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Voluntary information as part of Taxonomy-eligibility reporting

Last December, the EU’s Taxonomy Platform published considerations on voluntary information as part of Taxonomy-eligibility reporting, which gives supplementary guidance for disclosures.

In addition to mandatory reporting, voluntary reporting under the Taxonomy framework can enable non-financial companies and financial institutions to explain the eligibility proportion of their entire operations, investment profile, or balance sheet since it may include both Non-Financial Reporting Directive (NFRD) and non-NFRD companies, for example.

Voluntary disclosures should be made regarding the same scope and timeline as the financial and non-financial statements of the firm and in line with the reporting obligations. Voluntary reporting should be prepared on the basis that it does not contradict or misrepresent the mandatory information according to the disclosures delegated act, and it should not be given more prominence than the mandatory disclosures. Where an undertaking includes voluntary reporting, this should be accompanied with information on the basis used for its preparation and a clear explanation of how it differs from mandatory reporting.

Ecobio Manager – Our proposal for the first-period reporting

We provide a free trial account for Ecobio Manager’s Taxonomy classification and reporting tool for non-financial companies. By which, your team can disclose according to the first period’s requirements. The offering is valid until the end of March 2022. Its value is 3000 euros.

Act now! Please contact us and request your access to Ecobio Manager and book a demo presentation: sales@ecobiomanager.com.


Text: Sanna Perkiö

Source: https://ec.europa.eu/info/files/sustainable-finance-taxonomy-eligibility-reporting-voluntary-information_en

Define total turnover, Capital expenditure and Operating expenses, of the Taxonomy-eligible economic activities in non-financial companies

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Last December, The European Council adopted the Delegated Act (2021/2178/EU) related to Taxonomy methodology and disclosure obligations for financial and non-financial companies.

In 2022, non-financial companies shall disclose only information of Taxonomy-eligible activities for the environmental objectives of climate change mitigation and climate change adaptation.

From 1 January 2022 until 31 December 2022, non-financial undertakings shall only disclose the proportion of Taxonomy-eligible and Taxonomy non-eligible economic activities in their

  • total turnover,
  • capital expenditures, and
  • operational expenditures.

In addition, non-financial undertakings need to provide relevant qualitative information associated with the eligibility proportions.

Ecobio has published a whitepaper that provides more implementation guidance on the EU Taxonomy classification and reporting for non-financial companies. Please find the latest whitepaper here.

Upcoming for non-financial companies

In Q1/2021, the European Union will adopt

  • Taxonomy classification criteria for nuclear power and natural gas, and
  • Technical Screening Criteria for remaining environmental objectives.

Ecobio Manager – Our proposal for the first-period reporting

We provide a free trial account for Ecobio Manager’s Taxonomy classification and reporting tool for non-financial companies. By which, your team can disclose according to the first period’s requirements. The offering is valid until the end of March 2022. Its value is 3000 euros.

Act now! Please contact us and request your access to Ecobio Manager and book a demo presentation: sales@ecobiomanager.com.

With best regards,

Ecobio’s Taxonomy team

 

blankKatrine Hoset

Senior Consultant, Account Manager, PhD.

 

 

blankSanna Perkiö

Head of Innovations, D.Sc.

 

 

Malena WeurlanderMalena Weuerlander

Key Account Manager

Three steps for EU Taxonomy Reporting – Deadline coming soon

Three steps for EU Taxonomy Reporting – Deadline coming soon

Are you ready to report EU Taxonomy eligibility as a non-financial entity? In the EU, this year will be the first EU Taxonomy reporting period to disclose in 2022 for non-financial listed companies with over 500 employees on average during the reporting period (Prop. 2021/22:11).

During the first year, non-financial companies shall disclose the proportion of total turnover, total CapEx and total OpEx that consist of environmentally sustainable economic activities eligible with the EU Taxonomy. I.e., the activities within one of the defined categories for which the Taxonomy regulation provides sustainability criteria. Reporting on eligibility already in 2022 will ensure that companies required to report complete KPIs on Taxonomy alignment from 2023 will be better prepared for the work of classifying and defining the financial reporting level necessary to comply with the Taxonomy regulation.

Three steps for EU Taxonomy Reporting

The following three steps guides reporting for the first year:

Step 1. Economic activity. Identify each potential economic activity, including a subset of transitional and enabling economic activities

Step 2. Eligibility. Assess eligibility by comparing your economic activity with the Taxonomy defined activity category descriptions and NACE codes.

Step 3. Reporting KPIs. Report eligibility as the proportion of total turnover, total CapEx and total OpEx, including relevant contextual information on how eligibility has been determined and implemented in the necessary calculations.

The turnover KPI represents the proportion of the net turnover derived from products or services that are taxonomy eligible. The turnover KPI gives a static view of the company’s contribution to environmental goals.

The CapEx KPI represents the proportion of the capital expenditure of an activity that is either already taxonomy-aligned or is part of a credible plan to extend or reach taxonomy alignment. CapEx provides a dynamic and forward-looking view of companies’ plans to transform their business activities.

