Küsimused ja vastused
Küsimused ja vastused – sissejuhatus
Questions and Answers
Article 45 places direct submission obligations to importers and downstream users based in the European Economic Area, i.e. Members States of the European Union and Norway, Iceland and Liechtenstein. These operators, when placing hazardous mixtures on the market, have to submit information according to Annex VIII to the CLP to the relevant appointed body. Nevertheless, all operators in the supply chain have the obligation to make sure they place on the market mixtures which are in compliance with CLP as a whole , as stated in article 4(10). This means that distributors (in particular rebranders/relabellers or companies distributing a mixture in another Member State) may need to submit themselves if the relevant information is not included in a submission made by the supplier.
Please note that the interpretation of the role of certain operators (namely re-branders) has not been agreed among all Member States Competent Authorities. We recommend you to refer to the Guidance on Annex VIII where detailed information is available.
Yes. The imported mixture may be used at the first place of import by the importer themselves, or may be imported in Member State A and subsequently placed on the market also in Member State B. Since import is deemed to be “placing on the market”, a submission is required in both member States A and B.
Companies based in the UK have the same obligations as any other EU/EEA company during the transition period until 31 December 2020 provided by the Withdrawal Agreement. 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. Please, refer to the dedicated section of the ECHA website on the UK withdrawal from the EU where up to date information are available.
You need to submit information on mixtures classified for any health or physical hazard and falling under the scope of the CLP Regulation. Therefore the obligations do not apply to substances. You also do not need to make a submission for mixtures intended only for R&D or PPORD. In addition, you do not need to submit information on mixtures classified only as gases under pressure or explosives. Certain mixtures which are exempted by CLP as a whole (e.g. certain mixtures in the finished state intended for certain uses for which specific legal provisions exist), do not need to be notified even if hazardous. However, if such mixtures have additional use types, obligations under CLP Annex VIII may apply, as for example with food flavourings used in e-cigarettes. In some cases, mixtures may be combined with an article in a way that the article acts as the carrier of a mixture, e.g. scented candles or cleaning wipes. Please consult the Guidance on Substances in Articles for details.
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.
Yes, substances in solutions are in the scope of Article 45 of the CLP Regulation. By definition, a solution composed of two or more substances is a mixture, see CLP Article 2(8). This includes certain diluted acids and bases which may be listed with the notation "%" in Annex VI to CLP. Note that such entries are treated as substances for the purposes of a C&L notifications and should also be notified as such to the C&L Inventory under the conditions of CLP Article 39(b) when they are placed on the market.
In some cases, the requirements introduced by CLP Annex VIII may partially overlap with other existing EU legislation. In such cases, the duty holder needs to comply with both regulations, such as with the Biocidal Products Regulation (BPR) and the Plant Protection Products Regulation (PPPR), which require duty holders to provide full information on the identification, chemical composition and hazards of the mixture.
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.
Note that is no “expiration date” of a notification and the information is expected to remain in the system even after the product is no longer placed on the market.
All hazardous mixtures within a multi-component product require their own notification and UFI. As a general rule, the UFIs of all the mixtures which are part of the final product should appear on the label or packaging. In each notification, the submitter may indicate in the free text field that the mixture is part of a multi-component product.
What are the workability solutions included in the second amendment to Annex VIII?
The second amendment provides solutions on the workability issues raised by industry following the publication of the original version of Annex VIII. These issues were:
- mixture composition variation due to multiple suppliers of very similar (but not exactly the same) components,
- variation of component compositions out of allowed ranges due to raw material of natural origin, and
- point of sale paints which are formulated on demand at point of sale.
The ICG solution may help you if you are unable to determine the exact mixture composition at each point in time (because of an unforeseeable change in components), but with no changes with regard to classification, hazard or emergency health response.
This can happen when a component which is toxicologically similar but not exactly the same, is purchased from different suppliers. If the components meet the specific criteria defined in the amended Annex VIII, they can be grouped in an ICG. The concentration can be provided for the group instead of each component.
You can find the exact requirements to benefit from the interchangeable component group (ICG) solution in Annex VIII (Section 3.5 of Part B). There are two sets of conditions:
- For all the components in the ICG:
- They all have the same technical function.
- The classification for health and physical hazards is identical.
- The toxicological profile is the same.
- For all possible combinations of the resulting mixture:
- The hazards identification is identical.
