://echa.europa.eu/previous-calls-for-comments-and-evidence

    European Chemicals Agency (ECHA). Restriction of per- and polyfluoroalkyl substances (PFAS) under REACH.

    Available at: https://echa.europa.eu/documents/10162/31366392/pfas_webinar_slides_en.pdf/361234ba-5b0c-d5d0-df0d-4145c3e08c73

    European Commission (EC). Evaluation and Revision of EU Rules, Revision of EU Rules on FCMs. Available at: https://ec.europa.eu/food/food/chemical-safety/food-contact-materials/specific-eu-policy-initiatives/evaluation-and-revision_en

    European Commission (EC). Food Safety, Food Contact Materials. Available at: https://ec.europa.eu/food/food/chemical-safety/food-contact-materials_en

    European Commission (EC). Guidance on the application of Single-Use Plastic rules. Available at: file:///C:/Users/Mari.Eskola/Downloads/Questions___Answers_-_Guidance_on_the_application_of_Single-Use_Plastic_rules.pdf

    European Commission (EC). Technical Regulation Information System (TRIS) Database, Twenty-second Ordinance amending the Consumer Goods Ordinance, Germany. Available at: https://ec.europa.eu/growth/tools-databases/tris/en/search/?trisaction=search.detail&year=2020&num=510

    European Food Safety Authority (EFSA). Chemical mixtures. Available at: https://www.efsa.europa.eu/en/topics/topic/chemical-mixtures

    European Food Safety Authority (EFSA). Food Contact Materials. Available at:  https://www.efsa.europa.eu/en/topics/topic/food-contact-materials

    Executive Order on Food Contact Materials and Penal Code for Violation of Related EU Acts, Denmark. BEK nr 681 af 25/05/2020. Available at: https://www.retsinformation.dk/eli/lta/2020/681

    French Agency for Food, Environmental and Occupational Health and Safety (ANSES). Accelerating the assessment of endocrine disruptors. Available at: https://www.anses.fr/en/content/accelerating-assessment-endocrine-disruptors

    German Federal Institute for Risk Assessment (BfR). Database BfR Recommendations on Food Contact Materials. Available at: https://bfr.ble.de/kse/faces/DBEmpfehlung_en.jsp

    Keller & Heckman. EU Chemicals Strategy for Sustainability and Its Impact on Packaging Webinar. Available at: https://www.khlaw.com/events/eu-chemicals-strategy-sustainability-and-its-impact-packaging-webinar

    Zimmermann et al. 2020. Are bioplastics and plant-based materials safer than conventional plastics? In vitro toxicity and chemical composition. Available at: https://www.sciencedirect.com/science/article/pii/S0160412020320213


    Text: Mari Eskola, Dr, Senior Consultant, Ecobio Chemicals Team

    Pictures: Shutterstock & Ecobio

    The EU Taxonomy and KPIs

    The EU's Taxonomy and KPIs

    The European Commission has published a draft version of a Delegated Act to supplement article 8 in the Taxonomy Regulation (EU) 2020/852. This supplementation specifies the content and presentation of the information concerning environmentally sustainable economic activities and specifies the methodology to comply with that disclosure obligation.

    EU strives to channel capital towards sustainable investment

    One of the key objectives of the European Commission’s action plan on financing sustainable growth is to reorient capital flows towards sustainable investment and ensure market transparency. To achieve this, EU Taxonomy (EU 2020/852) was created, a classification system for sustainable activities. The EU Taxonomy is a robust and science-based tool for companies and investors that provides criteria for determining which economic activities substantially contribute to the Green Deal objectives.

    EU Taxonomy KPIs to help understand companies’ sustainability

    The drafted Delegated Act further specifies the content, methodology, and presentation of the information in the Taxonomy Regulation. The Delegated Act allows companies to translate the technical screening criteria of the Climate Delegated Act (and in the future Environmental Delegated Act) into quantitative economic performance indicators, KPIs, which will be publicly disclosed. This helps investors and the public to better understand the companies’ impact towards sustainability trough the annual publication of their KPIs. This will increase transparency on the market and help prevent greenwashing.

    The Taxonomy Regulation and the published Delegated act complement the NFRD (Non-Financial Reporting-Directive) and SFDR (Sustainable Finance Disclosure Regulation) by providing a common reference point for reporting the degree of alignment with sustainable activities.

    Market fields receive separate instructions for reporting

    The Taxonomy-related disclosures will create an entire ecosystem of sustainable finance tools, including standards, labels, and access to a coherent and relevant set of sustainability data. These on the other hand are necessary to channel capital towards the investments needed to reach the EU’s sustainability goals.

