ECHA has submitted a restriction proposal for microplastic particles that are intentionally added to mixtures used by consumers or professionals. If adopted, the restriction could reduce the amount of microplastics released to the environment in the EU by about 400 thousand tonnes over 20 years.
Helsinki, 30 January 2019 – ECHA has assessed the health and environmental risks posed by intentionally added microplastics and has concluded that an EU-wide restriction would be justified. If adopted, the restriction could result in a reduction in emissions of microplastics of about 400 thousand tonnes over 20 years.
ECHA’s assessment found that intentionally added microplastics are most likely to accumulate in terrestrial environments, as the particles concentrate in sewage sludge that is frequently applied as fertiliser. A much smaller proportion of these microplastics is released directly to the aquatic environment.
The Candidate List of substances of very high concern (SVHCs) for authorisation now contains 197 substances.
ECHA has added five new substances to the Candidate List due to the carcinogenic, toxic to reproduction, persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) properties of the substances.
One further substance has also been added to the list having been identified as an SVHC by the European Commission due to its endocrine-disrupting properties. The Commission’s decision follows the referral of the MSC opinion on this SVHC proposal in 2016.
Chementors held a seminar at VCCI Tower, Hanoi in association with Vietnam Chamber of Commerce and Industry. Vietnamese Chemical Agency Vinachemia was also invited to inform about the implementation of Global Harmonising System in Vietnam.
The Vice Chairman of VCCI, Mr. Hoang Quang Phong, and the ambassador of Finland in Vietnam, Mr. Kari Kahiluoto, were the opening speakers in the seminar on EU chemicals regulation addressed to the Vietnamese trade and industry cluster, held on November 16th, 2018.
Chementors’ CEO Mr. Jani Määttä and COO Mr. Jan Nylund had two presentations each during the three-hour seminar. The REACH regulation and declaration of compliance and enforcement were two of the major topics covered in the seminar. Important information on European chemicals legislation was given, but also important national regulations in Vietnam were covered.
Despite the strict organizing schedule, VCCI managed to gather a substantial number of participants to receive important information, which might prove to be useful in the future when the EVFTA EU-Vietnam free trade agreement in the EU Parliament is ratified. The event was nationally reported by newspapers and television.
Chementors would sincerely like to thank the VCCI organization for making this happen, Vinachemia for their participation, and all the participants in the seminar. In addition, we would also like to convey our appreciation to the Vice Chairman of VCCI and the ambassador of Finland for their opening addresses.
The KemiDigi project (digital chemical data management) involves collecting information on chemicals in one place and simplifying companies’ obligations to submit information on chemicals. Among other things, companies can use the system to submit chemical notifications on the chemicals they have placed on the market and maintain the chemical lists they require for permits and monitoring etc. The chemical ratio calculator for determining the operating level of chemical plants (Act on the Safe Handling and Storage of Dangerous Chemicals and Explosives) will also be moved to KemiDigi in connection with the chemical lists.
The KemiDigi pilot has ended for companies
KemiDigi was piloted in two parts. During the summer, companies tested the submission of chemical notifications through KemiDigi. Testing of the list of chemicals was performed in October. Companies have given encouraging comments and useful feedback on the pilots. They have given constructive comments and development ideas for KemiDigi.
Introduction of KemiDigi
KemiDigi will be introduced in two parts in early 2019. The submission of chemical notifications will begin in February and the list of chemicals will become functional in April 2019.
The collection of quantity information from chemical notifications for 2018 will not, on this occasion, be carried out at the beginning of March, but through KemiDigi at a time to be announced later.
Due to the introduction of KemiDigi, the current e-mail submission of chemical notifications to the Chemical Product Register will end on 30 November 2018. After then, notifications can be submitted to
KemiDigi in February 2019. Chemical notifications submitted by the end of November will be transferred from the old system to KemiDigi and all valid notifications will be available to companies.
The list of chemicals held by Tukes for supervision in accordance with the Act on the Safe Handling and Storage of Dangerous Chemicals and Explosives will mainly be moved to KemiDigi in the early part of the year. In this way, they will form a basis for the chemicals list in KemiDigi, when economic operators log into KemiDigi for the first time. The exception is the list of chemicals that do not yet have classifications under the CLP regulation.
Guidelines on KemiDigi and its use will be provided in a range of formats prior to the introduction of the application. Written guidelines, video clips and live events are forthcoming.
Chementors Ltd had an honor to attend “We Love Finland” event in Ho Chi Minh City, Vietnam on Thursday October 18th. The center of the event organized by Business Finland was the Minister of Economic Affairs of Finland Mika Lintilä with his delegation. In addition to Minister delegation, Business Finland had invited Finnish companies operating in Vietnam and their local partners to attend the event. The main story of the evening was breaking news from the EU Commission to present EU–Vietnam trade and investment agreements for signature and conclusion. To-be-ratified agreements will substantially strengthen the bind between the EU and Vietnam both in trade and investment maintaining the positive trend which Vietnamese economics and industry have enjoyed recent years. The trade agreement also includes a strong, legally binding commitment to sustainable development, including the respect of human rights, labor rights, environmental protection and the fight against climate change, with an explicit reference to the Paris Agreement.
