Vill du läsa svaren i avsnittet med vanliga frågor på ditt språk? I rullgardinsmenyn ovan kan du ändra språk.
The revised Waste Framework Directive 2008/98/EC, which entered into force in July 2018, provided a role for ECHA to establish and maintain a database with information on substances of concern in articles, as such or in complex objects (products), named the “SCIP database”.
The information is submitted by companies supplying articles containing SVHCs on the Candidate List placed on the EU market. The SCIP database will ensure that this information is available throughout the whole lifecycle of articles and materials, including at the waste stage.
The three main objectives of the SCIP database to support the circular economy are the following:
- Decrease the generation of waste containing hazardous substances by supporting the substitution of substances of concern in articles placed on the EU market.
- Make information available to further improve waste treatment operations.
- Allow authorities to monitor the use of substances of concern in articles and initiate appropriate actions over the whole lifecycle of articles, including at their waste stage.
The primary goal remains the substitution of the Candidate List substances of very high concern in articles with safer alternatives, and thus preventing the generation of waste containing those hazardous substances.
The information available in the SCIP database will support waste operators to improve their waste separation and recycling techniques and processes over time, based on the increased knowledge of which substances are present in which articles. Waste operators do not currently have sufficient information about hazardous substances in the waste they are processing –leading, in the worst case– to such substances being incorporated in recycled materials. The database aims to bridge the current gap in the information flow.
The increased transparency will also benefit consumers and give them the opportunity to make better informed purchase decisions, as well as give them transparent information on safe use and disposal advice for articles on the EU market.
Finally, improved knowledge of the presence and use of substances of concern will benefit authorities in their regulatory work.
Ultimately, the database should facilitate the transition to a more sustainable material management by increasing the efficiency of resource use, and ensuring waste is valued as a resource.
Duty holders only need to provide information on those articles which contain Candidate List substances. The vast majority of articles on the EU market do not contain them.
Substitution remains the overall goal: the most hazardous substances should be phased out over time.
The information required for the SCIP database must already be communicated throughout the supply chain under REACH Article 33(1). The SCIP database therefore complements the existing communication and notification obligations for Candidate List substances in articles under Articles 33 and 7(2) of REACH, and should reinforce compliance with them.
ECHA has introduced features for reusing the information already submitted by the upstream supplier to allow duty holders to refer to each other’s notifications in case it concerns the same article, thereby reducing administrative burden and avoiding duplications. Please see Reusing data.
ECHA has also provided a system-to-system (S2S) submission solution which will automate the submission process for these articles. Companies are also able to connect their supply chain tracking tools to the SCIP database to set up automated submission procedures and avoid manual work.
Since the beginning of the project, ECHA has been in contact with several industry sectors and supply chain communication-tool providers to understand the needs and existing practices.
No, the aim of Article 33 under REACH is to ensure that sufficient information is communicated down the supply chain to allow the safe use of articles by actors in the supply chain, professional and industrial end-users, and consumers. The information flow along the supply chain enables all operators to take, at their stage of the use of the article, the appropriate risk management measures to guarantee the safe use of articles containing Candidate List substances. The information should also allow the operators in the supply chain and consumers to make informed purchase choices on the articles they buy. The SCIP notification obligation under the Waste Framework Directive is aimed to ‘ensure that the information about the presence of substances of very high concern is available throughout the whole life cycle of products and materials, including at the waste stage’ (emphasis added, see recital 38 of the Directive (EU) 2018/851) and it complements the obligations already existing under REACH by also allowing waste operators to access the data. For more information see Q&A 1605.
Since REACH entry into force on 1 June 2007 onwards, companies have been required to comply with their communication obligation under Article 33 of the REACH Regulation. According to Article 33 (1), a supplier of an article which contain such a substance of very high concern on the Candidate List in a concentration above 0.1 % (weight by weight) must provide enough information to allow the safe use of the article to customers, i.e. industrial or professional users and distributors. Consumers can request similar information.
As from 5 January 2021 onwards, information on articles containing a Candidate List substance of very high concern above 0.1 % (weight by weight) needs to be submitted to the SCIP database maintained by ECHA.