    The Delegated Act includes separate instructions for different market fields regarding sustainable reporting with KPIs. These fields are non-financial undertakings, asset managers, credit institutions, investment firms, and insurance and reinsurance undertakings.

    The drafted delegated act was open for feedback until 2 June. A lot of the feedback highlights the need to simplify and clarify the KPIs that should be reported, inconsistencies between reporting deadlines and availability of data, and a potential need for a longer transition period before reporting starts. Commentaries have also commented on the need to better align the reporting scope and application timelines in this delegated act with the CSRD (Corporate Sustainability Reporting Directive, the proposed amendment of the NFRD).

    The challenge of reaching compliance with the Taxonomy Regulation

    Many of the respondents that commented on the Commission’s publishment mentioned the challenge of collecting Taxonomy compliance data within companies and assigning this data to specific business lines. Ecobio’s sustainability experts familiar with the Taxonomy requirements and experts in EHS requirements will help your company meet the expectations of the Taxonomy Regulation. Ecobio’s sustainable finance services helps you to identify your sustainable economic activities and report your alignment with the Taxonomy. Read more about our services regarding Sustainable Finance here!

    With our Ecobio Manager legislation compliance tool, companies can assess compliance with the do-no-significant-harm requirements and minimum safeguards as well as follow up on relevant legislation development. Read more about Ecobio Manager here!

    Do you want to hear more? Kindly contact us:

    Katrine Hoset

    Katrine Hoset

    Account Manager, Senior Consultant

    katrine.hoset@ecobio.fi

    +358 (0)20 756 2306

    EU Taxonomy classification and reporting in 2023 – Eight steps to compliance – whitepaper

    This whitepaper aims to provide implementation guidance on EU Taxonomy Classification and Reporting requirements valid from 2023. The document deals with the actions needed by companies in the non-financial sector. Read the latest whitepaper to learn more about:

    • What is the EU Taxonomy Regulation?
    •  Which companies are required to act now?
    •  Eight steps for compliant EU Taxonomy classification and reporting from 2023

    You can download our whitepaper here!


    Text: Emma Björkqvist

    Picture: Shutterstock

    Five Steps to Comply with the Taxonomy Regulation

    Five Steps to Comply with the Taxonomy Regulation

    DOWNLOAD OUR COMPREHENSIVE AND CONCISE WHITEPAPER TO LEARN THE FIVE STEPS NEEDED TO COMPLY WITH EU’S TAXONOMY REGULATION HERE!

    Through the European Green Deal, EU aims to improve the well-being and health of citizens, make Europe climate-neutral by 2050, and protect, conserve, and enhance EU’s natural capital and biodiversity. Reaching these goals require a financial system that is more sustainable than it is today as EU aims to channel private investment into the transition to a climate neutral, climate resilient, resource-efficient, and fair economy. The EU’s Sustainable Finance package is one of the instruments of the EU Commission for delivering the policy objectives defined under the European Green Deal, and for delivering on EU’s international commitments on climate and sustainability.

    To accommodate the need for a more sustainable finance sector, EU released the EU Taxonomy Regulation on the 12th of July 2020. The EU Taxonomy Regulation and EU’s Sustainable Finance Strategy was strengthened with the release of the Sustainable Finance Package on the 21st of April 2021. The package included, among others, the release of the EU Taxonomy Climate Delegated Act and a proposal for a Corporate Sustainability Reporting Directive which revises the NFRD.

    The EU Taxonomy is a robust and science-based tool for companies and investors that provides criteria for determining which economic activities substantially contributes to the Green Deal objectives. The criteria also provide a common language that allows companies and investors to communicate credibly about green activities and assist the transition to a low-carbon economy.

    Reach and maintain compliance with EU’s Taxonomy Regulation in a constantly moving situation

    We have published a comprehensive and concise free whitepaper that helps your company reach and maintain compliance with EU’s Taxonomy Regulation in a constantly moving situation.

    Do you want to know what the EU’s Taxonomy Regulation implicates and who are affected by it? Are you curious about the current timeline and what requirements apply to your company? These are just some of the questions our whitepaper answers as well as presenting the five steps to meet the requirements!

    You can download our whitepaper here!

    Ecobio helps meet the Taxonomy Requirements

    Do you need expert help? Do you consider software solutions? Ecobio’s sustainability experts familiar with the Taxonomy requirements and experts in EHS requirements will help your company meet the expectations of the Taxonomy Regulation. Ecobio’s sustainable finance services helps you to identify your sustainable economic activities and report your alignment with the Taxonomy. Read more about our services regarding Sustainable Finance here!