In discussion with Minister Mika Lintilä (on the right), CEO of Chementors Ltd Jani Määttä emphasized Chementors having a significant role regarding to Vietnam–EU trade. Chementors helps Vietnamese exporting industry to comply with the strict chemical legislation of the EU and thereby secure the smooth export process.
The CLP Regulation (“Classification, Labeling and Packaging”) is based on Regulation No 1272/2008 of the European Union on chemicals, concerning the classification, labelling and packaging of chemicals. The EU Regulations are updated frequently, resulting in costly changes in safety data sheets and labelling maintenance. Poorly timed large label batch orders just prior to a significant update, might cause substantial economic losses.
The eighth technical adaptation (EU) 2016/918 of the CLP Regulation entered into force on 01.02.2018 and includes changes to the classification criteria and the hazard and safety precautions. Therefore, it is important for chemical classifiers to update their data and act according to these changes.
Safety data sheets and product labels in accordance with the CLP Regulation are a significant part of the company’s image and brand. Chementors Ltd. compiles branded high-quality safety data sheets, which serves your company as “business cards”. In addition, when the content of the product label is in compliance with the regulation and matching the safety data sheet, it will have a great impact on your company’s image.
The CLP Regulation was substantially modified also in March 2017, as the Annex VIII (EU) 2017/542 was added. The purpose implementing this annex is to harmonize the information provided to the national poison control centres operating in the EU, to avoid previously appeared problems with identifying mixtures, which caused confusion in patient care. Annex VIII increases the amount of required information, compared to national chemical notifications. The new notification shall also include information on the non-hazardous ingredients, if their content is at least 1%. In addition, the new notification must indicate the type and size of the packaging. European Chemicals Agency is under process of preparing a specific information portal to submit the new notifications. It should be operational by Q1/2019. More information of the portal and its phases can be found here.
The Annex obliges to include the Unique Formula Identifier (UFI) either on the package, or in industrial use, on the Safety Data Sheet. UFI is an ID which enables reliable recognition of the mixture. You can create the UFI code on-line on the website of the European Chemicals Agency: https://ufi.echa.europa.eu/.
Please note that the obligations of the Annex VIII will be implemented in three phases. The obligations of Annex VIII will apply to retail products from 01.01.2020, the obligations take effect on the products for professional uses from 01.01.2021 and the obligations become effective on the products for industrial uses from 01.01.2024. However, should the marketer of the product make the national chemical notification by the deadline, they can benefit of the transition period until 01.01.2025. This requires that the product has not been modified during the transition period.
Chementors Ltd. considers the future changes with their clients already now.
European Chemicals Agency (ECHA) has added ten substances of very high concern (SVHC) to the REACH candidate list. The updated list currently contains 191 substances.
Four of the new candidates – octamethylcyclotetrasiloxane (D4); decamethylcyclopentasiloxane (D5); dodecamethylcyclohexasiloxane (D6); and Bbnzo[ghi]perylene – were added due to their persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) properties. A fifth – terphenyl hydrogenated – has only vPVB properties.
ECHA’s Member State Committee identified siloxanes D4, D5 and D6 as SVHCs last week despite strong criticism from industry. The latter said the committee “had not taken full account of the whole body of scientific evidence” and cited “extremely low” levels in the real environment.
The use of D4 and D5 is already restricted in wash-off personal care products at a concentration equal to or greater than 0.1% by weight.
The agency added three other substances to the candidate list due to their toxic for reproduction properties. These are lead; disodium octaborate; and dicyclohexyl phthalate (DCHP). DCHP is also included in the list due to its endocrine disrupting effects on human health.
The remaining two – ethylenediamine (EDA) and benzene-1,2,4-tricarboxylic acid 1,2 anhydride (trimellitic anhydride) (TMA) – were added due to their respiratory sensitising properties.
The European Commission identified TMA and DCHP as SVHCs in April, following referrals from the MSC.
The Commission said in its implementing Regulation on TMA that the data presented and discussed in the Annex XV dossier show it causes serious and permanent impairment of lung functions if the exposure is prolonged and no intervention takes place. This view is in line with the majority opinion of the MSC.
Sweden made the original proposal to identify DCHP as an SVHC due to its ED properties affecting human health (Article 57(f)), but later withdrew it. Then MSC failed to reach a unanimous agreement on its identification under Article 57(f).
The country also proposed the identification of lead as an SVHC. The metal is forbidden in the EU in small items due to a higher health risk for children from ingestion.
More information of these new entries (their uses in products etc.) can be found here.
Chementors is Your compliant and reliable partner with substance registrations. Read more about our services from here.
The final legal deadline to REACH register all phase-in substances manufactured or imported above one tonne per year was May 31st. If the registration obligation applies and companies did not submit a dossier by the last day of May, as of 1 June they can no longer manufacture or import the substance legally in the EU/EEA.
