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Substances fulfilling one or more of the criteria specified in Article 57 of the REACH Regulation can be identified as "substances of very high concern" (SVHC) and put on the "Candidate List". These SVHC can be:
- substances meeting the criteria for classification as carcinogenic, mutagenic or reprotoxic (CMR) category 1 A or B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008
- persistent, bioaccumulative and toxic (PBT) substances or very persistent and very bioaccumulative (vPvB) substances (according to the criteria of Annex XIII of the REACH Regulation)
- substances for which there is evidence for similar concern (Article 57(f) of the REACH Regulation), such as endocrine disruptors
Substances are identified as SVHC according to the procedure established by Article 59 of the REACH Regulation.
The Candidate List is updated when substances are identified as Substances of Very High Concern (see above). This is normally done twice per year (in June and December). To allow interested parties to be aware of substances which might be included in the Candidate List, a Registry of Intentions is published on the website of ECHA. As a producer or importer of articles, you are advised to regularly check the Registry of Intentions. This can help you to prepare for possible obligations that could arise when a substance is included in the Candidate List.
Article 3(3) of the REACH Regulation defines an article as "an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition". Chapter 2 of the Guidance on requirements for substances in articles provides information on how to determine if an object fulfils the above definition, including instructions on how to address borderline cases (Appendix).
Packaging is considered a separate article under REACH. Please refer to section 2.3 of the Guidance on requirements for substance in articles for more information.
There is no fee charged for the notification.
If the production/import ended before the substance was included in the Candidate List or before the notification obligation starts to apply (i.e. 1 June 2011 for substances placed on the Candidate List before 1 December 2010 or 6 months after a substance has been included in the Candidate List) then you do not have to notify. Please note, however, that for the information requirements specified in Article 33 of the REACH Regulation the date of supply of the article is the relevant date, i.e. the obligations also apply to the producers and suppliers of articles which were produced or imported before the substance was included in the Candidate List and are supplied after the inclusion. Please refer to section 4.3 of the Guidance on requirements for substances in articles for additional information.
Once a substance enters the Candidate List you have to determine if you have the obligation to notify. One of the inputs needed to determine this is the tonnage of the substance in imported/produced articles per calendar year (or the average of the three previous years if the article has been imported/produced during three years before the start of the notification obligation). In this calculation, you have to include the tonnage in articles imported/produced for the full calendar year, i.e. if applicable, also before the date of the inclusion of the substance in the Candidate List. However, if the three year average is not available, the notifier will need to rely on the amounts of the previous calendar year.
The notification obligation also applies to producers or importers of articles containing recycled material.
If you are a producers or importer, you must assess whether the articles you produce or import fall under the criteria of Article 7. It may be difficult to know the exact concentration of a Candidate List substance in, for example, recovered polymers where the concentration varies between each batch.
If your company concludes that the articles contain less than 0.1% of the Candidate List substance, we recommend you to document your basis for this conclusion in case of enforcement.
Yes. The only representative has to be a natural or legal person established in the Community to fulfil the obligations of non-EU manufacturers under Title II of REACH (Article 8).
The provision of Article 7(2) on notifying Candidate List substances in articles is part of Title II of the REACH Regulation. Therefore, an OR can be appointed by a producer of an article outside the EU to submit a substance in articles notification.
The notifications will not trigger a decision to register the substance in articles, as such. However, the notification information can be used in addition to several other sources (e.g. registration information) to support identification of further needs for risk management.
If there are grounds for suspecting that the substance is released from the articles under normal or reasonably foreseeable conditions of use and such a release presents a risk to human health or the environment, you may be required as a producer or importer of articles to submit a registration. These decisions will be taken on a case-by-case basis and are not restricted to Candidate List substances.
Enforcement of the REACH Regulation, including the obligation to notify Candidate List substances in articles, is in the remit of the authorities of the individual Member States.
You can find the contact details at: http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks.
You should contact your national REACH helpdesk: http://echa.europa.eu/support/helpdesks/national-helpdesks
If you have questions on technical issues on REACH-IT, the link is available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it and for questions related to IUCLID 6 at: http://iuclid.eu/ or if you are not in the European Economic Area (EEA), you may contact the ECHA Helpdesk: http://echa.europa.eu/support/helpdesks/echa-helpdesk.
If you would like to check your general obligations under the REACH Regulation and how to fulfil them, you should use the Navigator: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.
For general guidance on the provisions of REACH that apply to substances in articles, you should consult the Guidance on requirements for substances in articles available at: http://echa.europa.eu/guidance-documents/guidance-on-reach.
