Compliance Gate Platform Risk Summary

This guide explains how the features of the Compliance Gate Platform were created. We also explain the limitations and risks of each feature.

Compliance Requirements Lists

Compliance Requirements Lists

risks Feature Information

+ Compliance Requirements Lists serve as a first step toward researching relevant requirements for a product.

+ We write summaries that can help you understand many of the key requirements.

+ We provide links to official sources. We recommend that you always check and take action based on official sources.

risksLimitations and risks

– We do not claim to cover all requirements that can apply to a certain product. We only cover the items listed in this document.

– The summaries do not contain the entire legislation text. Hence, it does not cover every single requirement, scenario, or piece of information. The sources are ultimately the authority.

– There can be errors in the summaries. The sources are ultimately the authority.

– We do not include information and graphics (ie., warning texts) that is available in standards that may be harmonised or referenced by a certain regulation. For example, the summary for CPSIA does not include information from ASTM F963-23. It is often necessary to purchase standards.

Examples

– We generally only cover EU regulations and directives, and US federal requirements – not EU national or US state-level requirements. However, there are some exemptions – that can be found in this document.

– EU directives are translated into national legislation in EU member states. There can be differences between these and the EU directives. We only cover EU directives and base the summaries on the English language texts available on EUR Lex.

– Some summaries refer to certain business operators, such as manufacturers, importers, and private labelers. That said, we recommend that you assume all entries to be applicable, even in case the business operator mentioned is not exactly matching your company (e.g. “manufacturer” whereas your company fulfils the role of an importer).

Technical errors could result in summaries not being added to the compliance requirements list, in full or in part. We test the platform weekly – but we cannot eliminate the risk of technical errors.

– We monitor official EU and US sources each month. However, we cannot guarantee that we catch everything that relates to the regulations listed in this document. Nor can we provide updates in real-time. Please read the Monthly Review Methology for more information.

– We check the source links each month. These can be removed, changed, or redirected to a new URL. When we detect this, we make updates – we cannot track changes in real-time. We also need time to implement changes.

Templates

Templates

risks Feature Information

+ All document/certificate and label templates are created based on official sources.

Example: Directive 2014/35/EU > ANNEX IV

This means that the template is only based on ANNEX IV of Directive 2014/35/EU.

+ We always disclose the source the template is based on.

risksLimitations and risks

– We do not claim to provide templates for all documents/certificates or labelling requirements in the EU or US.

– We do not claim to provide templates for all documents/certificates or labelling requirements that can apply to a certain product.

– A new version of the source may exist. Open the source link and select the latest consolidated version (if any) to ensure that your file matches the current requirements.

– There could also be scenarios in which the source we used for the template is not applicable (in part or in full).

– The downloaded file could lack text written in the editor fields as a result of file damage or software error. You must always check the file after download to ensure that it is not missing information.

– The referenced regulation could include additional document/certificcation or labelling requirements, or reference standards that do. Our templates only correspond to the specified source and scope (e.g. Directive 2014/35/EU > ANNEX IV).

– Sources can sometimes be open ended in the sense that it leaves certain decisions to the manufacturer or importer. For example, warning texts or precaution texts are sometimes not defined – and therefore not part of the templates.

Lab testing

lab testing

risks Feature Information

+ We refer our subscribers to third-party lab testing companies, mainly QIMA and TUV Rheinland.

+ Both QIMA and TUV Rheinland are accredited by multiple entities:

However, the specific accreditations can vary between branches and labs operated by the companies.

+ These companies can often help you identify applicable standards or testing requirements for products.

risksLimitations and risks

– We do not guarantee that they can always provide an accurate assessment of the applicable standards or testing requirements. The risk of human error means that they could miss applicable standards and tests.

– The terms of service of the testing companies apply to all transactions between your company and them.

– We cannot guarantee that the testing companies have the capability to test according to all applicable regulations or standards.

Support

Support

risks Feature Information

+ You can ask general questions about the compliance process. We can also recommend service providers in our network. This includes testing companies and consultants.

  • Ask questions about information in generated compliance requirements lists
  • Ask questions about the general compliance process (e.g. lab testing and labelling)
  • Receive guidance to other official resources (e.g. government websites)
  • Request recommendations concerning testing companies, and other service providers

+ We can also help you fill templates, or review files created using the templates.

+ We can help you book third-party lab testing.

+ We can search for information in the sources and present our findings in a report.

risksLimitations and risks

– We do not offer legal advice, engineering/technical advice or confirm applicable regulations or standards for specific products.

– We cannot make our own interpretations, provide legal advice or approve/confirm products as fully compliant.

– We cannot guarantee that any answer we provide covers every single possible scenario or outcome.

– We can only compare reviewed files to a particular source. We do not take other sources into consideration.

– We do not ‘approve’ or ‘confirm’ labels, documents, certificates, or other files – including those generated using the templates. We cannot know that the information entered is accurate and correct.

– When we search source texts, we cannot guarantee that we have found everything that relates to the question or objective.

AI tool

CG AI 1

Information about risks can be found in Compliance Gate AI Tool White Paper > Risk Assessment.

Monthly updates

risks Feature Information

+ We review a set of official EU and US sources (see Monthly Review Methology) to monitor new and updated regulations and standards on a monthly basis.

+ We send a report each month summarizing our findings and specify if we deem it necessary to update the platform.

risksLimitations and risks

– We do not guarantee that all updates are made in real-time. There can be a delay from the implementation of new requirements until we have updated the platform.

– We do not guarantee that we ‘catch’ every single new or updated compliance requirement.