Before the United Nations developed the Global Harmonized System of Classification, there was no cohesive system to communicate chemical safety throughout the world, Erin Adams, authoring specialist at 3E, told attendees of the NAFFS 99th Annual Convention. “One country would say a certain chemical was safe while another would say it was toxic,” she said. “The UN decided there was a need for concrete ways to test chemicals and set limits to determine if something is hazardous or not. The word ‘harmonize’ means to bring into harmony, accord or agreement. The UN hit the mark when they harmonized how you determine whether the chemical is hazardous or not. Where things went a little awry is when they said you can adopt it when you want within certain limits.”
The UN revises its book of standards every two years, noted Adams. As different countries around the world have adopted the GHS system, they’ve adopted different provisions of the GHS purple book. Pointing to a chart, Adams noted Canada adopted the third revision for their classification of SDSs. The EU was an early adopter. They are currently on their fourth revision and working on the fifth for 2018. “The significance of all these revisions,” she told attendees, “means things are always changing for your labels.”
Focusing on North America, Adams said, “You might think that we’re all on one continent so things will be continuous. However, when they adopted GHS, they let countries decide which building blocks to adopt.” Fortunately, there are many in common. However, the chart depicts the orange/yellow blocks that Mexico adopted but Canada and the U.S. did not. Referencing the aquatic and environmental hazards at the bottom, Adams said those are all non-mandatory for every country in North America. “You can add them; you can state the hazard but it is not a requirement.”
In addition to building blocks and revisions, Adams detailed other variations that are allowed. The U.S. determined there are certain statements it would like to change a little. The exact wording of the statement has to be specific. H statements are hazard statements and P statements are precautionary statements. As an example, the H statements can tell you something is corrosive while the P statements tell you where it was. “There were other things added as well,” she said. “Historically the U.S. and Canada use additional classifications that are not covered by GHS, such as combustible dusts. Mexico did not add those to their adoption of GHS but we have taken the approach of keeping those on Mexican documents because they are not disallowed and it makes it a little more continuous between the three countries,” said Adams.
Europe, Adams said, was an early adopter. Pointing out the differences of various countries, Adams noted no single SDS or label can be used globally. Category 4 was adopted by every country in North America but was not adopted in Europe. “They don’t recognize Category 4, which is combustible liquids. Also when it comes to eye damage and irritation, the EU doesn’t differentiate between 2A and 2B (one is worse than the other). They just use a Category 2. However, the U.S. requires you to differentiate if that information is available.
“Turkey has a requirement that a nationally certified preparer has to certify your SDS document in order for it to be a legal document,” said Adams. “If you don’t have that, it’s not a recognized document.”
Adams said the differing definitions create challenges. “Classification of your product is one for starters. Add to that SDS requirements and label requirements,” said Adams. “Regarding classification, there are different versions of GHS requirements that have been adopted. There are building blocks that have been adopted. Then there are mandatory classification lists.” She asked audience members if they were familiar with the EU Annex 6. “A lot of people go to this because the EU was an early adopter; it’s online; it’s accessible and it’s free,” said Adams. Notably the EU has about 4,500 substances on the list. But China that came out with the SAWS list last year which has 3,300 substances. But sometimes the classifications don’t match. Then there are advisory lists (which aren’t mandatory) and industry-specific lists, such as IFRA. “You need to be careful if you are just trying to quickly get a classification because some of the information is not the most reliable information,” said Adams.
“You may be familiar with the IFRA lists that have been put out as far as classifications,” said Adams. “Those are to standardize within the industry so that we are all speaking the same language and identifying that this is hazardous and this is not. Then within all of that there are mixtures with certain percentages of something. The cutoff limit is what tells you the classification.” Adams used skin sensitization as an example because she finds commonalities there between the flavor and fragrance industries. Naturally occurring materials have a lot of skin sensitization occurrences and there are levels of what is safe or not safe.
“With regard to skin sensitization, some of the natural products in the food and fragrance industries can cause sensitization problems,” said Adams. “And this is very complex in the way that countries have decided to adopt it. You need to look at cutoff limits to know whether to classify it or not. Category 1A is typically where there is more evidence of lots of human skin sensitization cases. Category 1B is when there are definitely animal cases where they’ve proven sensitization in tests and there are a few cases of human sensitization but not enough to warn at 1A. The EU meant well but it definitely complicates things. The EU and a few other countries require disclosure of the materials that are in there as skin sensitizers.” She noted concentration limits in Annex 6 are unique and are not recognized by other countries. She urged caution when using those because one needs to watch out for the specific concentration limits.