ECHA understands that Directive 2018/851 of 30 May 2018 amending Directive 2008/98/EC on waste is still under scrutiny for incorporation into the EEA Agreement. For more information you are advised to contact the relevant EEA institutions. EEA countries cannot make SCIP notifications until the WFD is incorporated in the EEA Agreement.
As of the date publishing of this Q&A, the following countries can make SCIP notifications: Austria (AT), Belgium (BE), Bulgaria (BG), Croatia (HR), Cyprus (CY), Czech Republic (CZ), Denmark (DK),Estonia (EE), Finland (FI), France (FR), Germany (DE), Greece (GR), Hungary (HU), Ireland (IE), Italy (IT), Latvia (LV), Lithuania (LT), Luxembourg (LU), Malta (MT), Netherlands (the) (NL), Poland (PL), Portugal (PT), Romania (RO), Slovakia (SK), Slovenia (SI), Spain (ES), Sweden (SE).
Legal entities from the United Kingdom or Northern Ireland are not allowed to submit SCIP notifications. The Waste Framework Directive (WFD) is not listed in the Annex to the Northern Ireland Protocol. Consequently, there is no obligation for the UK to comply (in respect of NI) with any of the obligations of the WFD. United Kingdom (including NI) suppliers of articles to EU-based companies are in the SCIP context non-EU suppliers. For further details see Q&A 1610 and Q&A 1698.
For more information, we kindly invite you to contact your United Kingdom authorities.
- The substance is present in their relevant articles above a concentration of 0.1% (weight by weight).
- The substance is present in these relevant articles in quantities totalling over one tonne per year.
The responsibility for fulfilling the obligation of providing information to ECHA lies with the EU importers.
Companies outside of the EU are not subject to this obligation and are not allowed to submit SCIP notifications.
Importers of articles in the EU however, need to turn to their non-EU suppliers of articles and request information that they need to fulfil their regulatory obligations, such as the obligation to provide information to the SCIP database. As a non-EU supplier of articles, you should support your EU customers by providing them the necessary information about the presence of Candidate List substances in your supplied articles.
An EU importer may set up contractual agreements with their non-EU suppliers of articles to act on their behalf (as a ‘foreign user’1), regarding the submission of data to the SCIP database. However, the responsibility of the SCIP notification and its content still lies with the EU importer of articles. Please be aware that the third party users (‘foreign user’1) will see the same information as all other users in the ECHA IT Tools. For further information see Q&A 1665.
1 A ‘foreign user’ is an external user from company B who has been appointed by the Legal Entity manager from company A to work for company A. A foreign user can perform actions on behalf of the company that grants him permission to use an account from their own ECHA account. Granting access to third party users (foreign users) will allow them to see the same information as all other users. It is important that companies agree the scope of access and how for example confidential information is handled. For more information on the ‘foreign user’, please consult Q&A 960 and the ECHA Accounts Manual.
The information required for the SCIP database must already be communicated throughout the supply chain under REACH Article 33(1). Therefore, besides administrative contact details, suppliers of articles need to submit the following information to ECHA:
- information that allows the identification of the article;
- the name, concentration range and location of the Candidate List substance(s) present in that article; and
- other information to allow the safe use of the article, notably information to ensure proper management of the article once it becomes waste.
Duty holders can provide further information on a voluntary basis.
A detailed list of all information requirements is given in the "Detailed Information Requirements" document:
Article 9(1)(i) of the revised Directive 2008/98/EC on waste (hereafter referred to as the Waste Framework Directive or the WFD1) requires "that any supplier of an article as defined in point 33 of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council provides the information pursuant to Article 33(1) of that Regulation to the European Chemicals Agency as from 5 January 2021".
According to Article 33(1) of Regulation (EC) No 1907/2006 (the REACH Regulation): "Any supplier of an article containing a substance meeting the criteria in Article 572and identified in accordance with Article 59(1)3 in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance".
An objective4 of Article 33(1) of the REACH Regulation is to enable supply chain actors to manage the risks arising from the use of articles containing substances of very high concern (SVHC) that are put on the "Candidate List"5.