For guidance on how to submit a notification (Article 7(2) of REACH), you should consult:
- the "Notifying substances in articles" page whether you are submitting using the webform or through REACH-IT: http://echa.europa.eu/support/dossier-submission-tools/reach-it/notifying-substances-in-articles
- the Manual "How to prepare a substance in articles notification" if you are submitting through REACH-IT http://echa.europa.eu/manuals
You are exempted from notifying if:
- you can exclude exposure of humans and the environment to the Candidate List substance in the articles during normal or reasonably foreseeable conditions of use, including disposal. Chapter 6.3 of the Guidance on requirements for substances in articles provides information on exposure-based exemptions from notifying: http://echa.europa.eu/documents/10162/13632/articles_en.pdf
- The substance is already registered for that use. Chapter 6.4 of the Guidance on requirements for substances in articles provides advice on how to find out if the substance is already registered for that use: http://echa.europa.eu/documents/10162/13632/articles_en.pdf
If you conclude that you are exempted from notifying, in line with one of the two cases above, we recommend that you carefully document the basis for and the reasoning behind this conclusion. In this way, you will be prepared for any enforcement activities at national level.
A producer/importer of an article wanting to demonstrate 'exclusion of exposure' has to ensure that the Candidate List substance does not come into contact with humans or the environment during the use and disposal of the article. For more information on exposure-based exemption from notification see chapter 6.3 of the Guidance on requirements for substances in articles (http://echa.europa.eu/documents/10162/13632/articles_en.pdf). Note that in practice it may be more difficult and costly to demonstrate "no exposure" than to make a notification.
A substance has already been registered for a particular use, if two conditions are fulfilled:
- The substance in question has already been registered, and
- The use in question is the same as one of the uses described in an existing registration of this substance.
For more see chapter 6.4 of the Guidance on requirements for substances in articles.
ECHAs dissemination portal (http://echa.europa.eu/information-on-chemicals/registered-substances) contains information on registered uses, taken from section 3.5 of the IUCLID registration dossier and based mostly on the so called use descriptors. However due to the generic architecture of the use descriptors, this description is generally not sufficient to conclude on the sameness of two uses for the purpose of establishing whether an exemption on the basis of Article 7(6) of the REACH Regulation applies. The published information that a substance has been registered for use in the Article Category 'Plastic articles' does not necessarily mean the registration is made to cover all plastic articles. It could mean that use of the substance in production of some specific plastic articles is covered and described in the registration, while other plastic articles are not covered and assessed. The uses of two very different plastic articles may lead to very different exposures to humans and the environment. If the exposure related to the use of your article is not adequately assessed in a registration dossier, it cannot be considered a registered use.
Please note that there are limited possibilities to include information in section 3.5, apart from the use descriptors. Section 3.5 of the IUCLID registration dossier may however contain 'free text' information, which is not based on the use descriptor system. Whether such information is sufficient to conclude on the sameness of use has to be examined on a case by case basis.
Most producers of articles are also downstream users under the REACH Regulation and as such have certain obligations outlined in Title V of the REACH Regulation. Since most substances on the Candidate List are already registered, producers of articles should already have communicated their use to the registrant for the purpose of registrations. Producers of articles will therefore not have to notify in most cases.
Importers of articles may not have access to detailed information on registered uses. If you are not certain that your specific use is already registered you should notify.
Notification requirements apply only to substances already included in the Candidate List and meeting the criteria in Article 7(2) of the REACH Regulation. Therefore, if a substance is not yet in this list there is no need to notify. However, please note that CMR/PBT/vPvB and substances of equivalent concern that fulfil the criteria of Article 57 of the REACH Regulation can be included in the Candidate List. It is advised to keep track of the use of these substances in your articles and to follow the development of the Candidate List via the Registry of Intentions. By signing up for the ECHA e-News (http://echa.europa.eu/news-and-events/news-alerts) you will be alerted every time the Candidate List (http://echa.europa.eu/candidate-list-table) or Registry of Intentions (http://echa.europa.eu/addressing-chemicals-of-concern/registry-of-intentions) is updated with new substances.
One of the conditions that triggers your obligation to notify is when the concentration of the Candidate List substance exceeds 0.1% w/w in the article.
You should calculate the concentration of the substance for each article as produced or imported. This threshold applies to each article of an imported object made up of more than one article, which were joined or assembled together.
One of the conditions that triggers the obligation for you to notify is when the total amount of the Candidate List substance present in all articles produced and/or imported exceeds one tonne per actor per year.
The articles concerned should contain more than 0.1% w/w of the substance. If an article contains the substance at a concentration below 0.1% w/w, this article does not have to be included in the tonnage calculation.
The one tonne per year limit applies to the total tonnage produced/imported, in the European Economic Area (EEA) by the same legal entity. The tonnage is not calculated separately for different EU Member States if the legal entity is the same.