“The same formula from three different countries can get you three separate classifications without changing anything in the formula,” said Adams. “When you are using Annex 6, watch out for specific concentration limits because other countries don’t recognize that. The EU may consider something hazardous but only at a greater percentage. Referencing a chart using four skin-sensitizing materials: vanilla extract, D-limonene, sandalwood oil and beta-caryophyllene, Adams noted that three of them had a skin sensitization Class of SS1 and one had a class of SS1A. The total percentage of skin sensitizers in that formulation was 0.98 percent. “What does that mean? It means it’s classified as a skin sensitizer in the U.S. and China. However, within the EU it is not a sensitizer because it is less than 1 percent. The correct EUH208 statement for this formula: ‘EUH208 – Contains Vanilla Extract, D-limonene, Sandalwood Oil, Beta-Caryophyllene. May produce an allergic reaction.’” So whether a chemical is natural or not natural, the point here is safety, stressed Adams.
Adams said it’s necessary to produce a safety data sheet that correctly applies those classifications. The template layout is the first hurdle. Each country chooses its own header or whether it wants sub-sections or section numbering, etc. H & P (Hazard and Precautionary) Statements also need to be displayed in different ways based on the country. Once you have a valid SDS for your country, what challenges will come with labels?
Countries have different requirements for minimum label information. Showing an example from the U.S., Adams explained the label must include a product identifier; a signal word (warning); hazardous statement(s) – (Note: the U.S. allows them in paragraph format); pictogram(s); precautionary statement(s); and name, address and telephone number of the chemical manufacturer, importer or other responsible party. And you must have a red border label for any label that goes out of house. OSHA does allow for a black border label on SDSs and on secondary containers only in the manufacturing process.
Other labeling challenges include the wide variety of symbol sizes required by different countries. The U.S. does not have specific size requirements but requires it be proportional to other label elements. Mexico’s standard is “based on distance for observation according to Table B.2.”
Other challenges include requirements to remove one or more pictograms. An example from an EU guidance notes:
Font size requirements vary from country to country. Other challenges include the requirement by some countries to require H&P codes to print on the label while others limit the number of P statements to just six which must match the SDS. In the U.S. no P Statement reduction is required; consolidation is allowed.
When it comes to listing ingredients, “Contains” is not required for the following authorities/regions: Canada, Caribbean/ Central America, Indonesia, Korea, Malaysia, Mexico, Singapore or the U.S.
Adams detailed the many challenges with small packaging. So what is the definition of a small package? It is undefined in the U.S., Japan, Australia, Thailand and Vietnam. In Canada, China, Korea and Taiwan, it is defined as = 100mL and in the EU, Malaysia and Singapore, it is defined as = 125mL. Some places have exemptions. However, the U.S. is not one of them.
OSHA has issued multiple letters of interpretation stating there are very few exceptions for labeling small packages. From NIST LOI:
o Product identifier
o Appropriate pictograms
o Manufacturer’s name and phone number
o Signal word
o A statement indicating the full label information for the chemical is provided on the outside package.
o All the applicable label elements, as defined in 29 CFR 1910.1200(f)(1).
o The outside package must be clearly marked to ensure the complete label elements are visible and it must clearly inform users that the small container must be stored in the outer container bearing the complete label. The complete label must be maintained on the outer package (e.g., not torn, defaced, destroyed).
How does one manage all these labeling requirements? “You can print labels in house or you can preprint them with the red boxes or you can buy a new printer with red ink,” Adams said. If you buy them preprinted, Adams warned blank boxes are not permitted. “OSHA has specifically stated multiple times no blank boxes,” said Adams. “You have to black them out entirely.”
When looking for an authoring platform to do SDSs, labels or both, Adams suggested asking these important questions:
Once you have an authoring system, how can you get the most out of it?
“The best piece of advice I can leave you with is to make sure your ingredients match what your suppliers are giving you,” said Adams. “Remember – good information in means good information out.”