What does it require to get The Blue Label?
For a product to be Blue Label-approved, we require that it constitutes a minimal allergy risk for consumers.
Requirements for ingredients
All substances can give contact allergy. But some substances cause contact allergy more frequently than others. Substances to which many people are allergic are not allowed in products with The Blue Label.
These substances include, but are not exclusively:
- Perfume – both natural and synthetic
- Added formaldehyde or formaldehyde donors
- Kathon, MI and MCI
Certain extracts such as Aloe Vera are required to be purified from allergenic substances.
In addition dyes and pigments are not allowed to be in contact with the skin unless they serve a specific purpose eg. in make up. If used they need to fulfill the same criteria as other substances.
Substances that can cause irritation
If the skin is irritated, there is a greater risk of developing contact allergy. Skin can become irritated in many ways, but some chemical substances can also irritate the skin. This is why we require for these substances to only be found in small amounts. How much is allowed depends on the other ingredients and the use of the product, e.g. whether the product is washed off (rinse-off) or stays on the skin (leave-on). Products are therefore always assessed individually.
In Kemilex, you can see see all ingredients that we have assessed and our conclusion regarding allergy risk: those which are not allowed, those whose use is limited and those which can be used without problem.
For certain types of products, we have detailed criteria. These products can be seen below. We will continue to add to this list, with the goal of producing criteria documents for all product types:
- Criteria for cosmetic products (incl. wet wipes and make up)
- Background documents for cosmetisc products
We must have full insight into the ingredients
In order to assess whether a product can be carry our allergy label, we require information on how the product will be used and on all its ingredients, including concentrations. We must also be sent the substances’ CAS numbers, as well as their safety data sheets and technical data sheets.
For personal care products and detergents, we require that all ingredients are declared on the label.
For a number of products, such as nappies, wet wipes, paper products and paints, you as a manufacturer may not be aware of all the ingredients. So that we can make a full assessment, we must have the data from your supplier. We sometimes need to have data from many sub-suppliers in order to get all the information we require for our assessment. We can draw up Confidential agreements with any sub-suppliers who do not want to pass on information about their ingredients through you.
How we assess
When we assess whether a substance may cause allergy or is an irritant, we use knowledge from a variety of databases and journals.
They include, amongst others, harmonised classifications, classification proposals, CIR (cosmetic ingredients review) reports, BotaDerma, Botanical Dermatology Database, Toxnet, Medscape, Videncenter for Allergi (the Information Centre for Allergy), Dermatitis and Contact Dermatitis.
We must have an agreement
Before we can assess whether one or more of your products can be a part of our ingredients declaration scheme, we must sign a partnership agreement. It outlines, amongst other things, the partnership’s obligations when it comes to product changes, spot checks, and marketing of the products.
Case processing time
When you send us your application, it generally takes us 1-1.5 months from the time the application was sent to make our decision. This is however dependent on all the required data having been sent to us.
For certain products, such as nappies, duvets, and paper products, our experience tells us that it can take some time to get all the required data from suppliers, sub-suppliers and sometimes even sub-sub-suppliers. Once we receive your application, we register it in our queue with your application date and then the process of collecting the data starts straight away. If the collection of data takes long, we will start processing your application as soon as we have gathered all the required data.
All changes must be assessed
When a product is part of our ingredients declaration scheme, the validity of our approval is based on the information we were sent on the following:
- Product name
If there are changes in any of the above, you must apply for our approval to be amended accordingly.
Our pricing model is made up of two different payments:
- Assessment of the product prior to the approval
- Turn-over fee on The Blue Label products
We charge an hourly fee for our assessment of 1,020 kr. per hour.
Invoices are sent four times a year. If the assessment of a product runs across several invoicing periods, you may receive more than one invoice for your product. Please note, however, that you will still only be charged for the hours that we have spent on your assessment.
You will receive a invoice for turn-over fee twice a year.
The amount on this invoice will vary depending on the turnover of your labelled products. Before we send it to you, you will be sent a letter where we ask you for information on your turnover.
The annual fee depends on your turnover, and is broken down as follows:
- 0.7 percent of your turnover up to 10 million kr.
- 0.5 percent of your turnover between 10 and 20 million kr.
- 0.2 percent of your turnover over 20 million kr.
We have a minimum yearly fee of 15,000 kr. and a maximum one of 350,000 kr. These minimum and maximum yearly fees are applied to the total turnover of all your Blue Label products.
There is no annual fee for products sold abroad which also carry another local asthma-allergy association label.
In 2016, 2017 and 2018 we have a special focus on the foreign market. Therefore the turn-over fee for products sold out side Denmark and the Nordic countries will only be 0.2 percent.
The annual fee covers operating costs in connection with our brand, such as administration, maintenance and updating of Kemilex, approval of artwork, as well as general product discussions, consumer inquiries, etc.