EU Chemical Regulations
EU PCN
According to Article 45 of the CLP Regulation, companies placing hazardous mixtures on the market are obliged to provide information about certain hazardous mixtures to the relevant national bodies. The national bodies make this information available to poison centres so that they can give advice to the citizens or medical personnel in the event of an emergency. Annex VIII to the CLP Regulation, adopted in March 2017, defines the harmonised requirements for poison centre notifications (PCN) applicable as of 1 January 2021. Let us help you through the process.
IUCLID
When you need IUCLID inputs, upgrades or TCC (Technical completeness checks) for EU or UK dossier submissions, Mallard Consulting Ltd can work efficiently and produce robust data sets in a cost effective way. Remember to plan in time for additional TCC work if your data set was last used on a previous version of IUCLID.
EU REACH
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerns the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in Europe. It was adopted to protect human health and the environment from potential risks that can be posed by chemicals.
REACH applies to all chemical substances and so has an impact on most companies across the EU and companies who export to or import into Europe and the burden of proof is placed on those companies.
To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.
Cosmetics
Cosmetics notification, safety assessments and environmental impact assessments. Under REGULATION (EC) No 1223/2009 of 30 November 2009, a cosmetic product must be notified and be safe for human health under normal use. Increasingly, the market sees environmental impact just as critically and opts to assess this in additional to human safety.
SCIP
Substances of concern in articles and complex products. Do you have an obligation to notify? Any supplier of an article containing a substance of very high concern (SVHC) on the Candidate List for Authorisation in a concentration above 0.1% weight by weight (w/w) on the EU market is required to submit information on that article to ECHA, as from 5 January 2021.
Biocides
Cosmetic or biocide? Reduce registration or full registration? Product type, active status... what are your obligations? Regulation (EU) No 528/2012 of 22 May 2012 must be complied with when bringing any biocidal product to the European Market.