Article 9(2) of the WFD provides that information pursuant to Article 33(1) has to be included in a database to be used primarily by waste treatment operators. The information made available to those operators via the database has to be useful for the waste treatment phase of the article’s lifecycle, and enable the identification and effective treatment of waste containing SVHC, as laid down in recital 38 of the WFD elaborating the objective of the database:
"When products, materials and substances become waste, the presence of hazardous substances may render that waste unsuitable for recycling or the production of secondary raw materials of high quality… It is necessary to promote measures to reduce the content of hazardous substances in materials and products, including recycled materials, and to ensure that sufficient information about the presence of hazardous substances and especially substances of very high concern is communicated throughout the whole life cycle of products and materials. In order to achieve those objectives, it is necessary to improve the coherence among the law of the Union on waste, on chemicals and on products and to provide a role for the European Chemicals Agency to ensure that the information about the presence of substances of very high concern is available throughout the whole life cycle of products and materials, including at the waste stage.”
In view of these elements, the information to be provided to ECHA based on Articles 9(1)(i) and (2) of the WFD has to include information available to the supplier that allows:
- the identification of the article;
- the SVHC in the article, its concentration range and its location, as appropriate; and
- possibly any other information on the safe use of the article, notably information which is necessary to ensure proper management of the article once it becomes waste.
Therefore, the minimum available information which the supplier has to communicate to ECHA consists of:
i) information relevant to the identification of the article;
ii) name, concentration range and location of the SVHC;
iii) where information in point ii) is not sufficient, other information on the safe use of the article, in particular, available information that is relevant to ensure proper management of the article as waste.
ECHA may envisage the possibility for the supplier to provide other information on a voluntary basis.
ECHA has implemented this approach in the "Detailed Information Requirements" document for the database.
1 Directive (EU) 2018/851 of the European Parliament and of the Council of 30 May 2018 amending Directive 2008/98/EC on waste
2 Article 57 defines criteria for substances to be included in the Candidate List.
3 Article 59 sets out the procedure for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a Candidate List
4 Further details on the aim of REACH Article 33, please see subchapter 3.2.1 of the Guidance on requirements for substances in articles and paragraphs 77 and 78 of the judgment of the Court of Justice in case C-106/14.
5 See recitals 56 and 58 of the REACH Regulation.
(source: Commission non-paper on the implementation of articles 9(1)(i) and 9(2) of the revised Waste Framework Directive 2008/98/EC, distributed to the CARACAL and Waste Expert Group in June 2019, ref. Ares(2019)3936110)
The information submitted to the SCIP database will be publicly available and therefore readily available to waste operators to bridge the current gap in the information flow.
ECHA will publish the information, as received, on its website. The quality of the data remains the responsibility of each duty holder.
At the same time, ECHA will ensure the protection of confidential business information where justified. For example, the required mandatory data that allow to establish links between actors in the same supply chain will not be made publicly available.
The simplified SCIP notification (SSN) is a tool developed by ECHA to facilitate the fulfilment of the SCIP notification obligation without preparing a IUCLID dossier.
It is a simplified solution to refer, on a voluntary basis, to information already submitted to ECHA by another duty holder. A duty holder who submits a simplified SCIP notification remains responsible for the information contained in the submitted SSN. It is up to the individual actors in the supply chain, or otherwise, to enter into the necessary arrangements, if considered needed, to use SSN to fulfil the SCIP notification obligation.
The main target users of the simplified SCIP notification (SSN) are distributors. However, other duty holders may also use this tool.
For example, if you are a distributor you may refer voluntarily to information already submitted by an upstream supplier to ECHA within the same supply chain by submitting through the ECHA Submission Portal the SCIP number provided by your supplier on a voluntary basis. In this case, a pre-condition to use SSN is to have received the SCIP number of the article as such or complex object’s SCIP notification that has already been submitted to ECHA by your supplier. The SCIP number can be provided to you for instance together with the information communicated to you under REACH Article 33(1). The SSN is only applicable if the article as such or the complex object supplied to your customer is the same as the article or complex object that was supplied to you. E.g. As a distributor you are supplied a bicycle (with a SCIP number), you can then submit your own SSN in the ECHA Submission Portal using this SCIP number and will receive a new SCIP number from ECHA that you can then pass on to your customers.
Additional information on the scope of the SSN can be found in the manual “Tools to refer to SCIP data already submitted to ECHA”. A visual representation on how to use SSN via IUCLID can be found in the presentation “How to prepare and submit a SCIP notification" section “Simplified SCIP notification (SSN)”.