Chementors helped numerous Finnish and other EU companies, including many SMEs, as well in capacity of our role as legally appointed Only Representative for non-EU manufacturers, successfully submit their registrations for the final REACH deadline. It’s a true milestone and precedent to safeguarding our common future! So congratulations are in order.
We expect companies to finally realise REACH registration being a true business asset with a clear business advantage delivering a return on investment. Companies that registered can have guarantied access to the substances they depend, or your customers rely on, Non-EU companies who registered with Only Representatives will have access to the EU market. Lastly but not least, the added confidence provided now in knowing the relevant risk management measures that ensure safe use. Other positive side effects is that companies worked together sharing costs and avoided animal testing to a minimum. In addition, REACH is to stimulate R&D and innovation to find safer alternative substances and solutions to benefit us all
What will happen after 31 May 2018, as registration is just the first step in sound chemicals management?
There are further obligations to consider under REACH, not just concerning the duty to register. Indeed, registration itself even is not simply a one off task as it is living its dynamic just as are your business and portfolio. You are responsible for the safe use of your chemicals, must maintain compliance with REACH including to keep your registration up-to-date and accordingly implement and/or communicate any safe use recommendations – and this should be really happening and not ignored.
Enforcement is the key! It will really kick-off and becomes more apparent, more strict and more consistent – as it is required to ensure fairness to those complying with the law. Awareness of REACH will continue to grow among managers, workers, retailers, consumers and the public in general. Also other parts of the globe will be following as they are already.
ECHA will be busy checking the quality of the data submitted in the registrations, identifying non-compliant dossiers and also verifying company sizes if they really are an SME. Additionally Member States will also be carrying out substance evaluations to investigate certain concerns and may request even further information beyond the standard requirements. Ultimately further EU regulatory actions may be deemed neccessary.
Registrants and companies in general should be vigilant in order to be forewarned and react in due time. So far a majority of registrations submitted by companies are not adequate in quality, resulting that companies are urged to proactively and voluntarily revise and update the registrations. They are given reminder being responsible and liable of their registrations.
European Chemicals Agency (ECHA) have shared some tips for post-registration actions:
Implement and ensure Risk Management Measures and further information for safe use is followed (capacity as registrant & user or downstream user of chemicals as such in formulations)
Communicate important information – consider if your Safety Data Sheets should be updated OR other measures to informing downstream end users in the supply chain including consumers
Aim to incorporate REACH matters and principles in your own overall day to day business activities and planning, synergising with other in-house management system, or policies
Implement in-house training if necessary and be prepared for any inspections
Make a plan for keeping your registration up to date. Keep track of new data, potential new uses for your substance and volumes produced or imported.
Make sure you have access to your REACH-IT account (login details, set up e-mail notification alerts, back up contact person) – ECHA communicates officially to registrants via REACH-IT.
Have a platform to collaborate with your other co-registrants to deal with new registrants and requests for more information from authorities.
Submit an inquiry for each new substance you place on the market in quantities over one tonne per year.
Follow the authorities’ work: check your portfolio for substances that are subject to regulatory action and see whether safer alternatives are available
Seek help if needed, its available – from national helpdesks, ECHA helpdesk, Guidance documents, YouTube videos, industrial associations, laboratories
ECHA acknowledges the importance of support provided by consultants and specialists since certain tasks are not straightforward, or companies simply don’t have the in-house capabilities or time. ECHA published a checklist helping you to select a suitable and reputable consultant
Chementors can help companies to review and update their registrations with the newest IUCLID format version while offering the benefit from all the experience gathered, as well as ECHA and sector feedback and advice now available. Chementors mentors companies in all roles and in multiple areas to concern chemical and product compliance management. Should you have any doubts or questions, please do get in touch. Our clients trusts us with their business.
Turku Science Park Ltd. arranges SmartCHEM Summit 2018 which presents the latest innovations in bio-based production and solutions for creating new business from side-streams. The event gathers industry, growth companies, experts and academics from Finland and Europe on May 22nd 2018 to the brand new Visitor and Innovation Centre Joki in Turku, Finland.
After the event, IBC Finland organizes a Hackathon together with the BiOpen project, to which all seminar attendees are warmly welcome to discuss sustainable solutions under several theme tables.
In the evening at 7 pm is organized a get-together for SmartCHEM participants at Aboa Vetus Ars Nova (Itäinen Rantakatu 4-6).
The leading global event for personal care ingredients
The exhibition brings together up to 800 international exhibitors of ingredients, fragrances, lab equipment, testing and regulatory solutions with up to 9,000 cosmetic manufacturers worldwide.
in-cosmetics Global is the global launch place for innovation in ingredients and technologies, providing high-level scientific education and consumer insights for formulators, R&D and regulatory professionals.
Showcasing industry trends throughout the world, in-cosmetics Global offers you the opportunity to immerse yourself in the latest innovations, understand new developments in personal care ingredients and network with the world’s personal care ingredients community.
Like last year, Chementors is attending as well, introducing services regarding to EU chemical regulations but also welcomes companies aiming at the Asian markets. Should you prefer to set up a meeting in advance, please contact: firstname.lastname@example.org.