Prisma Group Liquid Dispersions

What regulatory changes have recently hit the industry?

With the formulation of bespoke products for a wide range of industries and global applications, it is paramount that we are aware of the growing amount of regulatory changes that are introduced.

We work with our customers to design products to their exact specifications and have to ensure we comply with regulation changes in all our industries, such as:

– Consumer goods
– Food packaging materials 
 Toys
– Pharmacopoeia

 

Reasons for increased regulation requirements:
 
  • Government pressure – new laws are being passed that emphasise protection of the economy, society and environment.
 
  • Public awareness – societal views voicing concerns and driving change.
 
  • Regional Restrictions – As more countries develop into the industry, more regional restrictions are being implemented (i.e EU, FDA, MERCOSUR, REACH CHINA).
What regulation changes have hit the industry recently?
 

Reclassification of Titanium Dioxide (Tio2)

Commission Regulation (EU) 2022/63 of 14 January 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the food additive titanium dioxide (E 171)
 

-The above amendment relates specifically to the use of food additive of (Tio2).

-However, there is no documented change in the use of Tio2 in a direct or indirect food contact application, with ECHA and Regulation (EU) No 10/2011 Annex I show Tio2 CAS 13463-67-7 as a Food Contact Material.

-As a result, our products comply with Commission Regulation (EU) 2022/63 of titanium dioxide as a food contact material in plastic.

-The research is based on the EFSA study including the accumulation of TiO2 nanoparticles, please see below statement from our supplier in regards to titanium dioxide nanoparticles:

 

Commission Delegated Regulation (EU) 2020/217, published in the Official Journal of the EU on 18 February 2020, introduced harmonized classification of titanium dioxide (CAS 13463-67-7, EINECS 236-675-5) as suspected of causing cancer by inhalation, i.e. category 2 carcinogen, if it comes in the form of a powder containing min. 1% of particles with aerodynamic diameter equal to or below 10 µm.

The only applicable technical standard for determining the percentage of the above particles with a pan-European scope is the European standard EN 15051 for measuring the dustiness of bulk materials.

The most suitable method for the determination of dustiness itself is described in part EN 15051-2, i.e. the rotating drum method.

Food Contact Applications

 
For product markets in Europe there are a number of applicable regulations, including:
 
  • 2020/1245/EC amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
  • European Resolution AP (89) 1
  • BfR Recommendation IX
  • Allergens – Annex II of Regulation (EU) No 1169/2011
 
-For supply into the USA, both FDA regulations and the California Proposition, list 65 safe drinking water and toxic enforcement act of 1986 require due consideration for different applications.
 

 

Japanese positive list for utensils, containers and packaging

 

-Japan’s ministry of Health, Labour and Welare (MHLW) revised specifcations and standards for foods and food additives (April 28,2020).

-This amendment introduces the positive list system for sythentic resins and additives used in food contact applications for food utensils, Containers and packaging (UCP), with implementation 1 June 2020 and end of transition measures 31st May 2025.

 

 

Restricted Use and Hazardous Substances

In addition, there are numerous other regulations that restrict the use of materials in certain applications or require exceptions. We are able to work with customers to fulfil their requirements and provide statements covering these regulations, including:
 
 
  • 2020/1245/EC amending and correcting Regulation (EU) No 10/2011
  • REACH-Regulation (EC) 1907/2006 dangerous substances
  • REACH-Regulation (EC) 1906/2006 Substances of Very High Concern (SVHC)
  • RoHS
  • REGULATION (EC) No 1005/2009 substances that deplete the ozone layer
  • EC 1895/2005 epoxy derivatives
  • Regulation (EC) No 850/2004 persistent organic pollutants
  • Directive 94/62/EC & CONEG toxics in packaging legislation
  • Endocrine Disruptors
  • Phthalate plasticisers, Silicones, Latex & Azo dyes
 
-Product specific Material Safety Data Sheets (MSDS’s) & Technical Data Sheets (TDS’s) and Declaration of Compliance (DoC’s) are available on request
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Ensuring safe use and full compliance
 

-It’s important to note that to prove freedom from migration and ensure conformity with full legal requirements, testing is often required on the particular end-use application.

-Testing in certain stimulants under given conditions should be similar to those used in end-applications, paying particular attention to fact individual colourants or additives may have a different profile in a test piece than when in actual end component /article.

-At Prisma we consider all considerations from regulations statements, supplier statements and internal testing results to ensure that customer products are regulation compliant and provide safe use in final products.

 
In other news…
 

K Fair preparation has begun! We will be presenting in Dusseldorf from the 19th-26th October.

We’re joining Knowde! Knowde is the marketplace for ingredients, polymers and chemistry. Making it that step easier for customers to get the products they need!

We’ve been named as a finalist at the Plastic Industry Awards! Our response to the global pandemic and the measures we put in place have led us to the 21st Plastic Industry awards.

The Prisma Group Sample Wallet The Perfect Match For Your Business

To see how we can be the perfect match for your business, contact us today for a free consultation on +44 (0) 1457 856 505 and discover how we can be of service!