Magnesium and calcium stearate - BSE, "GM", organic solvent, irradiation, allergen and erucic acid status
Some JMB stearates are used in the production of both pharmaceutical and confectionery products and, in the light of the controversy regarding BSE and the use of genetically-modified materials, many customers have contacted us regarding the status of our products. There has also been recent interest in reducing or eliminating the levels of organic solvents present in pharmaceuticals and whether our products have been irradiated. EU legislation requiring allergen labelling has led to customers contacting us for information. Lastly, the EU has recently established legislation covering erucic acid in foodstuffs.
We hope that this position paper gives all the information required, but please feel free to contact us if you need any further help. A signed copy of this statement can be downloaded here.
For many years, all stearates manufactured by JMB have used stearic acid derived exclusively from plant sources - specifically, the oil palm. We neither use nor store stearic acid acid from any other source on our site.
There is, therefore, no possible risk of any potentially-infectious material being present in any of our stearates.
To the best of our knowledge there has not yet been, and there are no plans for, any experimentation on modifying the genetic make-up of the oil palm. As all the other raw materials used in the manufacture of our stearates are of inorganic origin, there are no "GM" materials present in them.
The International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) produced its document "Impurities : guidelines for residual solvents" which divided a number of organic solvents which might be present in pharmaceuticals into three classes:
Class 1 - solvents that should be avoided
Class 2 - solvents to be limited
Class 3 - solvents with low toxic potential
We are pleased to be able to confirm that no organic solvents are used in the production of the stearic acid we use or in the stearate manufacturing process at JMB. We can therefore confirm that JMB stearates are solvent-free.
No JMB stearates are subject to irradiation and none of the manufacturers of the stearic acid we use for its production themselves use irradiation.
Allergens - Directives 2006/142/EC, 2003/89/EC and 2000/134/EC
Directive 2003/89/EC amends 2000/13/EC and requires, amongst other things, that food products be labelled if they contain any of the allergens listed in Annex IIIa. After 25th November 2005 it becomes unlawful to sell products which do not comply with the Directive. Directive 2006/142/EC further amends 2000/12/EC to add lupins and molluscs to the allergens which have to be declared. We can supply a copy of any of the Directives in electronic form on request.
We can confirm that no JMB stearate contains any of the allergens mentioned in the updated Annex IIIa list: these are as follows:
- cereals containing gluten (ie wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof
- crustaceans and products thereof
- eggs and products thereof
- fish and products thereof
- peanuts and products thereof
- soybeans and products thereof
- milk and products thereof (including lactose)
- nuts ie almonds, hazelnuts, walnuts, cashews, pecan, brazil, pistachio, macadamia, Queensland and products thereof
- celery and products thereof
- mustard and products thereof
- sesame seeds and products thereof
- sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre (expressed as SO2)
- lupins (added by 2006/12/EC)
- molluscs (added by 2006/12/EC)
Recently-published EU Regulation 696/2014 set limits for the maximum levels of erucic acid permitted in oils and fats and foods containing oils and fats. Although stearates don't fall into the category 'oils and fats', we thought it wise to investigate the matter. We have been advised by our stearic acid suppliers that erucic acd is not present in their material and there are no concerns about this substance.
Please note that this statement does not apply to Zinc Stearate.