The ‘referencing’ in a SCIP notification is a tool developed by ECHA to facilitate the fulfilment of the SCIP notification obligation by allowing to refer, on a voluntary basis, to information already submitted to ECHA by another duty holder in their SCIP notification dossier for complex objects.
A duty holder who submits a dossier including ‘referencing’ for a complex object component remains responsible for the information they are referring to. It is up to the individual actors in the supply chain, or otherwise, to enter into the necessary arrangements, if considered needed, to use ‘referencing’ in their notifications.
The main target users of ‘referencing’ in a SCIP notification are assemblers. However, other duty holders may also use this tool.
When a duty holder needs to submit a notification to the SCIP database for a complex object placed on the market, i.e. an object made of two or more components, which can be either an article as such or another complex object component, a reference to a notification submitted by the supplier of that component or by the duty holder itself to the SCIP database will be sufficient. E.g. As an assembler of a bicycle you are supplied with units of a handlebar grip (with a SCIP number) and you incorporate them in a bicycle. Then you submit your own SCIP notification dossier for the bicycle using the supplied SCIP number of the handlebar grip using referencing, plus your own data. After submitting your bicycle SCIP notification, you will receive a SCIP number for the assembled bicycle that you are supplying to your costumers.
A pre-condition to use ‘referencing’ in a SCIP notification for an assembled complex object is to have received the SCIP number of the component’s SCIP notification that has already been submitted to ECHA by an upstream supplier.
Additional information on the scope of the ‘referencing’ in SCIP notifications can be found in the manual “Tools to refer to SCIP data already submitted to ECHA”. A visual representation on how to use referencing via IUCLID can be found in the presentation “How to prepare and submit a SCIP notification", section “Dossier preparation for a SCIP notification using ‘Referencing’”.
ECHA developed the Simplified SCIP Notification (SSN) to allow referring to information already successfully submitted to the SCIP database, without submitting a IUCLID dossier, to be primarily used by distributors, but it can also be used in other situations, for example by companies belonging to the same corporate group. For example, it allows different duty holders (within the same corporate group), companies A and B (duty holders) importing the same article to agree that one of them, company A, will submit a SCIP notification containing a dossier with all required information, and the other, company B, will use the SSN to refer to the information submitted by company A to ECHA. Note that each duty holder remains responsible for the SCIP notification and its content. Finally, it is up to the individual companies, or otherwise, to enter into the necessary arrangements, if considered needed, to use those tools to fulfil the SCIP notification duties.
While the obligation to submit SCIP notifications is individual for every duty holder, a corporate group may consider centralising the handling of SCIP notifications using a specific legal entity via the foreign user mechanism. A foreign user can support different duty holders by submitting SSN submissions on behalf of a duty holder based on mutual agreement.
The “Article category” in the SCIP database aims at providing summarised information on the function or use of the article containing the Candidate List substances or of the complex object incorporating such articles in the SCIP notification. It consists of a common understandable name or description of the article or complex object selected from a harmonised list.
The article category is selected from a pre-defined harmonised list based on the integrated Tariff of the European Union – TARIC – list named CN/TARIC codes and descriptions. The TARIC list incorporates the Combined Nomenclature (CN) codes and descriptions as set out in Annex I to Council Regulation (EEC) No 2658/87 and the specific TARIC subheadings.
The identification of the article or complex object in a SCIP notification based on its function or use cannot be ensured by the ‘article name’ on its own as assigned by the SCIP notification submitter, because it is a text field, can be submitted in a language other than English, can have a meaningless name for a user of the database. Furthermore, the ‘article name’ is also used to manage the data in the preparation and submission of notifications in the SCIP dossier and in the ECHA submission portal, which may include a name which may be meaningless for a user of the SCIP database, in particular for consumers and waste operators.The ‘Article Category’ (CN/TARIC codes and description) is also a key element to support the identification of impacted waste streams based on function/use of the article or complex object (e.g. textiles, batteries, construction and demolition, electrical and electronic equipment, end of life vehicles, packaging), once it becomes waste.
- Code: Numerical code - CN or TARIC code. The CN code corresponds to a number attributed to each subdivision of the Combined Nomenclature. The TARIC code is based on the Combined Nomenclature, with additional subdivisions.
- Description: CN or TARIC description associated to the CN or TARIC code.
