Do you feel like banging your head when ensuring your products are complaint? Tired of researching? Has a formula been approved to only find out it has a restricted component? Guidelines and Restrictions Module is the answer to your woes!
Guidelines and Restrictions Module is used for:
- Ingredient restrictions by country and/or jurisdiction for specific products/categories and usages.
- Product specific restrictions by country and/or jurisdiction or customer.
- Product restrictions by jurisdiction by product type.
For example, let’s look at Salicylic Acid CAS 69-72-7. Salicylic Acid has many functions in the personal care industry. It has been used as an exfoliant and to improve the appearance of pores. It has been used as a natural occurring preservative system. Salicylic Acid is also an active ingredient in the treatment of acne, dandruff, psoriasis, wart removal, corns, and calluses. The following Regulatory bodies, European Union, Canada, and United States, have various regulatory needs that need to be met.
- In the European Union Salicylic Acid can be used at a maximum concentration of 3.0% in rinse-off hair products. For other products not including body lotion, eye shadow, mascara, eyeliner, lipstick, and roll-on deodorant a maximum concentration of 2.0% is allowed. Products which contain Salicylic Acid and could be used in a children’s ages 3 and under required a warning on the label. “Not to be used for Children under 3 years of age.”
- In Canada Salicylic Acid can be used at a maximum concentration of 2.0% per the Canadian Hot List.
- In the United States Salicylic Acid can be used as an acne active ingredient (0.5% to 2.0%), as an wart active ingredient (12% to 40% in a plaster vehicle, 5.0% to 12% in a collodion-like vehicle, and 12% in a karaya gum, glycol plaster vehicle), as a dandruff, seborrheic dermatitis, or psoriasis active ingredient (1.8% to 3.0%), and as a preservative at a maximum concentration of 0.5%.
ProductVision enables the user to create statements tied directly to the resource, in this case Salicylic Acid. The same Guideline and Restriction statement can be used with multiple countries/regulatory bodies with different maximum levels and keywords. Once the Guideline and Restriction statements are complete and attached to the resource the user can run a Guideline Check. This will determine what specific restrictions exist for the ingredients at the specific amounts in the formula, on either a worldwide basis or for a specific country/region or customer. This capability allows your formulators to know about restrictions on a new or modified product at the very beginning of the development process and to make any necessary adjustments to meet market and/or customer requirements.
For more information about the Guidelines & Restrictions module and how your company can utilize its benefits, click here or contact your ProductVision Support representative.
The ProductVision® product development software is a product lifecycle management (PLM) system that manages all aspects of the product development process. Suitable for industries including paint & coatings, personal care and food & beverage, ProductVision’s comprehensive list of modules includes Formula Management, Regulatory, GHS, Project Management, Document Management, Ingredient Labelling, Guidelines & Restrictions, Sample Tracking, Testing and Workflow. We have your complete development process covered no matter what your industry.