コンプライアンス関連資料

SCIPデータベース

よくある質問

2021年1月現在、 EU REACH に基づき、報告義務のあるレベルの「極めて懸念の高い物質（SVHC）」を含む製品をEU市場に流通させる企業は、その製品情報を 製品中の懸念物質（SCIP）データベース に製品情報を登録する必要があります。

以下のFAQでは、企業が SCIPデータベースを利用する際によく見られる問題について解説します。

SCIPの要件

SCIPの遵守が求められるのは誰ですか？

製品レベルでSVHCの含有率が0.1%（重量比）を超える製品（「報告対象SVHC」）を扱う企業は、下流の顧客に通知する義務を負います。

EU市場に製品を流通させる、サプライチェーンにおける製品およびその他の部品のEU製造業者・組立業者、EU輸入業者、ならびにEU販売業者は、すべてSCIPデータベースへの提出要件を遵守する必要があります。

直接的な遵守義務を負っていない企業であっても、顧客が自社製品情報をSCIPデータベースに提出できるよう、必要なデータの提供を顧客から求められることがよくあります。

純粋に輸出向けの生産を行う場合でも、SCIPデータベースへの提出は必要ですか？

いいえ。EU市場に投入される製品のみが、SCIP届出義務の対象となります。EU域内で生産され、EU域外への輸出のみを目的とする製品は、その対象外となります。

As a manufacturer for other companies, do we have to report to SCIP?

This will depend on the business relationship. A company producing a product on contract for another company and then selling the product to the EU market could be considered as making the product available on the EU market. However, a company providing manufacturing as a service may not be. We recommend consulting a legal advisor or import/export consultant to review your potential obligations.

We ship products to distributors in the EU including to a few retailers, so who is responsible for the SCIP notification?

Retailers are not obligated to make submissions to the SCIP portal unless they are also acting as the importer or distributor. If they are acting as importer/distributor, then they must make the submission. We recommend reviewing your import/export structure with the recipient of the article to determine which supply chain actors may have such obligations.

Who is the producer of a product that is developed in EU, but manufactured by a contract manufacturer outside the EU?

The location where the product is designed does not constitute production. It is the manufacture location which determines where the product is produced. However, if the manufacturer is contracted to build the product, the developer could assume the responsibility to submit the dossier. This situation will vary depending on the structure of the supply chain and how supply chain actors interact to place the product on the EU market.

What about suppliers outside the EU? What obligations are they facing?

While suppliers outside the EU cannot make submissions to the database, they can still do the same processing as EU suppliers and make this information available to their customers and importers, who will need this information. The only difference is the ability/obligation to submit the information to the database themselves.

Is SCIP registration applicable to products placed on the UK market?

No. We have not heard of any intention within the UK to implement SCIP style requirements. SCIP requirements only apply to products placed on the EU market.

If we are a subcontractor for electronics for customers who put the machines on the market, do we have to submit our modules to the SCIP database? Or is it to be done by our customers?

The legal entity inside the EU placing the product on the market has an obligation to submit a dossier to the database. If you are a producer who produces the product for placing on the market, you may have an obligation as well. This will depend on the nature of the relationship with your customer. If you are simply contracted to build the product, you may not have any obligation. However, your customer may ask you to make a submission, or provide the SCIP data set or dossier to them.

What happens if a company has different divisions across different EU member states in regard to the “one legal entity account per company” requirement of the European Chemicals Agency (ECHA) SCIP portal?

One incorporated business entity within the EU should have one Legal Entity account within the ECHA SCIP platform. If these divisions are incorporated as separate companies, then they could have their own legal entity for SCIP submissions. If they are simply divisions of one company, then they would be covered under the mother company’s ECHA Legal Entity account.

SCIP提出データの更新

EUは年に2回、「極めて懸念の高い物質（SVHC）」を追加しており、当社の製品に含まれる物質が追加される可能性もあることを踏まえると、SCIPへの提出情報を更新する手順はどのようなものですか？

SVHC候補リストに新たなSVHCが追加され、その新物質が、以前にSCIPデータベースへ届出を行った製品に含まれる成形品に含まれている場合は、単に書類を適宜更新して再提出してください。SCIP届出情報は更新されますが、当該製品のSCIP参照IDは変更されません。

If I already submitted dossiers (including a subcomponent) to the SCIP database, and later I perform changes on that subcomponent in IUCLID 6 (e.g. its TARIC Code), does it update the already submitted dossiers automatically or do I have to create the dossiers again from the complex object (own product)?

Changes made in the IUCLID tool do not automatically flow to the SCIP database. You must make the changes to the article, then recreate the dossiers for the complex object which contains that article, and submit the new dossiers to the portal.

When a product with a previously submitted SCIP dossier has become obsolete, do we need to do anything to inform ECHA that we no longer import the product to the EU?

