Questions and Answers
Duty holders and validity of information
The duty holders are economic operators (importers and downstream users) based in the European Economic Area, i.e. 28 Members States of the European Union and Norway, Iceland and Lichtenstein. Downstream users and importers placing hazardous mixtures on the market have to submit information according to Annex VIII to the CLP. Other operators that perform activities such as re-packaging, re-filling or toll formulating may also be required to make a submission.
In case of hazardous mixtures supplied from outside of the EU, it is the importer based in the EEA that has the duty to submit. There might be some workaround solutions to protect the CBI of the non-EU supplier, which will be specified in the guidance on implementing Annex VIII. Note also, that Switzerland is considered as non-EU, although their regulations may be similar to the ones applicable in the EU.
No, only in the Member State where you place on the market.
It is still unclear whether and how chemical laws, including this Annex VIII, will be applicable to the UK after its withdrawal from the EU.
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.
You need to submit harmonised information on mixtures you place on the market if they are classified for any health or physical hazard. You do not need to make a submission on substances or mixtures intended only for R&D or PPORD. In addition, you do not need to submit mixtures classified only as gases under pressure or explosives.
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.
It is considered that, in some cases, non-hazardous components may be also harmful if e.g. digested in large amounts or if synergistic effects occur.
The scope of this (currently expressed in the draft guidance) is being under consultation. However, it could, for example, cover a situation where the notification is accepted from a technical point of view (e.g. all fields are filled in), but a follow up is necessary to verify the meaningfulness of the information.
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. Note that mixtures which are subject to supplemental labelling requirements according to Part 1 and 2 of Annex II to CLP (e.g. EUH208) but are not themselves classified for health or physical hazards, are not subject to submission requirements and do not need a UFI.
While performing a quality check of the submitted information, Member States’ Appointed bodies may contact the submitter directly to request clarification for any deficient, unclear or conflicting information. The request must, however, be reasonable and necessary for the Appointed body to carry out its tasks under Article 45 of the CLP.
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 and should not generate disproportionate costs to the Member State.
Previous submissions and transition period
The transition period will last from 2020 until January 1 2025.
No. Once you are required to comply with Annex VIII, then you will have to include the UFI on the label.
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 PCN Portal, but Member States can exchange views on this topic in the context of the IT user group.
For the new submissions, ECHA will provide the hosting of the data. This would still require Member States to take care of their "old" database until 2025.
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 information 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.
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 submission 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.
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 should ideally be accompanied with the submission of information.
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), section 15.
In this situation, it is sufficient to put the UFI in the safety data sheet (SDS), in section 15.
According to the current interpretation, the UFI must always be on the label. Please recheck the Guidance once it is finalised.
¬The rules concerning the UFI on the label require it to be clearly visible, legible, and indelibly marked i.e. it can't wash off. Printing techniques need to meet this expectation.¬
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 submit 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.
Individual companies have distinct VAT numbers, therefore the duplication of UFIs is not possible. However, UFIs for subsidiaries must be carefully managed by the parent to avoid the generation of duplicates. For example the parent company can generate and distribute UFIs for the subsidiaries using one central VAT number.¬
Given that the VAT number is generally not confidential, it is recommended that companies use their own VAT number to generate their UFIs. However, a ‘company key’ is available for use by companies that do not have a VAT number or in case of confidentiality issues
Yes, the same UFI can be used as long as the composition remains the same.
The UFI is required to be printed on or affixed to the label of hazardous mixtures in accordance with Annex VIII, and included in the submission of information. Note that there are derogations for UFI labelling e.g. in the case of industrial mixtures or mixtures not packaged, where it is sufficient to include the UFI only in the SDS.
A 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 composition 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.
All hazardous mixtures within a multi-component product must have their own UFI displayed on the label.
CLP labelling is normally required on every layer of a packaging intended for supply and use. Further details on the considerations and exemptions from the labelling and packaging requirements are covered in the Guidance on labelling and packaging.
You may consider submitting information on 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 upfront, not on the assumption that ‘if it is not notified, it is not hazardous’.
In any case, putting the UFI on the label of non-hazardous mixtures voluntarily notified will also remain voluntary.