The OpEx KPI represents the proportion of the operating expenditure associated with taxonomy-aligned activities or the CapEx plan. The operating expenditure covers direct non-capitalised costs relating to research and development, renovation measures, short-term lease, maintenance, and other direct expenditures relating to the day-to-day servicing of property, plant and equipment assets that are necessary to ensure continued and effective use of such assets.

The European Council will make a final decision about the schedule on the 8th of December, 2021.

Digitalise your EU Taxonomy work process

With the deadline for the first reporting requirements regarding EU Taxonomy is approaching, it is beneficial to already from the beginning take advantage of the efficiency offered by digitalisation. 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.

With Ecobio Manager, you can turn the complex set of EU Taxonomy reporting requirements into a smooth and straightforward digital work process for your team. The digital solution includes a demanding entity of requirements always available and effectively managed. Our easy and comprehensive tool contains everything you need to meet the requirements of EU Taxonomy classification and reporting

Get expert advice and join our presentation

Presentation of our digital solution

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! During our 30 min presentation, we present our easy and comprehensive tool containing all you need to meet the EU Taxonomy classification and reporting requirements.

Register here!

Expert advice and personal demo account

Do you have questions regarding EU Taxonomy and need advisory? Do you want a presentation of our digital solution regarding EU Taxonomy? Contact our EU Taxonomy expert Katrine Hoset to get expert advice and an in-depth presentation of the comprehensive solution. Do not hesitate to ask our expert about a personal demo account to try out our platform.

Please get in touch with us

blankKatrine Hoset

Account Manager, Senior Consultant

katrine.hoset@ecobio.fi

+358 (0)20 756 2306

Read more about our EU Taxonomy digital solution here and our sustainable finance consultancy services here.

Safer Chemicals Conference 2021

Safer Chemicals Conference 2021

The European Chemicals Agency (ECHA) organized a virtual Safer Chemicals Conference on 6 October 2021. Ecobio attended the event.

The conference focused on the chemical strategy and several related themes, which will affect e.g. the chemicals legislation and substance restrictions. The goal is a non-toxic environment where chemicals contribute to society while avoiding harm to the environment and humans. Three core issues of the chemicals strategy are 1) increasing the protection of the environment and people 2) innovation and 3) simplifying and consolidating the current legal framework.

The issues raised by the conference presentations and speeches included:

  • New safe chemicals and materials are needed, and innovation is an integral part of it.
  • Definition and criteria for a sustainable chemical are needed. Criteria must be introduced.
  • Research funding should support the development of safe and sustainable chemicals.
  • The chemicals strategy is not only about sustainability, but also includes measures for the circular economy and digitalisation.
  • A full life cycle assessment of chemicals is needed to ensure safety and sustainability.

The presentations addressed the grouping of substances to speed up and harmonize restrictive measures, the replacement of hazardous solvents by less harmful ones, PFA restrictions, the new Clean Drinking Water Directive, and nanomaterials. In addition, PCN and SCIP notifications and changes made in relation to them were reviewed.

Additionally, one of the themes of the event was compliance. Conformity and enforcement of products and chemicals will be strengthened through more frequent checks. ECHA supports companies in compliance e.g. with informal reviews through the Voluntary Action Plan.

The new features of PCN notifications for hazardous mixtures were reviewed. For example, it is possible to make notifications for several mixtures at the same time, provided that they have the same classification. Discontinuation of the product may also be indicated in the notices. Furthermore, new situations where the notification needs to be updated were discussed. Updates have also been made to the PCN format and the submission of notifications has been improved, e.g. through the System-to-System (S2S) service.

Obligation for notifying on Substances of Concern In articles as such or in complex objects (Products) was discussed as well as the preparation of the notification, and the public SCIP database and its use. A SCIP notification or a Simplified SCIP notification (SSN) must be made for articles containing more than 0.1 % of any Substance of Very High Concern (SVHC). Companies’ challenges in the SCIP notification obligation include the relatively short notice that was given to prepare for the new obligation and gather the necessary information in complex supply chains. Despite the difficulties, a significant number of SCIP notifications have already been made to the SCIP database.

In addition, the concerns of the companies were heard in the discussions and chat rooms of the event. The following ideas were put forward:

  • Companies need clear criteria and direction to invest in as quickly as possible. It takes time to achieve the given goals and make the necessary changes.
  • There must also be a market for sustainable and safe chemicals. Companies may face questions such as: How much more can a sustainable chemical cost? How much of the product’s properties are allowed to deteriorate?
  • In companies, a decrease in the consumption of chemicals may mean a decrease in growth.

The materials and recordings of the event are available at ECHA’s website here.


Text: Anne Kallioinen & Mikael Hirn

Picture: Shutterstock

Poison Centre Notification – 6 Steps for a Successful PCN

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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 here.

Ecobio helps you to fulfil your obligations

Do you need help or wish to know more about your obligations or the poison centre notifications (PCNs)? Ecobio can help you to make Poison centre notifications and to collect the information required in notifications. Our experts will help you to meet your PCN obligations quickly and efficiently.

