Customized Assessment
We will evaluate your product portfolio to uncover any regulatory list requirements, keeping you ahead of your compliance obligations.
Seamless Regulated List Tracking
Unlock the Power of Regulatory List Tracking for Uninterrupted Compliance
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Regulatory
ExpertiseWe help you identify substances of concern, conduct impact assessments, and prioritize action plans, so you can create a streamlined process for tracking restricted substances and preventing potential risks.
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Comprehensive
SupportWe can further support in handling your SCIP notifications, product registrations, and in performing exposure and toxicology risk assessments to inform labeling decisions, such as for Prop 65 compliance.
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Compliance
SoftwareUse our bespoke Element1 platform modules to store product data, track restricted substances, visualize risks, and quickly evaluate product compliance to maintain long-term market access and business success.
Tracking Hazardous Substance Regulations
Explore the complexities of the myriad of regulatory substance lists.
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Various Regulatory Lists & Restrictions
- EU REACH Regulatory Lists: Key lists include the Annex XVII Restricted Substances List, Annex XIV Authorisation List, and Substances of Very High Concern (SVHC) Candidate List for Authorisation, which highlight substances under current regulatory risk management actions.
- Early Warning Lists: Lists like the RMOA, ROI Restriction, and ROI SVHC provide insight into substances proposed for future regulation, offering advanced notice of potential changes.
- US Restricted Substances Lists: Includes the California Proposition 65 List, PBT chemicals under the EPA’s TSCA, and substances identified for risk evaluation under TSCA.
- Global Regulatory Lists: The Persistent Organic Pollutants (POPs) List under the Stockholm Convention restricts hazardous chemicals globally.
- Industry-Specific Restrictions: Sectors like textiles and toys have their own unique substance restrictions and regulatory requirements.
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Scope
- Across different industries and regions, numerous lists regulate substances or chemicals that pose risks to human health, safety, or the environment. These lists help governments, industries, and businesses to monitor hazardous substances, enforce safety standards, promote transparency, and support product compliance.
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Requirements
- Monitoring these regulatory lists helps companies anticipate new restrictions and take proactive measures, such as substituting or eliminating hazardous chemicals, to stay ahead of future regulatory requirements.
Our Unique Regulatory Tracking Solutions
Personalized Guidance
Our team will guide you with cost-effective solutions to stay compliant with all regulatory lists and handle all your documentation and notification needs.
Continual Support
As regulatory lists evolve, we offer ongoing support for tracking controlled substances, all streamlined through our Element 1 platform.
Meet Our Regulated Substances List Tracking Expert
Dedicated professionals guiding your compliance journey.
Miriam McAuliffe |MSc|
Service Manager
Dublin, Ireland
Frequently Asked Questions
- The main regulatory actions under REACH are Authorization or Restriction, but other actions outside REACH may be taken if more suitable.
- The process starts with the CoRAP (Community Rolling Action Plan) list, where substances are selected based on a risk-based screening that considers hazard information, exposure data based on uses, and total registered volumes.
- If after screening and evaluation, a substance is flagged as a concern, it enters the Regulatory Management Option Analysis (RMOA) process to determine if regulatory action is necessary and to identify the most appropriate measure, such as a REACH restriction, authorization, or alternative regulatory actions like a binding OEL or harmonized classification.
- The process for a substance to move from evaluation to inclusion in the authorization or restriction list takes several years, involving thorough assessments.
- If regulatory action (restriction or SVHC identification) is recommended after the Regulatory Management Option Analysis (RMOA), the substance must first be listed in the Registry of Intentions (ROI), and for authorization, it must pass through the SVHC/ candidate list and the recommendation for inclusion in the authorization list.
- Early warning through ROI lists gives companies time to plan for substitution, which, according to an ECHA survey, can take over 7 years, highlighting the importance of starting substitution efforts early in the process. Companies facing technical barriers to substitution should track substances on early warning lists, such as RMOA, to ensure they have enough time to implement alternatives.
- Authorisation under REACH is designed to control the risks of Substances of Very High Concern (SVHCs) throughout their lifecycle, targeting substances like carcinogens, mutagens, reproductive toxins (CMRs), PBTs, vPvBs, and endocrine disruptors.
- Once an SVHC is added to the Authorisation List, its use and market placement are prohibited after the sunset date, unless the company has obtained authorization, which requires a detailed application process that can take up to 4 years (including the 2-year application review and 2 years for approval). Authorisations need to be refreshed between 4-12 years depending on the expiry date, with the expectation the substance will eventually need to be substituted. There are some generic exemptions to authorisation, that will apply to all substances on the list.
- Restrictions apply to hazardous substances based on use and exposure risks, potentially prohibiting their manufacture, use, or market placement in certain applications, with broad restrictions potentially having a wider impact than authorization; some restrictions have generic exemptions such as SR&D, but each has specific derogations based on its scope.