Questions and Answers
Concerning the availability of the IT tools supporting the preparation of notifications:
- The UFI generator is already available in its final version on ECHA’s Poison Centres website;
- The PCN format and editor will be available early 2018. The version currently available on ECHA’s Poison Centres website is draft version
Concerning the availability of the IT tools supporting the submission of notifications:
- Should the ECHA centralised notification and dispatch portal be the preferred outcome of the feasibility study, it is expected to be available in early 2019;
- Should Member States opt for developing their own submission systems, the timelines must be provided by them as soon as the outcome of the ECHA feasibility study will be known. Notification systems must be available to receive submissions by the relevant deadlines.
Concerning the availability of the support material:
- Guidance shall be adopted by the end of 2018. Draft versions will be made available before;
- Manuals will be provided at the time of the launching of the corresponding IT tools (see above).
It depends on ECHA and Member States appointed bodies readiness to receive and process notifications in the new system. The process of notifying and dispatch could possibly start from 2019, however it will be mandatory only as of 1 January 2020.
The EU PCS will be finalised in 2017, together with accompanying guidance 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 co-operation with stakeholders
Altogether, three working groups have been called by ECHA to gather contributions from Member States appointed bodies and poison centres, industry associations, public bodies and individual stakeholders. They will cover the following topics: the finalisation of IT tools to be used for notification purposes including the 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 to the working groups is published on ECHA’s Poison Centres website.
Information on the work of these groups will be provided via ECHA’s communication channels and the dedicated ECHA Poison centres’ website.
The Commission's Structural Reform Support Service (SRSS) offers support to Member States among others for the implementation of EU legislation. Support may take various forms, from e.g. twinning with other Member States to IT technical support. Support under the SRSS needs to be requested by the Member State to the Commission and requires justification. For more information on the application process, please contact
grow-D2 (at) ec.europa.eu.
Supporting material will be made available in the form of user manuals for the IT tools hosted by ECHA and guidance documents on the interpretation and application of the new Regulation. Documents will be made available on ECHA's Poison Centres website starting by the end of 2017. Guidance documents may be ready in 2018.
Additional training material will be designed and developed according to identified needs. ECHA welcomes Member States and industry needs and will consider them when developing the material.
Poison Centres Notification portal
Several Member States and industry representatives have expressed their preference for the establishment of a centralised submission and dispatch system. ECHA will conduct a feasibility study on that matter during April-July 2017 to investigate this option. The outcome of this feasibility study shall indicate to which extent ECHA may be in a position to develop such a centralised submission and dispatch portal. However, even if a centralised submission and dispatch system would be 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 (be it centralised or national) must ensure that it complies with this legal requirements. In 2017 both ECHA and Member States need to clarify a number of aspects, while in 2018 all the technical developments should be performed to ensure that in 2019 the submission system(s) are ready for use.
The feasibility study should provide a clear vision of the needs and possibilities of a PCN portal at ECHA. ECHA has established an IT user group comprised of various stakeholders to support 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. The feasibility study and IT user groups have started in April 2017 and will continue until the end of 2017. The outcome of the feasibility study is expected to be ready by July 2017. You can find the list of stakeholders participating to the group on the ECHA 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 to which extent it can be supported via IT tools when preparing the notification and at the moment of its submission.
Validating the quality or adequacy of the information submitted will at the moment remain at national level due to its resource implications and multilingualism requirements. However, if a centralised submission system would be indicated as the preferred outcome of the feasibility study, it needs to be investigated how the technical completeness validation by ECHA could be improved to the extent that it can contribute to the overall increase of quality. 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 feasibility study, ECHA may be in position to develop a centralised submission and dispatch portal. However, even if a centralised submission and dispatch system would be proposed, Member States appointed bodies may opt-out and develop their own national submission systems. According to the CLP Regulation, the appointed bodies are responsible to receive the notifications and make the information available to the poison centres. Should an appointed body wish 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 that are within the scope of Art. 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. Nevertheless, additional requirements flagged by Member States will be looked at during the feasibility study.
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 outcome of the feasibility study). This would still require Member States to take care of their "old" database until 2025.
This requires further analysis by the feasibility study.
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.
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 States appointed bodies, thus a communication aspect is also of importance. All these issues will be looked at by the dedicated IT user group and guidance working group.
Unique Formula Identifier (UFI)
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 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 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).
It is possible to generate multiple UFIs for the same mixture as long as all the UFIs are notified and linked to the relevant notification. A company can manage their VAT numbers and internal formulation codes with the aim to ensure the correct mapping and tracking of the multiple UFIs.
Poison Centres Notification format and editor
The PCN editor will be made available in all EU languages by the end of 2018.
Indeed, notifications shall be submitted in the language(s) of the Member State(s) 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). 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.
The PCN format and editor published on ECHA website are draft tools, not final. When updating the PCN format and editor into their final version during 2017 all the feedback will be taken into account, including this issue of multiple P-phrases.
Storage of notifications
Two approaches require further analysis: either ECHA hosts a database on behalf of a Member State or ECHA supports a Member State in development of their own database solution. ECHA will include this aspect into the feasibility study and the outcome of this feasibility study shall indicate to which extent ECHA may be in a position 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 take decisions.
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. 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 be also 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 shall 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 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 State 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.
Feedback on legislation
The European Commission has launched a workability study as a response to the workability concerns raised by some particular sectors i.e. 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 use 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.