- the Harmonized System (HS) which is a nomenclature developed by the World Customs Organization (WCO) comprising many commodity groups, organised in a hierarchical structure by
- the Combined Nomenclature (CN) - Annex I to Council Regulation (EEC) No 2658/87 – which is the EU's eight-digit (8 digits) coding system, comprising the HS codes with further EU subdivisions. Every year, this Annex I is updated and published as a stand-alone Regulation in the EU's Official Journal, in accordance with Article 12 of Regulation (EEC) No 2658/87, at the latest by 31 October. The updates to the CN list of codes and descriptions is managed by the European Commission (DG TAXUD), as provided in the ‘Code of conduct for the management of the Combined Nomenclature (CN)’;
- the Integrated Tariff – TARIC – which comprises the eight-digit code (8 digits) and descriptions of the Combined Nomenclature plus two additional digits (TARIC subheadings with 10 digits). The TARIC database is updated every month.
- The ‘TARIC database’, monthly extractions published in CIRCABC can be accessed through this webpage by clicking on [Info] under “User Guides, Information and Downloadable data: [Info]”, and on CIRCABC under the folder named ‘Nomenclature’.
- The ‘Trade helpdesk’ under ‘Find my product code’ in addition to Annex I to Council Regulation (EEC) No 2658/87
- On the ‘EU product classification system’ is available here
- On the Combined Nomenclature (CN) is available here
- On TARIC, the integrated Tariff of the European Union, is available here
- On IUCLID product, including planned releases, is available here
- Consolidated text of 01/01/2020 of Council Regulation (EEC) No 2658/87 of 23 July 1987
- Commission Implementing Regulation (EU) 2019/1776 of 9 October 2019
- Code of conduct for the management of the Combined Nomenclature (CN) – Commission Communication 2000/C 150/03
The obligation covers all articles placed on the EU market containing a substance of very high concern on the Candidate List in a concentration above 0.1% w/w.
Substances fulfilling one or more of the criteria defined in REACH Article 57 can be identified as Substances of Very High Concern (SVHCs) and put on the Candidate List for authorisation. New substances are regularly added to the Candidate List, usually twice a year.
The obligation applies to any article as such or in a complex object, i.e. an object made up of more than one article, because articles that are assembled or joined together remain articles. Furthermore, an import is deemed to be ‘placing on the market’, thus any imported article into the EU is covered by the obligation, including any supply via internet sales that involve an import.
The obligation covers articles, as such or in complex objects, as they are supplied, including “spare parts”. Articles or complex objects that are repaired, provided that they are not supplied, are not covered by the legal duty.
Information on articles supplied directly and exclusively to consumers, without the participation of a distributor or other actor in the supply chain, will not be included in the SCIP database, as any direct supply to consumers is not covered by the legal obligation.
Where necessary, in the interests of defence, Member States may allow for exemptions from the REACH Regulation in specific cases for certain substances on their own, in a mixture or in an article (Article 2(3) of the REACH Regulation).
Therefore, in case a Member State considers that the reporting obligations are detrimental to its national interests in the area of defence, then a Member State may choose to invoke this article to provide a specific exemption from the obligation of Article 33(1) of REACH, and to Article 9(1)(i) of the WFD1 respectfully. Furthermore, Member States are not obliged to supply information the disclosure of which they consider to be contrary to the essential interests of its security (Article 346 TFEU2)
1 Directive (EU) 2018/851 of the European Parliament and of the Council of 30 May 2018 amending Directive 2008/98/EC on waste
2 Treaty on the Functioning of the European Union.
(source: Commission non-paper on the implementation of articles 9(1)(i) and 9(2) of the revised Waste Framework Directive 2008/98/EC, distributed to the CARACAL and Waste Expert Group in June 2019, ref. Ares(2019)3936110).
Substances, mixtures and articles can be contained inside packaging, such as a carton, a plastic wrapping or a tin can. Packaging is to be considered as an article because its shape, surface or design is more important than its chemical composition for its functions. The packaging is not a part of the substance, mixture or article being packaged. It is therefore to be considered as a separate article under REACH and the same requirements apply to it as for any other article.
