General information
Regular toothpaste for adults and children.
Every manufacturer has its own formulation for toothpaste. It is therefore impossible to give a standard formulation. The information given here should serve as a guideline for purchasers.
Information on the toothpaste components:
- Humectant: The concentration of humectant will depend on the type of formulation (paste or gel). To obtain a gel type formulation a higher level of humectant including a minimum level of glycerin is normally required. The total quantity of humectant is usually selected to give the final formulation a" water activity" level that makes it bacteriostatic. For availability, cost, or formulation reasons, glycerin may be preferred to sorbitol and vice versa.
- Abrasive agent: Chalk is rather more abrasive than other materials. It may be considered too abrasive. Abrasive silica or specifically DCPD (dicalcium phosphate dihydrate) could be preferable. For availability or cost reasons chalk may be preferred.
- Thickening agent: Not used with chalk.
- Gelling agent: SCMC (Sodium Carboxy Methyl Cellulose) is often preferred for cost reasons. Xanthan gum is usually more costly and bacteriologically more risky. Some products may be formulated with carrageenan gum. The rheological properties of products are dependent on the type of gelling agent used in the formulation.
- Detergent: For cost and availability reasons and also because of regulations SLS (Sodium lauryl sulfate) is often selected. It gives a soapy taste that is normally covered by the use of a flavour associated with a sweetener. Gives foaming and should be adjusted according to local taste and formulation type.
- Flavour: Key, rather expensive component that is often the number one product preference parameter. Depending on flavour type and strength. Mint is often the flavor of choice (peppermint or spearmint) but other types of flavors are also used (fruity, liquorice, medicinal taste etc.). Peppermint will give a strong flavour whereas spearmint will give a mild flavour generally more acceptable and usually preferred by children.
- Sweetener: Key to improve taste during use. Usually sodium saccharin. Can be sodium cyclamate or acesulfame K.
- Colorants: Watch local regulations for positive and negative lists regarding foodstuff.
- Anti-caries agent: Regulations may require lower concentrations for children (usually 1000 ppm maximum). According to local regulations. Normally 1450 ppm of fluoride ion or less.
- Option of non-fluoride toothpaste is acceptable.
- Preservatives: Watch local regulations for positive and negative lists regarding foodstuff.
- Buffering agents: Watch local regulations for positive and negative lists regarding foodstuff. Buffering agents are particularly important to avoid corrosion problems if aluminium tubes are used. With laminate tubes, widely used nowadays this is less crucial but high acidity or alcaliny may anyhow impact flavour taste.
- Additives and other ingredients: Watch local regulations for positive and negative lists regarding foodstuff.
- Other active ingredients (therapeutic): Watch local regulations for positive and negative lists.
- Water: The microbiological quality of the formulation water must be "food grade" as for all other ingredients in the toothpaste. The % of formulation water can vary significantly in quantity depending on the type of formulation as the residual water coming from the other raw materials can be quite different from formulation to formulation and will therefore have an important impact.
The complete list of ingredients should be specified by the supplier with characteristics, as well as the raw materials specification, the materials and production process traceability, and the quality assurance process.
Potential suppliers should be requested to provide their own products formulations and specifications including packaging. This should help evaluate their capability, the quality level of their products, and the professionalism of their operations.
Some specifications may vary to meet national standards and local market conditions. For locally sourced items, it is a prerequisite to check the relevant national regulations or specifications. Any important variation from the EIC standard needs to be approved by a specialist.
Specifications
Regular tooth paste for adults and children.
The product must be safe under normal conditions of use.
All ingredients in the toothpaste must be food grade.
Product Ingredients |
Mini/Maxi |
Humectant: Sorbitol or glycerin or combination of both |
Minimum 28% pure sorbitol or
24% pure glycerin |
Abrasive agent (Abrasive silica, Dicalcium phosphate, chalk etc.) |
according to formulation |
Thickening agent (thickening silica or else) |
according to formulation |
Gelling agent (SCMC or xantham gum or else) |
according to formulation |
Detergent (Sodium lauryl sulphate SLS, or Sodium N-Lauroyl sarcosinate, or else) |
according to formulation |
Flavour |
according to formulation |
Saccharine (sweetener) |
according to formulation |
Colourants |
according to formulation |
Anticary agent (Sodium fluoride or Sodium monofluorophosphate or Stannous fluoride).
It is mandatory to check the content. Product should not be released if out of specification. |
Maximum 1450 ppm Fluoride ion for adults and 1000 Fluoride ion ppm for children |
Preservatives |
according to formulation |
Buffering |
according to formulation |
Additives and other ingredients (titanium dioxyde, PEG-polyethylene glycol, for example) |
according to formulation |
Other active ingredients |
according to formulation |
Demineralised bacteriologically clean water |
by difference to 100 % |
Product parameters |
|
Organoleptic
|
To match agreed standard sample, as provided as part of the contract, and pre-defined with customer. |
Physico-chemical
|
Values with measuring units, conditions and method of analysis to be obtained from supplier as part of the contract. |
Micro-biological |
Analytical methods should be defined and agreed in contract. |
Bacteria, Fungi/moulds, Yeasts: |
No pathogens and less than 20 colony-forming units (CFU) per ml. |
Result of challenge test to be supplied for: |
Staphiloccus Aureus, Pseudomonas aeruginosa, Candida albicans, Escherichia Coli. |
Packaging |
|
Primary pack |
Tamper-proof sealed “plastic/aluminium laminated tube” or “folded aluminium tube” of 75ml equivalent approximatively to 100g of product, as mentioned in contract, with cap. The tube can be packed in an individual carton box closed with an adhesive seal. |
Marking on primary pack |
Clear and durable marking with: product name, manufactured by: name and address, country of origin, list of ingredients, net volume, expiry date and batch number. |
Secondary pack |
Export cardboard box 5 plies, with 144 tubes. Closed with long lasting tape or glued flaps. Box size to be tightly adjusted to content. Marking as per specified in contract. |
Transport packing |
Pallets of n boxes, with shrink-wrapped plastic film. Pallet type and size as mentioned in contract. Supplier to indicate the pallet pattern and number of boxes per pallet as part of the contract. |