    With Ecobio Manager legislation compliance tool, companies can assess compliance with the do-no-significant-harm requirements and minimum safeguards as well as follow up on relevant legislation development. Read more about Ecobio Manager here!

    Do you want to hear more? Kindly contact us:

    Katrine Hoset

    Account Manager, Senior Consultant

    katrine.hoset@ecobio.fi

    +358 (0)20 756 2306


    Text: Katrine Hoset & Emma Björkqvist

    Picture: Shutterstock

    Ecobio’s key take-home messages from the Helsinki Chemicals Forum 2021

    This year’s Helsinki Chemicals Forum (HCF) took place virtually on the 27th and 28th of April. Ecobio also joined the Forum as probably many of you too. In this brief blog we would like to share with you what we got out of the lively discussions during the two days. In these take-home messages, we concentrate in the EU’s Chemicals Strategy for Sustainability. This is because it was by far the most heavily debated topic at the HCF.

    As we all know, the EU’s new growth strategy, the European Green Deal, has set the European Union (EU) to become a sustainable climate neutral and circular economy by 2050. Therefore, it sets the goals to tackle pollution and move towards a toxic-free environment. The EU’s Chemicals Strategy for Sustainability (CSS), published in October 2020, is part of this scope. Not only because the chemical manufacturing industry is the fourth largest sector in the EU, but also because the chemicals are used in 95% of all manufactured goods.

    Safe and sustainable-by-design to protect human health and the environment

    The future chemicals have to be safe and sustainable-by-design, the CSS outlines. Although the actual meaning of this is yet to be defined in the EU, the debate during the HCF was around the following lines. New green chemistries need to be developed and used to produce new types of molecules to replace the most harmful current ones. The safe and sustainable-by-design concept needs to go through the entire life cycle of the chemical. For example, at the sourcing stage of the raw materials, the workers’ safety and human rights need to be adhered, and similarly at the manufacturing stage, too. The manufacturers also need to produce their chemicals, materials, and products environmentally friendly, e.g., by using renewable energy sources.

    The safe use of the chemicals, materials and products must be guaranteed. In the final stage of their life cycle the waste must be recycled in a manner that contributes to the circular economy. Information and transparency from the start to the end of product’s life are the key. Currently, we do not know anything about 70% of the chemicals, which was reminded at the HCF. Some speakers pointed out that without the right information through the entire product-chain we would not know how to appropriately recycle the waste in the end, in particular of the long-lasting materials such as concrete. As a starting point to improve this and to enable consumers to make informed choices, ECHA is going to make the data in its SCIP-database publicly available by the end of this year.

    Innovation and funding are prerequisite for the new developments

    The CSS promotes innovation to develop the new chemicals of safe and sustainable-by-design. It was made clear during the HCF discussions that funding is needed at all fronts from the development to manufacturing until the waste management. The EU will provide funding for these innovations; they could be e.g., new green chemistries, new greener technologies at the manufacturing sites or novel ways to decontaminate waste.

    Voices were heard at the HCF that funding is highly important. Concerns were raised how competitive the EU’s future chemicals sector would be if the non-EU-economies do not follow similar green strategies. It was also pointed out that chemicals sector will face many challenges simultaneously between now and 2050: green and digital transition challenge, circularity challenge and CSS. The CSS is a bigger regulatory update than REACH ever was, some HCF speakers noted. It was acknowledged, however, that the CSS gives a great opportunity for the EU’s chemical industry to be a global front-runner.

    Essential use of the chemicals is the way forward

    The CSS brings forward the concept on the essential use of the chemicals. Again, this is yet to be defined by the EU. Nevertheless, it was discussed in the HCF that in the evaluation process of the chemicals, the essentiality of their uses should also be assessed. The CSS outlines that the essential use must be a justified use where the most harmful chemicals are only allowed if their uses are necessary for health, safety or are critical for the functioning of society, and if there are no alternatives. Examples were given from the medical device sector; while the same harmful chemical used in a medical device could be considered essential, in the consumer products it should be banned.

    The CSS clearly aims at ensuring with the generic risk management approach that consumer products such as food contact materials, toys, childcare articles, cosmetics, detergents, furniture, and textiles, do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative. To empower this, the substances will be assessed and regulated in groups, instead of one-by-one. This will speed up the assessments made by ECHA, and consequently increase the number of restricted substances. Concerns were raised by some HCF speakers, whether this approach to regulate chemicals in groups would lead to omission of the essential uses of some specific chemicals. Time will tell.

