Questions and Answers
IT tools supporting the preparation of notifications:
- The UFI generator is already available in its final version on ECHA’s Poison Centres website;
- The poison centres notification (PCN) format and editor will be available in early 2018. The version currently available on ECHA’s Poison Centres website is a draft
IT tools supporting the submission of notifications:
- If the ECHA centralised notification and dispatch portal is the preferred outcome of the feasibility study, it is expected to be available in early 2019;
- If Member States opt for developing their own submission systems, the timelines must be provided by them when the outcome of the ECHA feasibility study is known. Notification systems must be available to receive submissions by the relevant deadlines.
- Guidance will be adopted by the end of 2018. Draft versions will be made available before;
- Manuals will be provided when the IT tools are launched.
This depends on ECHA and the Member State appointed bodies’ IT readiness to receive and process notifications in the new system. The process of notifying and dispatching could possibly start from 2019, however, it will only be mandatory from 1 January 2020.
The EU product categorisation system (PCS) will be finalised in 2017, together with the accompanying practical manual and a procedure for future updates and maintenance of the system. Stability of the system will be looked at by the dedicated focus group on EU PCS.
Support and cooperation with stakeholders
Altogether, three working groups have been called by ECHA to gather contributions from Member State appointed bodies, poison centres, industry associations, public bodies and individual stakeholders.
They will cover:
- the finalisation of IT tools to be used for notification purposes including input to the feasibility study on a central notification system;
- the conclusion of the EU product categorisation system; and
- the development of Guidance and support.
These groups will work from April 2017 until the end of 2018, depending on the topic.
The list of stakeholders participating in the working groups is published on ECHA’s Poison Centres website. Information on the work of these groups will be provided through ECHA’s communication channels and the Poison Centres website.
User manuals for the use of IT tools hosted by ECHA and the product categorisation system (PCS) and guidance documents on the interpretation and application of the new regulation will be made available.
Documents and information will be available on ECHA's Poison Centres website by the end of 2017. Guidance documents may be ready in 2018 and will be published on the Guidance section of ECHA’s website.
Additional training material and webinars will be designed and developed according to identified needs.
Feedback on legislation
The European Commission will launch a workability study in relation to certain industries with complex inputs and supply chains e.g. the petroleum and construction products industry. Discussions on particular provisions for other sectors are envisaged if a significant workability issue is identified.
The Commission considers it relevant to assess any issues now, which were not assessed during the drafting stages.
The issue of definitions for consumer, professional and industrial uses will be reviewed and addressed by the guidance working group. Additionally, the European Commission will adopt a position on this matter taking into account the input and comments received from stakeholders.
The draft PCN editor and format was established before the publication of the amended legal text. In the process of updating the draft PCN format and editor to their final version, the changes will correctly reflect the legal text in addition to all the feedback collected. Some of these features will include, but are not limited to, group submission, selection of multiple P-phrases, and a product category. Also, it is anticipated that the PCN editor will be made available in all EU languages in early 2018.
Poison Centres Notification portal and storage of notifications
Several Member States and industry representatives have expressed their preference for establishing a centralised submission and dispatch system. ECHA initiated a feasibility study on this beginning in April 2017 and the outcome is expected to be communicated in October 2017. The extent to which ECHA may be in a position to develop such a centralised submission and dispatch portal will be made clear. However, even if a centralised submission and dispatch system is proposed, Member States may opt-out and develop their own national submission systems. Since the format and requirements for the notifications have been harmonised across the EU, any submission system (centralised or national) must ensure that it complies with these legal requirements.
In 2017, both ECHA and the Member States need to clarify a number of aspects, while in 2018 all the technical developments should be performed to ensure that the submission systems are ready for use in 2019.
The feasibility study will provide a clear vision of the needs and possibilities of a PCN portal at ECHA - the outcome of the study is expected to be communicated in October 2017.
ECHA also established an IT user group in April 2017 of various stakeholders to support the work of the feasibility study. This group reviews and assesses functional and non-functional requirements signalled by Member States and other stakeholders to be supported by the PCN portal and prioritises IT solutions. You can find the list of stakeholders participating in the group on ECHA’s Poison Centres website.
The IT tools that support the notification process cannot check the quality or adequacy of the submitted information. The validation of the technical completeness of the data is, however, possible and will be investigated during the feasibility study, including the extent to which it can be supported through IT tools when preparing the notification and at the moment of its submission.
Validating the quality or adequacy of the information submitted will remain at national level, at the moment, due to the resource implications and multilingual requirements. However, if a centralised submission system is indicated as the preferred outcome of the feasibility study, how the technical completeness validation by ECHA could be improved so that it can contribute to the overall increase of quality needs to be investigated. Regardless of the support offered by ECHA’s automated validation, it is not expected to fully replace the manual verification performed by Member States.