No. At this time there is no option to report a product as no longer available on the market. This could be something ECHA adds in the future. However, ECHA does provide the ability to indicate when a previously reported SVHC has been eliminated from a product which was previously notified.

SCIP Submissions

SCIPデータベースへの登録には、どのような情報が必要ですか？

SVHCの含有率が0.1%（重量比）を超える製品を供給する事業者は、SCIPデータベースに以下の情報を提出する必要があります：

物質の名称およびその安全な使用方法（当初／現在、 EU REACH）
報告対象となるSVHCを含む製品のカテゴリーを特定する（20,000件以上の選択肢から選択）
報告対象となるSVHCを含む材料または物質（混合物）の分類を特定する
複雑なオブジェクト内に、報告対象のSVHCを含む記事のリンク
報告対象製品に含まれる報告義務のあるSVHCの濃度範囲を特定する
その製品がEU域内で製造または組み立てられたかどうかを確認する

Instead of using a TARIC Code, is it acceptable to use an HTS Code?

The actual code which must be used is the ECHA Category Code from the ECHA-provided pick list. This can be downloaded from the ECHA website. This list mirrors the EU TARIC list, so the TARIC list can also be referenced in determining the code. While HTS/HS codes are similar to their TARIC counterparts in most cases, this is not true in all cases. The EU Trade Helpdesk tool provides the ability to convert HS/HTS codes to TARIC.

If we have a control board in our machine that has components that need SCIP reporting, but the board itself is proprietary and we don’t want the public or competitors to know what is on it, what can we do?

You are not required to reference the component manufacturer names or part numbers when including articles in your product’s dossier. Other unique identifiers are allowed to be used which will reference the articles in generic ways, thus protecting your proprietary information. GreenSoft’s GreenData Manager® (GDM) software utilizes these parameters and ALWAYS assigns Reference IDs to parts, masking supplier names and PNs and ensuring supply chain privacy.

The SCIP portal allows for grouping articles under a single registration. Has GreenSoft incorporated that strategy into their process?

Yes. By including the ability to use the alternate Unique ID data field for each product, products can be grouped as desired by the user. This includes the quasi-identical article grouping methodology recommended by ECHA, as well as the ‘Representative Article’ approach which has been proposed by industry stakeholders.

Are manufacturers required to submit all levels of product structure, not only the parent product and the actual component containing the SVHC?

Manufacturers are required to submit enough information for the end-of-life processor to find the declared article(s). Full Bill of Materials (BOM) information is not required. However, as an example, if an SVHC is present in a gasket within the thermostat of an automobile, simply listing the automobile and the gasket would not be sufficient. Detailing the presence of the gasket within the thermostat, within the intake assembly, within the engine, would allow the end-of-life processor to find the substance of concern during end-of-life processing.

We have a PCB board that contains an SVHC above the threshold and is used in several end products. Do we need to upload all those products in the SCIP database or can we enter it under a product family name?

Every product placed on the EU market which contains an article over threshold must have a corresponding SCIP submission. If the products are similar and all contain the same articles and SVHC profiles (for example, they all contain the same PCB board), then they could be combined into one submission, as long as all group members are uniquely identified, and the top level products are similar enough to be referenced by the same Article ID (TARIC).

Concerning a product containing both simple articles with SVHCs, and simple articles without SVHCs, should I declare the complete BOM of the complex article?

No. Only the top-level product and simple articles with SVHC should be included in the SCIP submission. Any simple articles without reportable SVHC content should be omitted from the SCIP submission.

Which SVHC version do we have to upload in SCIP?

SCIP information should reference the latest SVHC list, as published by ECHA. New SVHCs are added at least 2 times per year to this list, so producers should monitor the content of new SVHCs and update any submitted dossiers if the products are impacted by SVHC list changes. We recommend subscribing to our blog to receive updates on SVHC additions and other regulatory news via email.

How do you handle multiple manufacturer parts (AVL) under a single part used in my design?

Alternate sources can either be included (all sources listed as present), or you have the option of using only the primary parts in the dossier. This is per your preference.

How should we name our products (“unique ID”) in the database? What are the benefits of naming them as they are sold vs anonymized IDs?

Because two of the stated intents of the database are to (1) allow consumers to research information on products, and (2) to allow end-of-life processors to access this information, we would recommend using the product’s part number or model number, as marked on the product.

To what level is reporting required? For example, if an Integrated Circuit in my product contains an SVHC Candidate List substance > 0.1% by weight, is reporting at the Integrated Circuit level sufficient, or do I need to go down the actual location within the Integrated Circuit (such as the lead-frame within the IC)?

This depends on the structure of the item in question. If the first article into which the SVHC was incorporated is the entire IC, then the entire IC should be identified as the article as such. If the SVHC was incorporated into an article within the IC, then the internal article into which the SVHC first incorporated should be identified as the article as such. Details on how to calculate and report SVHCs can be found by reviewing Example 21 of ECHA’s “Guidance on Requirements for Substances in Articles”, available here: https://echa.europa.eu/documents/10162/23036412/articles_en.pdf.

