Glossary of Terms

Parts

Assembly

Number of component parts fitted together to perform a specific function.

As per ISO 7573 definition.

Part Name

Text designation of a part.

As per ISO 7573 definition.

Part Number

Unique identification of a part for a particular organization.

As per ISO 7573 definition.

Quantity

Total number of the particular part(s) necessary for one specific assembly.

As per ISO 7573 definition.

Declarations

Regulatory Compliance Declaration (RCD)

You can choose to provide a Regulatory Compliance Declaration (RCD) or a Full Materials Declaration (FMD) for a list of part numbers on BOMcheck. If you make an RCD then you will need to update the RCD every 6 months when more substances are added to the REACH Candidate List and other regulatory requirements.

Full Material Declaration (FMD)

You can choose to provide a Regulatory Compliance Declaration (RCD) or a Full Materials Declaration (FMD) for a list of part numbers on BOMcheck. If you make an RCD then you will need to update the RCD every 6 months when more substances are added to the REACH Candidate List and other regulatory requirements.

Pending

If you create a RCD or FMD on BOMcheck but do not sign the declaration with your password, then the status of the declaration is set to Pending. A Pending declaration is not published on BOMcheck for Manufacturers to access - a Pending declaration can only be viewed by you. If you want to publish a Pending declaration then you need to view it from the Account Overview page, approve it and then sign the declaration with your electronic signature by typing in your password. If you decide you do not want to publish the Pending declaration then you can cancel it.

Approved

An Approved declaration is published on BOMcheck for Manufacturers to access immediately. Manufacturers rely on the Approved declarations from their suppliers to manage the compliance of the Manufacturers’ assemblies and products. To comply with the US FDA regulations for electronic signatures, BOMcheck stores a complete record of all Approved declarations that the Supplier publishes on BOMcheck. In view of this, you cannot delete an Approved declaration.

You can make a new declaration for the same parts list, or update the existing Approved declaration for the parts list, to supersede the previous declaration. BOMcheck always shows manufacturers the declaration data which has the most recent Approval Date. If required ENVIRON can re-create the status of parts on the BOMcheck database at different times in the past (i.e. what was the compliance status of a supplier’s parts list on BOMcheck last week, last month, last year etc).

You see your superseded declarations listed on your Account Overview page. However, when you view a superseded declaration you will see that the part numbers on the superseded declaration are shown with a line through them to show that there is a more recently approved declaration for these parts.

Planned

You can create a RCD or FMD on BOMcheck with an effective date in the future, for example if you know how the declaration status of the parts list will change on that future date. In this case, the status of the declaration is shown as Planned. A Planned declaration is not published on BOMcheck for manufacturers to access - a Planned declaration can only be viewed by you. When the effective date is reached, the status of the declaration will change to Pending. If you want to publish the Pending declaration then you need to view it from the Account Overview page, approve it and then sign the declaration with your electronic signature by typing in your password. If you decide you do not want to publish the Pending declaration then you can cancel it.

Out-of-date

A RCD which is not updated at least once per year is set to Out of Date. If you have created a FMD and used the FMD to generate an RCD, then the RCD will be updated by BOMcheck when new substances are added to the BOMcheck list of regulated and declarable substances. As new substances will be added to the BOMcheck list at least once per year then an RCD which is generated from an FMD will never become set to Out of Date.

Functions

Authorised Individual (AI)

A person who has been granted permission to use BOMcheck for the purpose of completing RCDs and FMDs. Permission must be granted by the company or organisation the person represents and by Sphera BOMcheck through the application process. Each Authorised Individual will retain one distinct user seat which will be identifiable via the users professional email address. Each Authorised Individual will be linked to a Supplier or Manufacturer Suite account via the account DUNs number. Manufacturer Access accounts do not have Authorised Individual user seats and instead are granted free-of-charge read only access to BOMcheck via a generic credential account which can be shared by employees.