Depending on the outcome of the feasibility study, ECHA may be able to develop a centralised submission and dispatch portal. However, even if a centralised submission and dispatch system is proposed, Member State appointed bodies may opt-out and develop their own national submission systems.
According to the CLP Regulation, the appointed bodies are responsible for receiving the notifications and making the information available to the poison centres.
If an appointed body wants ECHA to dispatch information directly to the national poison centre, a trilateral agreement between ECHA, the appointed body and the poison centres would need to be established.
The development of the central notification portal will focus on aspects related to the notifications of hazardous mixtures within the scope of Article 45 of the CLP Regulation. Any other requirement (e.g. information on non-hazardous mixtures) is not given a priority and is not likely to be developed in the first version of the portal.
The update mechanism is quite complex and can be seen from different aspects (e.g. legal entity, composition, contact details, payments, databases, etc.).
Updates may be voluntary or requested by Member State appointed bodies, thus a communication aspect is also important. All these issues will be looked at by the dedicated IT user group and guidance working group.
Two approaches require further analysis: either ECHA hosts a database on behalf of a Member State or ECHA supports a Member State to develop their own database solution. ECHA included this aspect into the feasibility study and the outcome will indicate the extent to which the Agency may be able to support Member States regarding the database solution.
Member States are invited to express their preferences and expectations in the context of the feasibility study. As soon as the outcome of this feasibility study is known, Member States will need to decide.
A secure transfer of information will need to be ensured between the notification portal and the national databases. Possible delivery or query methods will be defined and agreed between ECHA and the Member States according to security standards (e.g. file transfer protocol (FTP), web service, email).
A database developed by a Member State needs to ensure the same standards in terms of minimum user support, search criteria or necessary security standards. Member States interested in developing their own database solution can provide ECHA with input on their needs, so that they can also be assessed during the feasibility study.
Any database of notifications (hosted by ECHA or Member States) will contain highly sensitive and confidential information. Access to this information has to be granted exclusively to the authorised persons that need this information for emergency health response purposes. This is part of the security standards that will be defined during the feasibility study.
Upon further agreement, the statistical information gathered on incidents could be shared to identify potential needs for preventative measures.
Yes, as long as security standards are ensured. This aspect of database use is however beyond the scope of the submission and dispatch system subject to the feasibility study.
Even if a centralised submission and dispatch system along with database hosting would be proposed, Member States may opt-out and receive the notifications using their own systems that collect information in their preferred way, as long as it is possible for industry to fulfil their legal obligations.
It is considered that, in some cases, non-hazardous components may be also harmful if e.g. digested in large amounts.
National systems remain in place until 2020. It is at the discretion of a Member State to allow the submission of information in a new format before that deadline.
The scope of this is being discussed in the guidance working group. However, it could, for example, cover a situation where the notification is accepted from a technical point of view (e.g. all fields filled in), but a follow up is necessary to verify the meaningfulness of the information.
You may consider notifying non-hazardous mixtures for various reasons:
- Your mixture ends up as a mixture in a mixture (MiM) in your customer formulation and you do not want to disclose its composition. Instead you can provide a UFI.
- There might be incidents with your product and you would prefer poison centres to know about its harmlessness of it upfront, not on the assumption that ‘if it is not notified, it is not hazardous’.
- You may wish to track your mixtures or perform statistical analysis on them.
In any case, putting the UFI on the label of non-hazardous mixtures voluntarily notified will also remain voluntary.
Generic components such as perfumes, fragrances and colouring agents do not need to be detailed in a mixture composition, if they are not classified for any health hazards and their concentrations do not exceed 5 % for the sum of perfumes and fragrances and 25% for the sum of colouring agents.
It can be difficult to obtain information on the composition of a mixture from a non-EU supplier. However, under both CLP and REACH, importers need to know which substances are present in the mixtures being imported to be sure they are complying with the law. It is up to companies to improve the communication through their supply chain to ensure their compliance with CLP and REACH. It may be helpful to tell suppliers why the information is needed, which may be unknown, particularly to non-EU suppliers.
The trigger for notification duty is harmonised at EU level and refers to mixtures classified for physical and human health hazards.
Unique Formula Identifier (UFI) and labelling
The UFI does not have any expiration date and products can keep their UFIs, as long as the corresponding notification submitted to the relevant appointed body remains valid. Whenever a product changes to such an extent that a new UFI is required, the UFI on the product label will also have to be changed.
The UFI Generator and the developers’ manual available on ECHA’s website are final. Companies can start generating their UFIs and perform internal preparations such as the mapping with internal formulation codes. Placing the UFI on the product label before 1 January 2020 is not mandatory, but is possible.
The published version of the UFI Generator is final. Creating a mapping of companies' internal formulation codes into formulation numbers between 0 and 268 435 455 is an essential preparatory step to be performed by companies to generate the UFIs.
