Tag: CLP

May 10, 2021

Potential changes to REACH and CLP-regulations – Provide your feedback!

The European Commission has published two of its Inception Impact Assessments on potential changes to the REACH and CLP-regulations within the scope of the EU Chemicals Strategy for Sustainability. You can find these Inception Impact Assessments and provide your feedback on them by the first of June 2021 by following the links below.

Have your say and affect the changes!

As examples the following are considered by the Commission:

Increasing information requirements on hazards, safe use, and environmental footprint (REACH)
Registration of certain polymers (REACH)
Introduction of electronic safety data sheets to improve information flow (REACH)
Integrating the REACH authorization and restriction systems into one (REACH)
Introducing new hazard classes e.g. endocrine disruptions (CLP)
Clarifying classification obligations for mixtures and some complex substances (CLP)

You can comment the Inception Impact Assessments from the links below.

SCIP database launched for tracking chemicals of concern in products

European Chemicals Agency (ECHA) has launched the SCIP database for tracking chemicals of concern in products. Information on substances of very high concern can be now submitted to the database. In order to improve safe recycling of waste and enhance circular economy, companies are required to report hazardous chemicals in their products to the database. More knowledge on chemicals in products is also needed for making the EU Green Deal work. Moreover, improved data also protects workers, citizens and the environment and encourages companies and industry to replace their potentially hazardous chemicals with safer ones.

The Waste Framework Directive requires companies to submit their chemical data to the database as of 5^th of January 2021. Consumers and waste operators will have access to the database in February 2021 onwards. The database has been developed in cooperation with stakeholders and an IT user group. Based on industry feedback, the database is built to simplify the companies’ work. For example, a system-to-system submission function helps companies submit notifications easily. Also, companies can work together by referring to data that has already been submitted when adding new notifications to the database.

There is supportive information about the SCIP database on ECHA’s website. What is more, there will be a webinar about the tools and features included in the system on 19^th of November.

Does your company need help with SCIP requirements? Ecobio’s experts are happy to help! Please contact us and ask about our services.

info@ecobio.fi

Text: Ecobio Oy

Picture: Shutterstock

References: https://echa.europa.eu/fi/-/tracking-chemicals-of-concern-in-products-scip-database-ready-for-use

March 17, 2020

Important Brexit deadlines for importers and users of chemicals

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

Chemical Watch summarises the key dates of Brexit as follows:

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

What does this mean for companies?

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

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

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

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

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

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

Helena Niemelä

Senior Consultant, Ecobio Oy

helena.niemela@ecobio.f

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

April 24, 2019

The 12th adaptation to technical progress of the CLP

CLP regulation change (EU) 2019/521

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

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

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

Ecobio will gladly answer any questions regarding CLP regulation, chemical legislation or chemical management!

Contact our experts at: info@ecobio.fi or tel. +358 20 756 9450.

Text: Ecobio

Picture: Aivan

June 20, 2018

Blog: REACH – ripple effects on the whole supply chain

An important milestone for the European chemical industry has been reached as the final REACH registration deadline for substances passed in 31.5.2018. The European REACH Regulation ((EC) No 1907/2006), however, continues to set high standards for the whole industry, from manufacturers, importers, formulators and distributors all the way down to downstream and end users.

Effects on the supply chain

Whilst the REACH registration deadline passed in 31.5.2018 already, it can take up to 3 months for the European Chemicals Agency ECHA to make a registration decision; your supplier might be fully REACH compliant if they have submitted their dossier on time, but might not yet have received a registration decision, i.e. a registration number, from ECHA. In complex cases where an extension might have been received from ECHA and the Director’s Contact Group, receiving a registration decision will take even longer than that.

This also means that the potential effects of the last registration deadline that mainly dealt with SMEs and their substances might affect supply chains with a delay. Whether or not the registering company had enough assets and know-how to pull through the registration might become evident only later on. If a company has decided to cease their manufacture by 31.5.2018, they are still allowed to sell all their supply gathered before the deadline to downstream users as distributors. Whether or not some companies or some products might be dropping out, or the market become more homogenized, will most likely be found out only after the dust of the final registration deadline has settled.