    PFAS and endocrine disrupters in the spotlight

    Special attention is given by the CSS to PFAS and endocrine disruptors (EDs). The aim is to ban the use of PFAS as a group in the EU, unless proven essential for the society. As regards to the EDs, their all non-essential uses will be banned in the consumer products. The discussions are ongoing to introduce a new hazard class on endocrine disruptors in the CLP-regulation, based on the WHO definition, but building on the present criteria currently applied to pesticides and biocides. At the HCF, it was asked whether this new class would effectively be better to be added to the UN’s GHS to avoid the differences.

    REACH will be re-opened in 2022

    To allow the regulatory changes described by the CSS, the REACH-regulation will be revisited and amended accordingly. Information requirements are expected to increase. The CSS points to the direction to extend the REACH scope to cover certain polymers of concern, such as with CMR or ED properties. Also, information on the overall environmental footprint of the chemicals (e.g., emissions of greenhouse gases) would be required and more information will be needed to enable effective identification of the critical hazards of the substances (e.g., neurological effects).

    The future REACH will also require data to enable identification of all carcinogenic substances manufactured or imported into the EU irrespective of their volumes. Furthermore, compliance of all REACH-registration dossiers is required. This is to strengthen the principles of “no data, no market” and the “polluter-pays”. In case of non-compliance, the registration numbers will be revoked. Mixtures of the chemicals will also be introduced in the updated REACH, considering also other relevant legislation. E.g., food additives, food contact materials, water, cosmetics, and detergents. To involve the other regulatory sectors better, one-substance-one-assessment approach will be employed by building the new assessment on the previous assessments of the substance. Finally, the ongoing discussions on the introduction of the worker safety legislation into REACH were further reiterated at the HCF.

    This is what we at Ecobio found to be the most relevant discussion points at HCF 2021. Hope you enjoyed the reading. Next HCF will be held in March 2022 and thereafter every second year. You can find the CSS here and the CSS action plan here.

    Do you 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!

    You can contact us through email at info@ecobio.fi or by phone +358 20 756 9450.

    You might be interested in our chemical management webinar on Thursday 6.5.2021

    Welcome to our webinar regarding the digital future of chemical management on Thursday the 6th of May 2021. In our webinar our we summarize chemical risks for companies as well as their management in the workplace. Our experts present the most common challenges and digital solutions regarding complying with chemical laws. Additionally we go trough managing the use of chemicals and assessing the risk of chemical exposure. The webinar is held in both Finnish, Swedish, and Norwegian.

    Read more and register using the links below:

    You can find all of our upcoming and recorded webinars from our webinar library here!


    Text: Mari Eskola, Dr, Senior Consultant

    Picture: Shutterstock

    ECHA extends the scope of completeness check to include chemical safety reports

    The Technical Completeness Check (TCC) done by ECHA for each REACH registration dossier now includes manual checks on the content of chemical safety reports. The extended completeness check will apply to both new registrations and updates of existing ones. Implementation of the revised completeness check was originally planned for November 2020 but was postponed until 2021. This TCC improvement aims to enable better prioritisation of substances for regulatory action by authorities and to improve supply chain communication. Companies are responsible for registering substances that are manufactured or imported above one tonne a year.

    What is completeness checking?

    ECHA carries out a TCC on each incoming registration dossier to ensure that all required information is provided. The completeness check includes a manual verification which means that ECHA checks certain elements of the registration dossier that cannot be checked automatically. The TCC process, applied to all registration dossiers submitted to ECHA, previously included only the following elements:

    • Substance identification
    • Data-waiving justifications
    • Testing proposals on vertebrate animals
    • Justification for opting-out
    • Specific requirements for nanoforms

    As of 1 March 2021, manual completeness checks performed by ECHA staff will be extended to chemical safety reports to ensure they contain all the elements required under REACH.  A chemical safety report is required for all substances subject to registration in quantities of 10 tonne a year or more per registrant. Exposure assessment and risk characterisation are checked from chemical safety reports. Since the chemical safety report is submitted as a text document attached to the IUCLID dossier, the information cannot be verified by the Validation assistant. This makes verifying the completeness of a dossier before submitting more difficult. Registration dossiers sent before 1 March 2021 are not checked for the new TCC rules.

    Registrants should, therefore, prepare for the changes, as their update registrations may no longer pass the revised technical completeness check. If your first submission fails the TCC, you will get four months to correct the information. If your second submission is also incomplete, your submission will be rejected, and the data will not be included in ECHA’s database. ECHA will not refund or otherwise credit any fees before the rejection.

    More information

    Technical Completeness Check: https://echa.europa.eu/technical-completeness-check

    ECHA’s webinar on the revised completeness check: https://echa.europa.eu/-/revised-completeness-check-what-changes-and-how-you-can-prepa-1

    Do you 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


    Text: Mikael Hirn

    Picture: Shutterstock

    Source: ECHA