DUNS Number

A unique nine-digit identification number which is used to identify legitimate, registered businesses. Your company should already have a DUNS number for your registered business address. Your company may have several DUNs numbers, you should choose only one of these to use on BOMcheck as the unique combination of DUNS number and part number(s) is used to store and retrieve data in BOMcheck. You can find out your DUNS number, or apply for a new DUNS number, via Dun & Bradstreet.

Note: If you do not use a registered business address then Dun & Bradstreet may need to gather information from you about your business and may be charge you for this.

Note: You do not need to establish a D&B Credit File (Dun & Bradstreet will charge you a fee for this additional service). Instead, you should specify to Dun & Bradstreet that you want them only to create a DUNS number for your company.

Sales Packaging

Packaging which is used to protect goods and products and ensure their safe handover to the consumer. Sales packaging is made of different materials, such as glass, paper, cardboard, plastics, metals, Tetra Pak or composite materials.

For more information on packaging compliance obligations see Sphera EC4P.

Standards

IPC 1752A

IPC 1752A is the most widely data exchange format for RCD and FMDs. IPC 1752A is used to make RCDs for RoHS, REACH Candidate List, REACH Restrictions, IEC 62474 Declarable Substances List, Joint Industry Guide JIG-101 lists, battery substance restrictions, other regulated substances lists, industry substance restrictions and many other lists.

BOMcheck manages the IPC update to the IPC 1752A lists of regulated substances and RoHS exemptions every 6 months immediately after ECHA publishes the new REACH Candidate Lists in December and June. At the same time, BOMcheck drafts IPC 1752A lists with IT solution providers so that they can start to preparing updates to their systems.

The new IPC 1752A lists are available in BOMcheck within 6 weeks of ECHA publication of new REACH Candidate Lists. All BOMcheck users are notified in advance. IT solution providers can download the new IPC 1752A lists directly from BOMcheck Integration API or they can download the same lists from the IPC website.

IEC 62474

BOMcheck was appointed as the UK National Expert for the IEC 62474 standard in June 2012 and took on the role of EMEA regional coordinator in December 2012. The IEC 62474 database of restricted and declarable substances replaced the Joint Industry Guide (JIG) in January 2014.

BOMcheck is aligned with the IEC 62474 database of restricted and declarable substances and the IEC 62474 screening of REACH Candidate List Substances.

EN 50581 RoHS2 Technical Documentation

The EN 50581European Standard was published in September 2012 and officially endorsed by the European Commission in December 2012 as an approved method for compliance with RoHS2 Technical Documentation requirements. The standard provides a risk management system which enables manufacturers to rely on objective evidence of RoHS2 compliance provided by their suppliers. EU RoHS regulatory authorities expect companies to adopt the EN 50581 standard or provide evidence that their compliance approach provides equivalent quality levels.

BOMcheck consolidated the BOMcheck Industry Steering Group’s experience in complying with substances restrictions and CE marking directives to help write the EN 50581 Standard for RoHS2 Technical Documentation in 2012. We did this by taking an early draft of the EN 50581 standard and writing a draft guide on how the Steering Group companies would comply with these draft requirements in practice. We then organized several workshops to discuss the draft guide with the European Commission RoHS2 Working Group, the UK Government RoHS2 Regulators and the UK Government RoHS2 Enforcement Agency. This approach enabled the BOMcheck Steering Group companies to provide practical feedback to highlight the strengths and weaknesses in the draft standard so that the final standard could be improved to meet regulators needs and also the industry needs.

When the final standard was published we used the experience and understanding we gained from interacting with the regulators to publish the final version of the BOMcheck Guide to Using BOMcheck and EN 50581 to Comply with RoHS2 Technical Documentation Requirements, which you can download free-of-charge at www.bomcheck.net/rohs. The final version of the Guide has been reviewed by the European Commission RoHS2 Working Group, the UK Government RoHS2 Regulators and the UK Government RoHS2 Enforcement Agency.