- The additional information (Section 2 of Part B) is identical.
While you will not need to include the justification in your submission, you need to keep records in house, if either the Appointed Body request you for further information, or if the inspector requests it.
The amended Annex VIII includes a list of Standard Formulas which specify components’ identity and concentration. These concentration ranges are generally broader than the allowed ranges specified in Annex VIII. Mixtures conforming to one of these Standard Formulas do not need to comply with these standard requirements with regards to the information on composition. The information can be instead provided as listed in the Standard Formula itself.
The list of Standard Formulas is exhaustive, and is limited to cement, gypsum and concrete products.
In most cases, a final mixture will conform 100% to standard formula. It possible though, that only part of the final composition, i.e. a MiM, can be identified as a standard formula. To use a standard formula means that all the standard formula’s component are present in the final product. This means that the final composition includes all the components listed in the standard formula plus others in addition to them. You cannot select and include only certain components from the Standard Formula.
Bespoke paints are mixtures formulated in limited amounts and on demand by the customer at the point of sale. Due to the potentially unlimited number of colour variations, it would be practically very difficult to include the UFI of the mixture on the label and submit the relevant information before placing each colour variation on the market.
There is no specific definition of the maximum amount which would fall under the scope of the exemption. Bespoke paints that are not supplied immediately following a direct request by the customer (professional user or consumer) at the point of sale are not covered by the exemption. This means that pre-orders by professional users or consumers, mixed for example in a warehouse, would require the generation of a UFI and the submission of information on the final paint as supplied.
You need to submit harmonised information according to Annex VIII. The information requirements are the same in all Member States where you intend to place the mixture on the market. Details are available in the ‘Information requirements for poison centre notifications’ in brief document – available from ECHAs Poison Centre website in the Publications page under the Support tab.
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 have information on the composition of the mixtures being imported in order to be able to comply with the CLP Regulation. 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. Ultimately, the non-EU supplier may decide, in agreement with the EU importer, to make a voluntary submission (via an EU-based legal entity) and provide the UFI to the actual EU importer, who will then make their own submission under Annex VIII referring to that UFI in the composition. This would allow the protection of the CBI of the non-EU supplier.
The phone service always needs to be available 24 hours a day 7 days a week. The phone 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.
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.
The transitional period applies to the Member State where the company has complied with national legislation before the relevant compliance date. By placing that same mixture in another Member State after 1 January 2021 can be considered a new mixture on that market. You will therefore need to notify following Annex VIII.
Annex VIII established specific compliance dates according to the end use of the mixture. Whether you are making a new notification, or updating an existing one, you will have to make a notification in accordance with Annex VIII before placing it on the market after 1 January 2021 (consumer use and professional use) or 1 January 2024 (industrial use only). A notification has to be submitted in each Member State where you intend to place the mixture on the market.
It is at the discretion of a Member State to allow the submission of information in a new format before the first compliance date. ECHA has compiled a table with Member States’ decisions on when they will start accepting submissions according to the new format – more information is available from ECHA’s Poison Centre website in the ECHA Submission portal page under the Tools tab. If a Member State has incorporated the harmonised format in their national legislation before 2021, the labelling requirements, including the UFI, must be met as well.
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 are required to submit information according to Annex VIII (i.e. in case of changes to existing mixtures or new mixtures), you are also required to relabel your mixtures with the UFI code.
The notifications already submitted under national legislation 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. If you intend to place the same mixture on the market after 1 January 2025, a submission according to Annex VIII will be required starting from that date.
Companies can start generating their UFIs and perform internal preparations such as the mapping with formulation numbers used to generate the UFI. However, placing the UFI on the product label should coincide with the submission of information to the Appointed Body of the relevant Member State. It is not recommended to place the UFI on the product if it has not been included in a prior submission, as this would lead to ‘empty UFIs’ on the market with no relevance for emergency health response.
Yes, a company can generate multiple UFIs for the same mixture, placed on the market under the same or different trade names. Potentially, the same UFI can be used by different companies along the supply chain, as long as the composition remains the same. The UFI is linked to a mixture composition rather than a product, which means that you can have one or more UFIs for the same mixture, regardless of any trade names associated to it
The management of the UFIs is relatively flexible, and can be adapted to the business needs of the companies. This means that you could decide, for example, to assign different UFIs according to the market area, or according to the language, or according to the trade name.