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

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

Eight new hazardous chemicals added to the SVHC Candidate List

Eight new hazardous chemicals added to the SVHC Candidate List

ECHA has added eight new entries to the Candidate List of substances of very high concern on 8 July 2021. Substances of Very High Concern (SVHC) may have serious and often irreversible effects on human health and the environment. There are currently 219 substances on the SVHC Candidate List.

Newly added substances are used in consumer products such as cosmetics, scented articles, rubber, textiles, solvents, flame retardants or to manufacture plastic products. Most of the substance have been added to the list due to their hazardous properties to human health.

Hazardous chemicals added to the Candidate List

Hazardous chemicals added to the Candidate List

Obligations related to SVHC

Companies have legal obligations if a substance included in the Candidate List is present in a concentration above 0.1% w/w. Obligations include:

  • Providing Safety Data Sheets for substances on their own and substances in mixtures containing SVHCs
  • Requirement to notify ECHA under REACH if an article contains a SVHC
  • Requirement to inform customers and consumers under REACH if an article contains a SVHC to allow safe use of the article
  • Requirement to notify ECHA under the Waste Framework Directive (SCIP Database) about articles containing SVHCs

Companies that are importing, producing, selling or using substances, their mixtures or articles (components, materials) containing SVHCs should keep an eye on the substances added to the Candidate List. Substances are regularly being added to the list. It is also recommended for companies to start looking for substitutes for the added substances already. Substances on the Candidate List may also be placed on the Authorization List in the future, which means that continuing the use would need a permission.

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. You can watch our webinar “Chemical Management and Risk Assessment Obligations” here. You can find all of our webinars here.

Interested? Contact us today!

Contact: info@ecobio.fi


Text: Mikael Hirn

Picture: Shutterstock

References:

ECHA: Candidate List updated with eight hazardous chemicals.

TUKES: Erityistä huolta aiheuttavat aineet (SVHC).

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.

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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

ECHA has opened a public consultation over eight potential substances of very high concern

kemikaalit ja aineet SVHC

ECHA has released proposals to identify eight chemical substances as Substances of Very High Concern (SVHC). Substances that may have serious and often irreversible effects on human health and the environment can be identified as SVHCs. If a substance is identified as an SVHC, it will be added to the Candidate List of REACH for eventual inclusion in the Authorisation List. Currently there are 211 substances on the SVHC Candidate List.

The proposed substances and examples of their use are:

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More information about the substances and links to comment are found at the ECHA website. The deadline for comments is 23 April 2021. Comments received on uses, and volumes per use, exposure, alternatives and risks will be taken into account in the authorisation process. Proposal and comments are referred to the Member State Committee (MSC) for agreement. If the committee does not reach a unanimous agreement, the matter is referred to the European Commission for a final decision. The substance is included directly in the Candidate List if no comments challenging the identification are received.

Obligations related to SVHC

Companies have legal obligations if a substance included in the Candidate List is present in a concentration above 0.1% w/w. Obligations include:

  • Providing Safety Data Sheets for substances on their own and substances in mixtures containing SVHCs
  • Requirement to notify ECHA under REACH if an article contains a SVHC
  • Requirement to inform customers and consumers under REACH if an article contains a SVHC to allow safe use of the article
  • Requirement to notify ECHA under the Waste Framework Directive (SCIP Database) about articles containing SVHCs

Companies that are importing, producing, selling or using substances, their mixtures or articles (components, materials) containing SVHCs should keep an eye on the substances added to the Candidate List. Substances are regularly being added to the list. It is also recommended for companies to start looking for substitutes for the added substances already. Substances on the Candidate List may also be placed on the Authorisation List in the future, which means that continuing the use would need a permission.

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

Sources:

ECHA Weekly – 10 March 2021. 

TUKES: Erityistä huolta aiheuttavat aineet (SVHC). 

Two new substances added to the SVHC Candidate List

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ECHA added the substances to the SHVC – Candidate List in January 2021

ECHA has added two new substances to the Candidate List of substances of very high concern (SVHC) due to their toxicity to reproduction. This means that the Candidate List now includes 211 substances. Any supplier of mixtures or articles containing a Candidate List substance above the 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. As of 5 January 2021, article suppliers have to notify substances of very high concern present in their articles to ECHA’s SCIP database under the Waste Framework Directive.

The added substances are: bis(2-(2-methoxyethoxy)ethyl)ether and dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety.

The substances are used in ink and toner products and in the manufacture of plastics and rubber tyres. The first substance, bis(2-(2-methoxyethoxy)ethyl)ether, acts as a solvent and extractant, and the mono-constituent form of the second substance (dioctyltin dilaurate) is used as an additive in the production of plastics and rubber tyres. The second substance is not registered under REACH as a group of substances. However, the constituent dioctyltin dilaurate is a registered substance.

The substances added by ECHA can cause serious effects on human health and the environment

The Candidate List includes substances of very high concern that may have serious effects on our health or the environment. These substances may be placed on the Authorisation List in the future, which means that companies would need to apply for permission to continue using them. (ECHA)

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.

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: Kristian Vaitomaa

Picture: Shutterstock

Source: ECHA