By Paul Milne, Manager, Restricted Substances Testing Services, SGS and CHA 2013 Regulatory Resource
Having secured your commercial territory in North America, are you now looking to expand “across the pond”? To enter triumphant into the European Union? If so, be forewarned you’ll have shoals of chemical regulations around which it will be necessary to navigate. While nothing can replace an experienced pilot in these matters, “know before you go” is always a good idea.
You will first encounter REACH, the EU’s comprehensive policy regarding the manufacturing and importation of chemicals. This set of regulations has different requirements depending upon what you are bringing in and classifies chemicals as pure, mixed, or contained in an article. Determining which of these three describes your product is the first step, then figuring out how much you’ll be sending in is the second step because there are different registration requirements depending upon the tonnage being imported. Do your products contain any of the 138 chemicals on the list of Substances of Very High Concern? Chemicals on the Restricted Substances List (know formally as Annex XVII)? Compliance with US and Canadian regulations does not automatically confer acceptable status in the EU, as you may have guessed by now.
If your imports are classified as toys, then in addition to REACH you’ll have the European Toy Directive to consider. Do your toys contain dried powders intended to be released (paints, chalk)? Do your toys have a liquid component (finger paints, slime)? Due to the nature of these products (i.e. for children), there are more chemicals to keep track of, mainly soluble heavy metals. The limit for each metal is determined by how the toy is classified: the two above plus toys with scrapable surface coatings. Furthermore, a Chemical Safety Assessment will be required, but fortunately this is not so different from the review you will have had done for LHAMA.
Do any of your products rely on electricity for at least one intended function? Things like magnifying lamps, soldering irons, and sewing machines fall under the Restrictions of Hazardous Substances (RoHS). Simply put, every single component of one of these articles, from the outer casing to the tiny screw that holds the circuit board in place, cannot contain more than 1000 ppm of mercury, lead, hexavalent chromium (Cr+6), PBBs, or PBBDs, or 100 ppm of cadmium.
Your packaging will need to comply with the European packaging directive, known as Classification and Labeling of Packaging. This is exactly the same as the Toxics in Packaging Clearinghouse here in the US, but if you haven’t had to deal with that here, you will definitely need to check your packaging going into Europe. Simply put, there cannot be more than 100 ppm total of lead, mercury, cadmium, and hexavalent chromium in any packaging component, including inks. Packaging almost always ends up in landfills so this is the easiest way to avoid having these toxic substances end up in the environment.
These are the main regulatory hurdles facing businesses going into Europe. Please join me on March 13, 2013, for a webinar hosted by CHA where I will go into each of these in more detail. It is my hope that you will be better prepared to succeed in that market knowing the general shape of the chemical regulations you face over there. In the meantime, you can contact me at firstname.lastname@example.org if you have any questions. I confess, I may not be able to help with the paperwork, but as far as explaining what the chemical lists mean, I’ll give it a go.
Paul Milne is the Technical Manager for Restricted Substances Testing at the SGS Fairfield, NJ, location where he acts as the local expert for European REACH and RoHS, China RoHS, CPSC, Proposition 65, and FDA and EU Food-Contact regulations. He’s an active member of ASTM Committee F40; of AOAC, International; and a member of the American Chemical Society. Prior to SGS, Paul worked for Pepsi-Cola R&D where he developed analytical methods for testing ingredients and finished products, and evaluated new analytical technology for use in Pepsi’s global laboratory network. He holds a doctorate in analytical chemistry from the University of Michigan and a bachelor’s degree in chemistry from Cornell University.
Date: March 13, 2013
Time: 1:00 p.m. EST – 2:00 p.m. EST