The VAT number is only a means to generate UFIs. After the UFI is generated, this does not need to be linked to a specific company. The same UFI can be used by different companies as long as the composition of the mixture remains the same.
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 company 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, companies are to use their own VAT number to generate their UFIs.
For companies using the online UFI Generator tool, a tick box is available to avoid disclosing the VAT or in case no VAT is available.
For companies who have implemented the UFI algorithm into their own systems, a ‘company key’ can be generated and used instead of the VAT if there are concerns.
Note that it is possible to use the same UFI by different companies, as long as the composition is the same and the interested parties agree so. In this case there is no need to generate a new UFI by each single company.
The use of the UFIs is flexible. In principle, you can use one single UFI for all your customers along the supply chain, as long as the composition remains the same. To generate the UFI, you can use either your own VAT number for one single UFI or create UFIs for your customers with their VAT numbers. Note that if the mixture is placed on the market under different trade names, all these and each UFI number have to be included in a submission made by you or your customers.
Please consult the Guidance on Annex VIII (section Toll formulator and UFIs in particular) available from ECHAs Poison Centre website under the Support tab for more details.
The UFI must be on the label or in close proximity to the other labelling elements on the packaging of all hazardous mixtures in accordance with Annex VIII and included in the submission of information. Note that there are derogations for the UFI labelling. In the case of mixtures used at industrial sites only, the UFI may be indicated in the SDS (section 1.1) instead of on the label or packaging. As for mixtures not packaged, the UFI must be included in the SDS (Section 1.1).
For the submission of mixtures outside of scope, including the UFI on the label of non-hazardous mixtures will remain voluntary.
The UFI has to be clearly visible, legible, and indelibly marked i.e. it can't wash off. Printing techniques need to meet these requirements. The UFI must be easily identifiable by checking the label or next to the labelling elements. Please consult the Guidance on Classification and Labelling and the Guidance on Annex VIII (section Display, position and placement of UFI in particular) available from ECHAs Poison Centre website under the Support tab for more details.
It is not necessary to include the UFI on each layer of packaging, as long as it included on the inner packaging. In cases where it is not possible to include the UFI on the inner packaging, it can be affixed on a fold-out label or the outer packaging, always within close proximity to the other labelling elements. Further details on the considerations and exemptions from the labelling and packaging requirements are covered in the Guidance on labelling and packaging.
You have three possibilities. If you know all the components of the MiM, you need to list them like you would do with the other substance components of your mixture. If you do not know all the components of the MiM, you can use the UFI of the MiM together with its product identifier and concentration information, provided that the MiM has been notified by the supplier in the same Member State. If the UFI has not been notified in the Member State, then you can identify the MiM by providing its product identifier, together with its concentration and compositional information contained in the MiM SDS and any other known components, along with MiM’s name and the details of the supplier.
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.
Establishing good communication in the supply chain is a key factor. 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.
In any case, putting the UFI on the label of non-hazardous mixtures voluntarily notified will also remain voluntary.
When submitting information on a mixture, the duty holder must comply with the compliance date 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 relevant compliance date) set for consumer or professional use.
In the situation where the component purchased from different suppliers is identical (i.e. same composition and hazard profile):
- You do not need to provide all the UFIs. The one that has been notified in the relevant country will be enough.
- You do not need to provide the details of all suppliers, if the UFI is not available or not notified in the relevant Member State.
If you cannot be sure that the two MiMs are the same, it cannot be assumed the composition of your final mixture remains the same, therefore, you will need to submit two different notifications. In such cases, you can assess if you can benefit from the interchangeable component groups, one of the workability solutions.
Online preparation of notifications in IUCLID Cloud offers a user friendly interface for PCN notifications. In addition to this, preparing in the Cloud means you can safely store all you data online without having to concern yourself with any maintenance or updates of the tool, nor with backing up your data. Online preparation also simplifies the submission process in the Submission portal with the click of a button.
Offline preparation using IUCLID 6 offers the same interface as online preparation allowing you to maintain all your information locally. Users will however, need to download the latest version from the IUCLID website and install and maintain it themselves. A server version is available for multi-user companies.