Furthermore, in complex objects, several articles can be joined or assembled together in various manners. A “complex object” refers to any object made up of more than one article. This does not necessarily exclude the possibility that in certain situations packaging may be one of those articles (e.g. a bottle, the can component in a spray can). Articles that are assembled or joined together remain articles, as long as they keep a special shape, surface or design, which is more decisive for their function than their chemical composition.
Any packaging or packaging components employed to package a substance, mixture or article is an article itself or a complex object and is subject to SCIP notification if that article or any of the articles incorporated in that complex object contains a Candidate List substance in a concentration above 0.1% w/w. For further information see Q&A 516.
A medical device is subject to a SCIP notification obligation if that medical device itself or one of its components:
- fulfils the REACH definition of article, and
- contains a substance of very high concern (SVHC) on the Candidate List in a concentration above 0.1% w/w.
The assessment on whether a medical device itself or one (or more) of its components, can be considered an article under REACH needs to be done on a case-by-case basis after identifying the function of the object. The identification of the function and the assessment should be done by applying the principles contained in the Guidance on requirements for substances in articles, Chapter 2, taking into account the worked examples therein (e.g. Appendices 3 and 4).
The exemption in REACH Article 2(6)(c) is only relevant for the provisions under Title IV of REACH that are applicable to mixtures. Article 33 is included under the same title of REACH, but it is applicable to articles as defined in Article 3(3) of REACH. Therefore, the exemption from Title IV of certain medical devices that are mixtures is not relevant in this context.
As a result, there is no exemption from the duty to communicate information under Article 33 of REACH for suppliers of medical devices fulfilling the REACH definition of article or incorporating a component fulfilling that definition, if it contains a Candidate List substance above 0.1% w/w. A supplier of a medical device fulfilling the REACH definition of article or incorporating a component fulfilling that definition is not exempted of the communication obligations under Article 33(1) and is therefore also not exempted of the SCIP notification obligation under Article 9(1)(i) of the Waste Framework Directive.
- a regulatory change that leads to a mandatory submission of up-to-date information, in particular when a substance present in an article (in a concentration above 0.1% w/w) is included in the Candidate List after 5 January 2021;
- a change in the composition of a complex object, in terms of components and subcomponents incorporating articles as such containing Candidate List substances;
- a request from a Member State authority to submit additional information to a SCIP notification, for example if the submitted information does not ensure compliance with the SCIP notification duty;
- any changes that the submitter considers relevant to update a SCIP notification on a voluntary basis, for example if a Candidate List substance present in an article has been substituted by a safer alternative.
As from 5 January 2021, information on articles containing SVHCs (on the Candidate List) in a concentration above 0.1% w/w placed on the EU market needs to be notified to ECHA.
According to Article 9(1)(i) of the Waste Framework Directive (WFD1), suppliers should provide to ECHA the information pursuant to Article 33(1) of REACH Regulation from 5 January 2021 onwards. The revised WFD entered into force on 4 July 2018 to be transposed into national law by Member States by 5 July 2020. Member States were required to ensure national rules were in place to oblige all suppliers to provide information to ECHA as from 5 January 2021.
The information requirements of the database were provided on the ECHA website in order to guarantee full transparency towards the stakeholders, allow sufficient time to adapt their IT systems, where necessary, and enable them to prepare their notifications in due time before 5 January 2021. A detailed list of all information requirements is given in SCIP support - Information requirements.
Source: Commission non-paper on the implementation of articles 9(1)(i) and 9(2) of the revised Waste Framework Directive 2008/98/EC, distributed to the CARACAL and Waste Expert Group in June 2019, ref. Ares(2019)3936110).
1 Directive (EU) 2018/851 of the European Parliament and of the Council of 30 May 2018 amending Directive 2008/98/EC on waste
Since 5 January 2021, if substances present in an article as such or in a complex object placed on the EU market in a concentration above 0.1 % w/w are added to the Candidate List, the supplier of that article need to submit a new SCIP notification under Article 9(1)(i) of the Waste Framework Directive or update a previous submitted SCIP notification for that article at the time of the next supply or placement on the market to any customer or as a result of an import, after the substance has been included in the Candidate List.
The Guidance on requirements for substances in articles, in its subchapter 3.2.1 concerning the communication obligation down the supply chain (under Art. 33(1)), mentions that the "information is to be provided to the recipient of the article when the article is supplied for the first time after the inclusion of the substance into the Candidate List". Therefore, a SCIP notification should also be submitted to ECHA when the article is placed on the EU market for the first time after the inclusion of the substance into the Candidate List.
