Region Compliance
Sudarshan products comply with the following regional chemical regulations and guidelines.
Our Regulatory Focus
Europe REACH
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals
The REACH Regulation (EC) No 1907/2006 entered into force on 1st June 2007 to streamline and improve the former legislative framework for existing and new chemicals in the European Union (EU).
European Chemicals Agency (ECHA), an agency of the EU, implements the chemicals legislation to protect human health and environment, reduces the number of tests to be done on animals, while also enhancing the competitiveness of the EU chemical industry. It manages the registration, evaluation, authorization and restriction processes for chemical substances to ensure consistency across the countries in which REACH applies.
Sudarshan has successfully completed REACH registration of colorants, which are imported into European Economic Area (EEA) in quantities ≥ 1 tonne per annum at ECHA. Sudarshan is continually upgrading its REACH dossiers for new chemical and colorants.
European Chemical Agency (ECHA) has classified these C. I. Pigment as nanoparticles. At present, Sudarshan products are not intentionally manufactured at nanometric scale, containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for a minimum proportion of particles (50%) in the number size distribution, one or more external dimensions is in the size range 1-100 nm. We do not yet have respective analytical data and are currently generating those. Therefore, we can’t exclude that some of those products may have to be classified accordingly.
KKDIK (Turkey REACH)
On the 23th of June,2017, the Turkish Ministry of Environment and Urbanization (MoEU) announced Turkey KKDIK, regulation that was to be enforced from 23rd December, 2017.
The Turkey REACH like-law KKDIK is closely harmonized with the EU REACH provisions and requires companies to pre-register and register substances (on their own, in mixtures or in articles) manufactured in Turkey or imported into Turkey with volumes equal to or above 1 tonne per year.
Sudarshan has successfully completed pre-registration of our colorants. Sudarshan is continually upgrading its REACH dossier for new chemicals and colorants.
UK REACH
UK Registration, Evaluation, Authorization & restriction of Chemicals (REACH)
From the 1st of January 2021, the UK REACH regulation entered into force in Great Britain (England, Wales and Scotland). Therefore, GB based companies will need to comply with the UK REACH registration obligations for manufacturing and importing substances at 1 tonne per year or more, as such or as part of mixtures. Non-GB based manufacturing/formulating companies can register their substances via an Only Representative in the UK.
GB based companies that have registered their substances under EU REACH, have the possibility to grandfather these substances into the UK system. At the same time, UK downstream users/importers that rely on the registrations of their EU-REACH suppliers, can submit Downstream User Import Notifications - DUINs - for known substances to the UK designated authority. Sudarshan Chemical Industries has successfully completed Downstream User Import Notification (DUIN).
Application Specific Compliance
Additionally, our products generally comply with the following regulations/guidelines as applicable depending on the end application and the intended regions:
- Resolution AP (89)1
- IX. Colorants for Plastics and other Polymers Used in Commodities as of 01.06.2019
- Commission Regulation (EU) No 10/2011 of 14.01.2011 on plastic materials and articles intended to come into contact with food
- Circulaire No. 176 of 2 December 1959 on pigments and colorants intended for use in plastic materials and packaging as a reference text
- Safety of toys DIRECTIVE 2009/48/EC with the current version dated 21.05.2021
- ROHS EU directive 2015/863/EC (amendment of EU directive 2011/65/EC) on the restriction of the use of certain hazardous substances in electrical and electronic equipment
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 with current version 01.10.2021
- French Agency for Food, Environmental and Occupational Health & Safety's Decree 2012-232
- German Printing Ink Ordinance
- Nestle Guidance on food packaging requirements
- Swiss Ordinance (SR 817.023.21) 8124-5:2015