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RINA Jon Savage 

 

Steven Lewis

UK Materials, Technology & Innovation Business Developer

Understanding how new obligations apply to your business and what action to take as a result is crucial

RINA Product Regulatory Compliance

Chemical Regulatory Compliance means legal compliance with substance restrictions, enforced obsolescence, safe use of chemicals, ecodesign, responsible sourcing and supply chain management. 

Manufacturers and their supply chains face ever-growing, complex and frequent changes to regulatory and end-client requirements concerning energy consumption, material choices and chemical substance use, responsible sourcing and durability/recyclability which can directly impact product design and drastically affect costs and delivery. 

Chemical compliance requirements include: 

How can we help with Chemical Regulatory Compliance? 

Understanding how new obligations apply to your business and what action to take as a result is crucial.

We help industry to comply with emerging requirements, built on our expertise from a range of industries and scientific and engineering disciplines.

We also work for key stakeholders involved in the development and implementation of environmental product policy, including the European Commission and UK government.

As such, we have a detailed, current knowledge of status and interpretations in the EU and worldwide. 

Our services include: 

 

Frequently Asked Questions (FAQs)  

The following is a non-exhaustive list of legal requirements applicable to certain products and substances/mixtures in certain applications. Showing compliance is often through the use of appropriate standards which are not listed. This list focuses on EU requirements but somewhat analogous requirements often exist in other jurisdictions. In general, UK requirements remain largely aligned with those in the EI but there are significant differences and divergence over time is to be expected. 

Type Title of legislation Ref. Jurisdiction
Chemical/ environmental Restriction of certain Hazardous Substances (RoHS) Directive 2011/65/EU EU/EEA
 Chemical/ environmental REACH Regulation   1907/2006 EU/EEA 
 Chemical/ environmental Food Contact Materials Regulation   1935/2004 amended by 2019/1381  EU/EEA
Chemical/ environmental  Stockholm Convention    International 
 Chemical/ environmental Toxic Substances Control Act (TSCA)    US Federal 
Chemical/ environmental   Batteries Directive 2006/66/EC amended by 2013/56/EU   EU/EEA
 Chemical/ environmental Ecodesign (Framework) Directive – and implanting regulations   2009/125/EC  EU/EEA
 Chemical/ environmental Classification, Labelling and Packaging Regulation (CLP)   1272/2008  EU/EEA
 Chemical/ environmental Biocidal Products Regulation   528/2012  EU/EEA
 Chemical/ environmental  The Fluorinated Greenhouse Gases (F-Gas) Regulation  517/2014 EU/EEA 
 Chemical/ environmental  The Persistent Organic Pollutants (POPs) Regulation  2019/1021 EU/EEA 
 Chemical/ environmental  Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/EU   EU/EEA
 Chemical/ environmental  Proposition 65    California
Chemical/ environmental   Waste Framework Directive - SCIP    EU/EEA
 Both Toy Safety Directive  2009/48/EC   EU/EEA
 Technical  Low Voltage Directive (LVD)  2014/35/EU  EU/EEA
 Technical  Radio Equipment Directive (RED) 2014/53/EU   EU/EEA
 Technical  Electromagnetic Compatibility (EMC) Directive  2014/30/EU  EU/EEA
 Technical  Pressure Equipment Directive (PED)  2014/68/EU EU/EEA
 Technical Simple Pressure Vessels Directive  2014/29/EU  EU/EEA 
 Technical  Personal protective equipment (PPE) Regulation  2016/425  EU/EEA
 Technical  Equipment for potentially explosive atmospheres (ATEX)  2014/34/EU EU/EEA 
Technical   Machinery Directive  2006/42/EC  EU/EEA

- Understanding requirements that apply to a particular type of product placed on the market in a certain jurisdiction – and what to do as a result 

- Keeping up to date with changes in existing requirements and emerging new ones. Understanding how to respond. 

- Understanding upcoming obsolescence issues caused by restriction of chemical substances (e.g. RoHS, REACH, TSCA) and avoiding regrettable substitution.  

- Assessing presence of Substances of Very High Concern (SVHC) in products and components. 

- Eco-design and sustainability 

- Chemical content testing or technical analysis 

- Understanding end-of-life obligations (e.g. WEEE, batteries) 

- Demonstrating conformity 

- Assessing safety/risk 

- Responsible sourcing (conflict minerals)  

Ensuring that a product conforms with all relevant requirements when placing it on the market in any jurisdiction is crucial to ensure market access in any country. Understanding what requirements apply, how to address them, and what processes and evidence is needed to support this is key to minimising business risk. The earlier these issues can be addressed in the design process the easier it is to design these out or account for them.  

- Obsolescence/phasing out of hazardous substances. More and more substances are either being made subject to restriction nor at least being made reportable particularly driven by EU and US legislation. Current examples of substances being considered for further measures include lead metal and per- and poly-fluoroalkyl substances (PFAS). 

- Widening product scope and tightening of requirements. Examples being considered currently include batteries (improved performance, removability and replaceability, labelling, introducing conformity assessment, more substance restrictions, labelling), lower limits for off mode power usage and efficiency underload for a range of products, EU Product Safety Regulation - proposed to replace the General Product Safety Directive (GPSD).  
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