Spotlight on Regulatory Updates
What You Need to Know
H2 Compliance announces New Subsidiary in the USA
As part of the increased internationalisation and expansion of H2 Compliances we are pleased to announce the opening of our New Subsidiary in the United States of America, H2 Compliance Inc. Allow me to introduce H2 Compliance Inc., a new wholly owned USA subsidiary of H2 Compliance Ireland, which will deliver regulatory compliance services in...
Chemical registration- 2013 duties under REACH
If you have chemical registration 2013 duties under REACH, then you need to know what you should be doing and by when. When talking about the need to register, attention generally focuses on the need for data review, new testing, deciding on classification and filling in all those fields in IUCLID. Even when considering the...
CLP-The European format of GHS
Classification, Labelling and Packaging (CLP, legislation 1272/2008/EU) is the EU’s adoption of the UN GHS. It is a chemical regulation that seeks to protect human health, ecosystems and the environment whilst maintaining worldwide trade. Background to harmonisation of world chemical regulation Awareness existed that different countries classified the same chemical in different ways. These differences...
EU Regulations for Ink Printing. What is your legal status?
Switzerland introduced a positive list in 2010 (Swiss ordinance for printing inks SR 817.023.21) of all substances allowed in the manufacturing of printing inks for food contact packaging. The question arose, what is the legal situation of these materials within EU Member States? Up to now, no specific EU harmonised legislation on printing inks for...
REACH Registration Dossier:What’s in a Public Name?
In previous blogs we have discussed confidentiality and dissemination of registration dossiers. This blog will continue on that theme and focus on confidentiality claims of the IUPAC name and what is a public name under REACH. Does your substance qualify for confidentiality of its IUPAC name? In accordance with REACH Article 119 (Electronic Public Access)...
How do toxicologists assess a substance’s behaviour in water
The purpose of this communication is to address how substances are classified for effects in the aquatic environment. The first step in building a registration dossier (to fulfil the ‘R’ part of REACH) is to carry out lab testing on the substance in a GLP environment. Annex VII of REACH lists the twenty two lab...
REACH-Why do you need an Only Representative?
This is a question that all non-EU manufacturers and formulators will ask themselves before appointing an Only Representative. While the benefits of appointing an Only Representative will be discussed here at a later date, this article will focus on the factors and scenarios that would result in the need for an Only Representative to be...
The Recast of the RoHS Directive and what it means for you
On 1 July 2006, the EU implemented Directive 2002/95/EC restricting the use of lead, cadmium, hexavalent chromium, mercury, polybrominated biphenyls (PBB) and polybrominated diphenylethers (PBDE) for electronic and electrical equipment sold in the EU. This legislation led to enormous changes in the technology with which electronic and electrical equipment was produced. It also led to...
REACH Next Enforcement Targets:Non-EU companies take note!
Ramped up enforcement is planned for EU Importers around REACH registrations and Only Representative as part of the Ref-3 Enforcement Project. Plus increased assessment and scrutiny of reduced registration dossier for intermediates is in full swing and will eventually include completion of on-site assessments by Member States. Ref-3 is the third in a series of...
EU REACH REGISTRATION: Size is everything
There are 20 million Small and Medium Size Enterprises (“SMEs”) in the EU representing 99% of the total number of businesses. To ensure that this important sector is not unduly burdened by REACH, certain costs are reduced. Most notable is the cost for submission of jointly submitted Registration Dossiers to ECHA. Costs are reduced 30%,...
REACH Only Representative Supply Chain Communication
Communication with your upstream suppliers and your downstream customers is a very important aspect of the REACH programme regardless of your status under REACH. For non-EU suppliers who have appointed an Only Representative, they should use their OR to guide them through the quagmire of upstream and downstream communications. Upstream Communications: This can encompass two...
IUCLID upgrade allows ECHA to increase information dissemination
Are you confused by what is meant by dissemination of Safety Data Sheet information and confidentiality claims? If so, I bet you are not alone. The recent upgrade to IUCLID 5.4 with the corresponding new version of REACH IT will allow ECHA to increase the amount of information currently available to the public from REACH...