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’.
MiM – Mixture in mixture
A mixture placed on the market often consists of a mixture in mixture – in other words it is made by mixing two or more mixtures together according to the formulator’s specifications.
If you know all the components of the MiM, you need to list them like you would the other components of your mixture. If you do not know all the components of the MiM, you need to ask your supplier for the UFI of the MiM.
Yes, when the UFI of the MiM has changed it may imply that the composition of the MiM has changed and therefore it may require an update also on your final mixture.
You can either request the compositional information from your supplier, or if they have made a voluntary submission, they can also provide you with a UFI instead. In any case, you should have some information on the composition, e.g. the name of the main component and its CAS number.
When submitting information on a mixture, the duty holder must comply with the submission deadline according to the end use type of their ‘original’ mixture. That is, if a mixture originally formulated for industrial use ends up in a ‘final mixture’ intended for consumer or professional use, the duty holder should make their submission according to the requirements (and applicable deadline) set for consumer or professional use.
PCN portal and storage of submissions
Annex VIII to CLP has unified the information requirements and defined the harmonised format for the submission of information. Further to this, the possibility to centralise the submission process was explored by a feasibility study. Benefits included economies of scale, improved efficiency of industry and ensuring a high level of security.
Several Member States and industry representatives have expressed their preference for establishing a centralised submission and dispatch system. The extent to which ECHA will be in a position to develop such a centralised submission and dispatch portal will be made clear as soon as the final decisions have been made by the Commission and the REACH Committee in the course of 2018. However, despite such a system being developed by ECHA, Member States may still develop or adapt their own national submission systems. Since the format and requirements for the submissions have been harmonised across the EU, any submission system (centralised or national) must ensure that it complies with these legal requirements.
This depends on ECHA and the Member State appointed bodies’ IT readiness to receive and process submissions in the new system. The process of submitting and dispatching could possibly start from 2019, however, it will only be mandatory from 1 January 2020.
For Member States that opt for developing their local submission systems, they must be available to receive submissions by the relevant deadlines. Contact relevant Member States with regard to this information.
The ECHA centralised submission and dispatch portal, the Poison Centres Notification (PCN) portal is expected to be available as version 1 in early 2019; Version 2 offering more features beyond the submit and dispatch function is expected in Q3/2019, before the first applicable deadline.
The submitted information in the Poison Centres Notification (PCN) Portal will be dispatched to Member States’ Appointed Bodies and they will in turn make this information available to the national 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.
Yes it is technically possible. Regarding the mandate and resources for ECHA to offer this service, this is expected to be clarified later in 2018.
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.
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. The compliance with the standard security requirements (SSR) will be controlled by mandatory reporting and audits reviewed by ECHA.
Upon further agreement, the statistical information gathered on incidents could be shared to identify potential needs for preventative measures.
The IT tools that support the submission process cannot check the quality or adequacy of the submitted information. The validation of the technical completeness of the data is, however, possible and this feature may be added to the portal upon agreement with Member States. A dedicated working group facilitated by ECHA is expected to be kicked-off in Q3 2018.
Regardless of the support offered by ECHA’s automated validation, it is not expected to fully replace the manual verification performed by Member States, therefore validating the quality or adequacy of the information submitted will remain at national level.
Yes, as long as security standards are ensured. The details are however still under consideration by the IT Tools User Group and PCN development team.
Even after a centralised submission and dispatch system along with database hosting will be in place, Member States may decide to 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.
Language requirements and multilingualism
Submissions must be in the national language required by the Member State, however, other languages e.g. English may be considered according to the Member state’s own discretion.
Indeed, a submission must be made 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.
This means that the free text fields must be filled in the national language of the Member State. According to industry wishes, multilingualism will be supported by the PCN Portal using picklists in a structured format.
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 make a submission 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.
It will remain at the discretion of the Member States whether to charge fees for the submission of information. The financial transactions are expected to continue being settled between submitters and the relevant national appointed body.
The submission format and support tools are made available free of charge. ECHA does not foresee additional fees for hosting the PCN Portal for the submission of information.
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 by the IT User Group. The Security Officers Network will be involved in establishing a security model for the PCN portal.