Communicating REACH compliance to authorities and stakeholders

In terms of supply chains and their continuance, it is important to notice that pre-registration numbers are no longer valid. It is also important to notice that either a generic or a company-specific version of the actual REACH Registration number can be put forward. The company-specific version always consists of four parts of numbers, e.g. 01-2119458769-17-0003, whereas the generic form might only consist of three (e.g. 01-2119458769-17 or 01-2119458769-17-XXXX). Make sure that your suppliers have actually registered the substance in their name, and are not just giving you a generic number to keep you content for a while.

A good way to communicate a company’s adherence to REACH and its many requirements is a REACH declaration of compliance. Such a statement can serve as a testimony to the authorities or as communication to customers and other stakeholders to show that your company is indeed REACH compliant in all the relevant aspects of the REACH Regulation. Such a statement is a hard asset outside of Europe as well.

A shift in focus towards formulators

As the burden of REACH has previously been mainly on substance manufacturers and EU importers, the focus of the regulation is now shifting towards formulators. The safe use of mixtures is a topic that will need to be addressed by operators in the coming years in the form of unique formula identifiers (UFI) and poison centre notifications (PCN). This will require a thorough knowledge of the composition and hazardous properties of the supplied mixtures as well. Exposure scenarios and their utilization in communicating the safe use of mixtures will surely be giving formulators some gray hair.

Increasing amount of regulation

As ECHA is now the holder of the world’s largest open database of substance information, plans on how to best utilize the gathered information on the registered substances are big. On a general level this might mean more substance restrictions and harmonized classifications. Manufacturers of highly hazardous substances or those who have submitted incomplete information, on the other hand, might become a target for even more scrutiny.

Reaching the legislative deadline will also most definitely result in increased supervision from national authorities on whether or not companies have fulfilled their various requirements under the REACH Regulation, with regard to substance restrictions and registrations especially. A more scrutinized assessment of SDS’s and of the responsibilities that downstream users have regarding exposure scenarios and their assessment against their own conditions could also result.

Harmonized classifications under the CLP Regulation ((EC) No 1272/2008) themselves can also be a source of restriction, as is now happening with titanium dioxide. A common chemical used as a pigment and thickener in a wide variety of applications for consumer use, including foodstuff, is about to receive a category 2 carcinogen classification, meaning heavy restrictions on its use in many of its current applications.

Competitive edge for European companies

One of the main original aims and visions of the comprehensive chemical legislation that is REACH is to ensure a high level of health and environmental protection. Another aim of the regulation has been to stimulate innovation and enhance the competitiveness of European brands on international markets. As chemical legislation is getting stricter all around the globe, REACH is indeed serving as an important example for other countries striving for increased chemical safety. This is one of the reasons why being REACH compliant is an asset all over the world; still today, REACH is the most advanced chemical legislation in the world.

Consumer image – a threat or a possibility?

An increasing amount of portals and sources for consumers on how to use chemicals safely and on how to find relevant safety information on chemicals have also emerged. Whilst a huge amount of scientifically-based information on chemicals and their safe use is now publicly available, what should never be underestimated is the opinion and views of the general public. Companies should therefore have an understanding of what the data gathered by them actually means and how it can be translated into facts and to transparent stakeholder communication.

Registration in the future

Now that all the three major deadlines for the REACH registration of chemicals in different tonnage bands have passed, the registration of future substances will require more planning in advance; as of now substances will need to be registered before manufactured or imported into the EU in amounts above 1 tonne per year. Make sure to make use of all the relevant exemptions to registration requirements. For R&D substances, for example, a PPORD notification will give your company a 5-year period of reflection before deciding on whether to continue with the substance or not. For substances produced in circular economy processes, further exemptions also apply.

For more of the concrete results that REACH keeps delivering, see the press release of the European Commission on the matter: http://europa.eu/rapid/press-release_IP-18-1362_en.htm

Leea Ojala, Senior consultant

20.6.2018, Helsinki

In case you have any questions about your obligations under the REACH Regulation or are interested in a REACH Declaration of Compliance or a screening of substance restrictions on your chemicals, contact Ecobio’s experts at: info@ecobio.fi or tel. +358 20 756 9450.

Read more about our services related to REACH!