If you believe you are close to one of the thresholds but are unsure whether you exceed it or not, we recommend you to notify.
Chapter 4.5 of the Guidance on requirements for substances in articles provides explanations and examples on how to calculate this.
The information you need can often be derived from standardised information that is obtained from suppliers of substances/mixtures based in the European Economic Area - EEA (e.g. safety data sheets (SDSs) or, where a SDS is not required, safety information and regulatory requirements (Article 32 of the REACH)).
In the EEA, suppliers of articles containing more than 0.1% of a Candidate List substance must provide available and relevant safety information (Article 33 of the REACH), including, as a minimum, the name of that substance.
Proactive requests in the supply chain are often useful to obtain the necessary information, in particular when the supplier of the article is outside the EEA. As a last resort, chemical analysis of the article could be considered.
For more information, see Chapter 5 of the Guidance on requirements for substances in articles:
The obligation to notify under Art. 7(2) of REACH and to communicate down the supply chain under Art. 33 of REACH only applies to articles which contain Candidate List substances.
Certain boron substances included in the Candidate List, such as diboron trioxide, boric acid and disodium tetraborate, are involved in processes leading to the production of articles containing “borosilicate glass”. In these processes, the boron substances are usually first chemically transformed into a manufactured glass substance. The glass substance is subsequently processed into articles. In these usual cases, the boron substances are completely transformed and not be present as such in the final glass article. Consequently, there is no obligation to notify under Art. 7(2) of REACH, nor to communicate information down the supply chain under Art. 33 of REACH.
Please note that it remains the responsibility of companies to assess for their specific use of the Candidate List boron substances whether these are completely transformed into glass in the manufacture of “borosilicate glass” and whether the Candidate list substance is present in the boron glass articles.
The webform contains all the necessary instructions needed to succesfully fill in and submit your notification.
This information should be provided in the IUCLID file. As a minimum it includes the substance name and/or EC and CAS numbers.
To improve the submission process, ECHA publishes pre-filled substance datasets with substance identity information in the Candidate List.
Substance identity information is also available in the "supporting documentation column" of the same webpage. The manual "How to prepare a substance in articles notification" provides guidance on how to download and use these datasets:
The Candidate List can be found at: http://echa.europa.eu/candidate-list-table
This information should be provided in the IUCLID file. To improve the submission process, ECHA publishes pre-filled substance datasets with classification information in the Candidate List.
Classification information is also available in the "supporting documentation column" of the same webpage. The manual "How to prepare a substance in articles notification" provides guidance on how to download and use these datasets:
The Candidate List can be found at: http://echa.europa.eu/candidate-list-table
This information should be provided in the IUCLID file (section 3.5), by using the descriptor "Technical function of the substance". Chapter 5.9 of the Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it) provides guidance on how to fill these IUCLID section.
This information should be provided in the IUCLID file. There you should give:
- a brief description of the article and its use(s) in free text under "Further description of article" (section 3.5 of IUCLID).
- a brief description of the use of the article during its service life using the use descriptor system (section 3.5 of IUCLID). For articles the relevant descriptors are the following:
> Article category (AC) related to subsequent service life
> Environmental release category (ERC)
> Process category (PROC) for articles used by workers
> Technical function of the substanceExposure related description of article (section 3.5 of IUCLID)
- Indicate if the article is used by consumers and/or workers.
Similar articles with similar uses can be grouped under the same use description. Chapter 5.9 of the Data Submission Manual provide guidance on how to fill these IUCLID sections.
This information should be provided in the IUCLID file. There you should give: As a minimum requirement, the tonnage range is to be provided in the IUCLID Dossier Header. In section 3.2 of IUCLID, producers and importers of articles can indicate the tonnage of the Candidate List substance contained in the produced/imported articles. In section 3.5 you have the possibility to provide more detailed information (tonnage of substance per use) if you so wish. Chapter 5.7 of the Data Submission Manual provides guidance on how to fill these IUCLID section, including which years to base the calculation on.
Is it possible to include several sites in the same notification?Only producers of articles who manufacture their articles in the European Economic Area (EEA) will have to enter their production sites. Article importers do not need to fill in this information. Please refer to Chapter 5.8 of the Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it) for additional information. If a company has several sites producing articles, it can list all the sites in one notification. Different notifications should not be made for different sites if the sites belong to the same legal entity.
To facilitate the submission of notifications ECHA has made available pre-filled substance datasets in IUCLID format (i6z files) for substances on the Candidate List. These datasets contain information on substance identification, composition and classification and labelling. Each substance has its own pre-filled dataset, which can be downloaded from the Candidate List webpage. Chapters 3 and 4 of the Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it) provide information on how to download and use the datasets.