ECHA released the first operational version of the ECHA Submission Portal in April 2019 allowing companies to prepare and submit notifications and appointed bodies to receive them. Please refer to the table ‘Overview of Member States’ decisions on implementing Annex VIII of the CLP’, available from ECHAs Poison Centre website in the ECHA Submission portal page under the Tools tab to see when each Member State will accept notifications via the ECHA Submission portal. If the Member State you would like to submit to, is not yet accepting notifications, you will need to follow the national rules in place.
If the Member State has indicated that they are not yet receiving notifications, your notification will stay pending in the database until the Member State is on-boarded and ready to receive notifications.
While the majority of the Member States have expressed their plans to rely solely on the ECHA Submission portal to receive notifications, some Member States have indicated that they will adapt their national submission systems to receive poison centre notifications, and will operate in parallel to the ECHA Submission portal. 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.
In principle, you need to make a submission to the appointed body in every Member State where you place on the market in the language of that Member State. The ECHA Submission Portal supports the multi-country submission by dispatching the notification to the relevant appointed bodies.
Yes, by making use of the foreign user functionality in the ECHA Account management, it is possible that a consultant can submit on behalf of yourself as the duty holder. However, be aware that you remain liable for the information submitted. Please see the ECHA Accounts Manual on how to work on somebody's behalf available from ECHAs Poison Centre website in the ECHA Submission portal page under the Tools tab.
A notification submitted through the ECHA Submission portal is available only to the relevant appointed body, who will then grant access exclusively to authorized persons This information will be used solely for emergency health response purposes. .
Upon further agreement, the statistical information gathered on incidents could be shared to identify potential needs for preventative measures.
ECHA’s IT tools allow you to validate your own information before you submit it. In addition, there are a number of additional automated checks against information contained in the database which are carried in the Portal upon submission.
Regardless of the support offered by ECHA’s automated validation tool, it will not replace any possible manual verification performed by Member States. Therefore, validating the quality or adequacy of the information submitted will remain at national level.
During the dossier preparation phase, the ‘validate’ functionality can check the dossier information prior to submitting using a set type of rules, e.g. if a valid UFI has been provided. A validation report will be available to assess the rules that were triggered (if any) and edit any information as a result.
A second validation will also occur in the portal after you submit your dossier. These include additional checks that can only be checked by the portal itself, e.g. if the UFI has already been submitted. After the dossier has been submitted, a validation report containing the results from the full set of checks will be visible to both you and the appointed body at the same time.
Two databases (one with the existing notifications and one with the new notifications) can co-exist at national level. The decision to migrate (incorporate existing data to the new database) is at the discretion of Member States.
Currently there is no plan to facilitate the transfer of information already submitted via the current national systems into the ECHA Submission Portal. Each Member State will decide how to manage the information already submitted nationally. Please, note that if you have notified a mixture to the national system, you may benefit from the transitional period until 2025 (unless a change to the mixture occurs).
According to Annex VIII to the CLP Regulation, submissions have to be made in the official languages of the Member States where the mixture is placed on the market, unless the Member State has specified otherwise.
The list of accepted languages for each Member State can be found in the Overview of Member States’ requirements for language(s) of notifications.
In your PCN dossier, indicate all the relevant languages in the dossier header. Free text fields will become available for the languages specified, for:
- Toxicological information
- Justification for update when "Other" is selected Additional text in Labelling --> Hazard statements
- Additional text in Labelling --> Precautionary statements
- Reproductive toxicity --> Specific effect
- Additional hazard classes
- Additional hazard statements
- Additional non-GHS hazard statements --> Additional text
Although ECHA itself will not charge any fees, 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. Please consult the table ‘Member States’ decisions on implementing Annex VIII of the CLP’, available from ECHAs Poison Centre website in the ECHA Submission portal page under the Tools tab for more details.
No, this functionality does not exist in the ECHA Submission portal and such communications will be required to take place through a different channel. You are encouraged to consult with the relevant appointed body before you submit to understand your obligations.
Currently the online preparation and submission tools are only available in English, i.e. the user interface and the selectable criteria in the form of picklists. Nevertheless, there are several free text fields e.g. toxicological information that requires you to manually enter the information in the language accepted by the Member State.
This week in Helpdesk
This week in Helpdesk
- Submitting before the compliance date (corrigendum)
- Toll formulators and PCN
- EU importers/UK suppliers (corrigendum)
- Legal submitters & foreign users
- Generic product identifiers
- UUID Numbers
- UFI in the SDS