This IT solution has been found to be the most feasible option. As the UFI algorithm is public, this process can be simplified by embedding the mapping and UFI generation within a single system (under the control of the company developing their own generator).
Yes, a company can generate separate UFIs for the same mixture.
A company can manage their VAT numbers and internal formulation codes with the aim of ensuring the correct mapping and tracking of multiple UFIs.
You can put the UFI on the label of mixtures for industrial use, however, it is sufficient to only put the UFI in the safety data sheet (SDS).
No, the UFI must always be on the label.
You do not need to relabel your mixtures if they were notified under national schemes as the notification remains valid until 1 January 2025, unless you need to make an update. When you notify according to Annex VIII, you are required to relabel your mixtures with the UFI code.
The VAT number is only a means to generate UFIs. After the UFI is generated, it is no longer linked to a specific company. The IT tools user group is looking at the legal entity change aspect for the IT development.
Including the UFI on the label of non-hazardous mixtures will remain voluntary, however, you may wish to do so as there might be incidents with your product and you may prefer poison centres to know about its harmlessness upfront, not on the assumption that ‘if not notified, not hazardous’.
Yes, the same UFI can be used as long as the composition remains the same.
The UFI is required for hazardous mixtures which require a notification. While it is not mandatory to place the UFI on the label for voluntary submissions, doing so may be useful for poison centres or for statistical analysis of your products.
The UFI is always required for hazardous mixtures regardless of whether they are intended for consumer, professional or industrial uses.
The UFI is linked to a mixture rather than a product, which means that if a product has different trade names (but all having the same composition) only one UFI is required. However, you may wish to generate separate UFIs for the same mixture marketed with e.g. different trade names.
Duty holders and deadlines
Downstream users and importers placing hazardous mixtures on the market have to notify. Other operators that perform activities such as re-branding or re-packaging may also be required to notify.
You need to notify mixtures you place on the market if they are classified for any health or physical hazard. You do not need to notify substances or mixtures intended only for R&D or PPORD. In addition, you do not need to notify mixtures classified only as gases under pressure or explosives.
This depends on ECHA and the Member State appointed bodies’ IT readiness to receive and process notifications in the new system. The process of notifying and dispatching could possibly start from 2019, however it will only be mandatory from 1 January 2020.
You are obliged to notify to national systems until 2020 unless the new system is in place and your national authorities allow its use.
The notification already submitted will remain valid until 1 January 2025 unless you make any change which requires an update according to Part B of Annex VIII. In that case, you are required to comply with Annex VIII before placing the mixture as modified on the market.
There is no “expiration date” and the information is expected to remain in the system even after the product is no longer placed on the market.
The information must always be up to date for mixtures as long as they are placed on the market. If the product is no longer placed on the market, the company is not required to update the information.
Language requirements and multilinguilism
Notifications must be in the national language required by the Member State, however, other languages e.g. English may be considered.
Indeed, notifications have to be submitted in the language of the Member State where the product is placed on the market, unless that Member State allows a different language to be used.
ECHA has launched a feasibility study in April 2017 to investigate the possibility of developing a central notification portal (PCN portal) and the possible level of support to multilingualism for industry and Member States offered by the PCN portal will be looked at during this feasibility study and discussed by the IT user group.
The possibility for industry to prepare the information in their preferred language and have it "translated automatically" to be able to submit it in a language allowed by the Member State will be investigated.
In principle, you need to submit a notification to every Member State where you place on the market in the language of that Member State. How this will be done in practice depends on the final agreed structure of the IT system.
The phone service needs to always be available. The service is expected to be in the languages of the Member State where the mixture is placed on the market.
Confidentiality of information and security aspects
The information will only be made available to appointed bodies and the poison centres only receive the information, which is relevant for performing their tasks.
You can avoid disclosing the composition of your mixture to your customer by providing the UFI. Your downstream users will include that UFI in the notification of their products.
Security is one of the most important aspects of the system and it is considered in the feasibility study. The Security Officers Network will be involved in establishing a security model for the PCN portal.
The transition period will last from 2020 until January 1 2025.
Two databases (one with the existing notifications and one with the new notifications) can co-exist until 2025. The decision to migrate (incorporate existing data to the new database) is at the discretion of Member States.
The migration of data is beyond the scope of the submission and dispatch system subject to the feasibility study, but Member States can exchange views on this topic in the context of the IT user group.
For the new notifications, Member States can consider using the solution where ECHA provides the hosting of the data (subject to the outcome of the feasibility study). This would still require Member States to take care of their "old" database until 2025.
No. Once you are required to comply with Annex VIII, then you will have to include the UFI on the label.
It will remain at the discretion of the Member States whether to charge fees for notifications. The financial transactions are expected to continue being settled between notifiers and the relevant national appointed body.