The registration number only needs to be included in the notification dossier if the substance has already been registered and the registration number is available to the notifier. If the article is imported from outside the EU, this field does not need to be filled. Producers of articles, incorporating the Candidate List substance into the article themselves, should normally have access to the registration number via the Safety Data Sheet (SDS) for the substance. In this case, the article producer is likely to be exempt from the notification obligation however he should verify that his use is indeed covered by the registration.
If available, the registration number should be provided in the IUCLID file (section 1.3). Chapter 5.5 of the Data Submission Manual provides guidance on how to enter this information in IUCLID.
Article 3(30) of the REACH Regulation specifies that "per year" means "per calendar year", i.e. 1st January – 31st December. However, for the purpose of the tonnage calculation, if the article has been manufactured or imported for at least three consecutive years the average volume of the preceding three years is recommended to be used. However, if the three year average is not available, the notifier will need to rely on the amounts of the previous calendar year.
Notification is required from producers or importers of articles, therefore you have to notify only when the object manufactured/imported is an article. Please refer to Chapter 2 of the Guidance on requirements for substances in articles for additional information on the distinction between a substance/mixture and an article.
The webform is an easy-to-use tool accessible from the ECHA website for notifying substances in articles. All instructions and information requirements to carry out the notification are provided at every step. Submitting the notification using the webform is recommended to all users, especially those who are not familiar with IUCLID.
The webform simplifies the notification process as there is no need to download a pre-filled substance dataset, use IUCLID or follow the data submission manual (these are necessary only when submitting via REACH-IT).
Be aware, however, that if you notify your substance in articles with the webform, none of the information submitted can be claimed confidential.
This method is recommended for notifiers who are already users of IUCLID and who want to maintain their report records in the REACH-IT system. It is also recommended to those who want to report a different substance identification, composition, or classification and labelling information or to those who wish to indicate part of the information included in the notification as confidential (in addition to information which is always treated as confidential, see Article 118 of REACH).
The notification is made using the IUCLID 6, which can be downloaded free of charge from the IUCLID web page (link to: http://iuclid.eu/) and submitted to ECHA via REACH-IT. The Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it) provides detailed and illustrative assistance to successfully carry out the notification.
To facilitate the submission of the information required to complete a notification, ECHA has created pre-filled substance datasets in IUCLID 6 format for substances on the Candidate List. These datasets contain information on substance identification, composition and classification and labelling. Each Candidate List substance has its own pre-filled dataset, which can be downloaded from the Candidate List webpage (http://echa.europa.eu/candidate-list-table).
Once you have created your Substance in Articles notification dossier, it is recommended to use the Technical Completeness Check (TCC) tool. This IUCLID 6 plugin will detect any missing information in your dossier before exporting it and submitting it to ECHA through REACH-IT. You can download the latest version of the TCC plugin from the IUCLID 6 web page (http://iuclid.eu/).
A notification of a substance in articles shall be made at the latest 6 months after the substance has been included on the Candidate List. The obligation started to apply from 1 June 2011.
If you have the obligation to notify a substance in your articles and the deadline has already passed you are encouraged to notify immediately. You might face national enforcement sanctions if you fail to meet the deadline. Although ECHA accepts notifications after the legal deadline, this does not prevent your national enforcement authorities to impose sanctions on you.
If the import of the substance starts after the notification deadline has expired (i.e. 6 months after the inclusion in the Candidate List), notifications must be made without undue delay as soon as the conditions related to the notification obligation are met, i.e. as soon as the 1 tonne per year threshold has been exceeded.
One notification should be submitted for all the articles produced or imported containing the same substance by/to one legal entity. You are however requested to indicate the uses for each different type of article in your notification.
No, it is necessary to submit a separate notification for each substance and for each importer/manufacturer.
In order to be able to demonstrate compliance with your obligations, you are recommended to update your notification if the information included in the notification changes. Examples of important changes could be: change in tonnage range, production/import of different articles (with e.g. different use) containing the same substance etc.
You cannot update a notification that was submitted with the webform. Instead, a new notification will need to be created from scratch and submitted to ECHA.
If you stop importing or producing articles containing a Candidate list substance, you should inform ECHA directly via REACH-IT using the "Cease manufacture" functionality.
If you submitted your notification of substances in articles using a IUCLID dossier, you can update your IUCLID dataset and submit the dossier update via REACH-IT.
If you stop importing or producing articles containing a Candidate list substance, you should inform ECHA directly via REACH-IT using the "Cease manufacture" functionality.
For more information, see Chapter 8 of the Data Submission Manual (http://echa.europa.eu/support/dossier-submission-tools/reach-it).