For further information see the Guidance on requirements for substances in articles.
Besides an automated data validation, ECHA does not perform any other checks on the dossiers submitted to the portal. However, ECHA’s IT tools allow you to validate your own information before you submit. The validation results appear in a validation report.
You can ensure that your notification will be accepted in the ECHA Submissions Portal by validating your dossier before you proceed with your submission.
Regardless of the support offered by ECHA’s automated validation tool, it will not replace the quality, accuracy, completeness and robustness of the information submitted which remains the responsibility of duty holders.
A third party can create an ECHA account to submit data to the SCIP database on behalf of a duty holder. A link between the third party and the duty holder accounts can be made using the foreign user functionality in ECHA Accounts: the agreement reached between both parties is based on intra-party arrangements.
A foreign user can perform actions on behalf of the company that grants him or her permission to use an account, through an appointment made by the company’s Legal Entity manager, from their own ECHA account. For more information, please consult Q&A 960. Practical details on how to set up a foreign user link can be found in the chapters “User roles” and “How to add a foreign user” of the ECHA Accounts manual.
A foreign user needs to pay special attention to changing to the duty holder account before a notification to the SCIP database is made.
Duty holders will remain responsible for the notifications submitted to the SCIP database: since a notification must be submitted using the duty holder account, a duty holder can verify at any time the list of notifications submitted to the SCIP database. Duty holders that establish a foreign user link give visibility to the content of their account based on the roles selected. In addition, duty holders can remove the foreign user link at any time.
If you wish to update your SCIP notification and you are using IUCLID 6 to prepare your notification, you need to:
1. Update the information included in your dataset. The primary article identifier (type and value) in the dossier needs to remain the same.
2. Validate the updated dataset.
3. Create a new IUCLID dossier.
4. Submit the dossier created in step 3 on the ECHA submission portal.
If you wish to update your SCIP notification and you are using the System-to-system service, you need to:
1. Update the information and create a new dossier (.i6z file). The primary article identifier (type and value) in the dossier needs to remain the same.
2. Validate the updated dossier.
3. Submit the dossier on the ECHA submission portal
The submission of this dossier via the ECHA Submissions portal will be considered automatically as an update if:
a. The submission is made using the same ECHA account; and
b. The same primary article identifier (type and value) is part of your dossier.
Note: The SCIP number remains the same in the case where the duty holder submits an updated dossier. For further details please see Q&A 1695.
Using IUCLID 6
1. Download the reference substance package available in the Candidate List package and save these files in your desktop.
- If you are importing the Candidate List package for the first time, we recommend to import a specific substance dataset or all together by using the latest version of the “individual reference substance datasets” compilation. Import the reference substance dataset in the same IUCLID version you are using as available in the candidate list package.
- If you have already imported reference substances from the previous SCIP Candidate List package you can use the “Delta package reference substance datasets” compilation to import the new and updated reference substances.
- Note: The updated reference substances will overwrite its previous version in your IUCLID instance.
2. Open your IUCLID instance and import the reference files (or drag and drop them). You will now be able to find a Candidate List substance when you need to report it in the concern element section of your dossier.
If you are using System-to-system make sure that you use the reference substance of the same IUCLID format version as the rest of the submission.
The ECHA submission portal will check the number of documents that each IUCLID dossier includes.
Each file created in a IUCLID dossier counts as one document. The files of a dossier can be a dataset of an article as such, a reference substance used to identify the substance, a dataset of a complex object (each layer created in the article hierarchy), a picture and a disassembling instructions file.
The number of documents can be counted by uncompressing the IUCLID i6z file. Each file contained in the IUCLID dossiers counts as one document. The files in a dossier can be: *.i6d files (representing a dataset of an article as such / complex object, a reference substance used to identify the Candidate List substance, the dossier, the attachment description file), picture and/or disassembling instructions files, XML schema files, the css file or the manifest.xml file. For more details please see the Developers' Guide to the IUCLID i6z Format.
In order to find out more about ECHA Account roles and how to add a role using your ECHA Account you can refer to the ECHA Accounts Manual, chapters 3.3 and 6.4 respectively.