Industrial products with long lifetimes have a lot of modernization & changing spare parts during their lifetime. But isn’t it correct that SCIP requires only information from the time the product is first put on the market?

That is correct. Modifications, updates, and improvements to a previously sold product do not require SCIP submissions. However, the existing submission must still be maintained and updated as the SVHC list changes for as long as you are making new units of the product available on the EU market. The individual units which were already sold do not need to be considered for SCIP compliance. Keep in mind that if you offer upgrades or spare parts on the EU market, you are placing these on the market, so you will need to review obligations to submit based on those spare parts or upgrades. As an example, I could sell a new hard drive as an upgrade to an older PC which I sold previously. While I would not be obligated to update the PC’s SCIP dossier, I would potentially need to create a SCIP dossier for the hard drive which I am making available.

If I have submitted a SCIP dossier to the database for a product which contains an Article with an SVHC, and I need to send a replacement (repair) part to the EU to repair a product previously sold, does that replacement part need its own SCIP submission? Even if the article was already listed in the master product’s SCIP dossier?

GreenSoft has had detailed discussions with ECHA representatives on this topic. The answer is yes: even if the part was included as part of the parent product’s previous SCIP submission, if you send a replacement part into the EU, you are making that part available on the market, and it must have a SCIP notification. The fact it has already been notified as part of another product is not relevant.

Get Help with SCIP Submissions

GreenSoft Technology offers a comprehensive SCIP Solution, including data collection, report generation, and direct submissions to the SCIP Database straight from our GreenData Manager software. Contact us to learn more!

お問い合わせ

Data and Data Collection

We don’t have Full Material Declaration on our products because a few suppliers were not able to provide us with the information. In this case, we don’t have a full material list on the products, including the packaging materials used. How should we treat this situation with respect to SCIP obligations?

If you don’t have Full Material Declaration data on the parts and materials, you must contact your suppliers and collect either SCIP Reference IDs or the data needed to build the full SCIP data set on the articles they are providing, including the reportable SVHC contained in the article. Please also note that packaging materials are evaluated as separate, individual articles, and are not considered part of the product itself.

Is GreenSoft able to handle data collection at a black box level, such as: servers, workstations, network switches, firewalls, etc.?

Yes. Ideally, we would collect the SCIP reference numbers for these items, and reference those as the objects containing reportable SVHCs with your product’s SCIP dossier. If the supplier is unable to provide the SCIP Reference ID, then we would work with the supplier to identify the articles and concern elements contained within the complex objects themselves.

What if an article supplier informed us of an SVHC presence but did not submit a SCIP entry? Does GreenSoft submit for them? How can we reference the article without this entry?

If no SCIP reference number exists for an article within your product, and you are aware the article contains an SVHC over reporting threshold, then we would need to collect and analyze the specific SCIP details (such as article/material categories, SVHC concentration, etc.) for the component, and include that in the data set used to construct the SCIP dossier for your product.

What if the data received from a supplier for a component didn’t go up to the article level? Eg. IC. How can you go to article level without supplier cooperation?

ECHA has advised that we load the data we have available. If we are aware the IC contains an SVHC over threshold, but have no ability to determine the internal article which contains the SVHC, we could load the IC itself as the article as such. However, we should continue to work with the supply chain to fill any gaps in data, so we can update the dossier to include more detailed article information per ECHA guidance.

管理

When will the enforcement of the SCIP regulation start? What are the penalties?

There is currently no indication as to when member states will begin enforcing compliance with SCIP notification obligations. No penalties have been discussed by the member state authorities to our knowledge. For this reason, it makes sense to ensure quality data and correct SCIP dossier structures are submitted, so in the event member states abruptly start applying enforcement activity, risk of non-compliance will be mitigated.

SCIPの導入・施行日はいつですか？

2021年1月5日以降、EU域内で市場に投入されるあらゆる製品または複合製品については、その製品にSVHCが重量比0.1％を超えるものが含まれている場合、ECHAのSCIPデータベースへの対応する登録が行われていなければならない。

SCIP リファレンス ID

別途販売・発送されるスペアパーツには、それらが付属する本体のものとは別のSCIP参照IDが必要ですか？

はい、部品が販売目的で市場に投入される場合、それらはEU市場に投入される独立した製品とみなされなければなりません。

We obtained a SCIP Reference ID, but how will we know if it will be updated when new SVHCs are released?

There is no way to know when a supplier updates their SCIP notifications. However, because the SCIP Reference ID remains constant, once you use their SCIP Reference ID in your product notification, you will always be tied to their most recent submission. Additionally, as you are referencing their submission, you don’t have responsibility for its contents.

Can we create our own Reference number?

No. The SCIP Reference ID number is generated by the SCIP portal at the time the product’s first dossier is submitted. This is an ECHA-generated Reference ID.