What are BVL standards and how can my product comply?

What is the BVL?
The Federal Office of Consumer Protection and Food Safety (BVL) is a German agency that establishes cosmetic monitors for heavy metals and similar guidelines.

What is the relationship between the BVL standards and EU legislation?

Regulation (EC) No 1223/2009 on cosmetic products states that no substance listed in Annex II may be present in cosmetic products. These include heavy metals lead, arsenic, cadmium, antimony, and mercury and their compounds. The only is exception the unique situation listed in Annex V as preservatives.

The unintentional presence of these heavy metals in cosmetic items is only permitted under good manufacturing practice (GMP) if it is technically impossible to avoid and the products are nonetheless safe for human health, as per Article 17 of the same Regulation. The safety of each individual product must be proven in the PIF or CPSR (essentially, this is what you hired SkinConsult to do!).

However, these prohibitions do not contain concrete values so that the producer and responsible person of the cosmetics product know what values they must attain to. The BVL released technically avoidable level values 2005. These values are what SkinConsult refers to when considering whether a cosmetic product is safe during the preliminary report.

What are the specific BVL standards?
The BVL standards are as follows:

*Exception: For the products make-up powder, rouge, eye shadow, eyeliner, kajal, as well as theater, fan or carnival make-up: 5 mg/kg
**For theater, fan or carnival make-up: 2.5 mg/kg

The limit is higher for makeup as often contain pigments that tend to contain higher concentrations of heavy metals.

The BVL can justify these standards by carrying out heavy metal analyzes for cosmetic products annually. A threshold is determined from these analyses. For exmaple, 80% of the products in a specific category (e.g women's facial serum) can meet a specific concentration, so this becomes this threshold concentration. This leads to a normal distribution with a cut-off.


How can my product comply to the standards?
SkinConsult always checks whether your product complies with BVL standards. Enclosed is a step-by-step outline of how we do this:
1. For each raw material the producer must upload a document stating the heavy metals in the raw material. If the raw material, this must be declared as well.

2. SkinConsult calculates the sum of all the heavy metals in all the raw materials.

3. During our preliminary report check, we ensure that your product contains less heavy metals than is allowed according to the BVL standard.

What can I do when my product does not comply to BVL standards?
If your product does not comply with the BVL standards,this doesn't necessarily have to be a safety issue! If it falls under the 'technically unavoidable' category mentioned above, your product can be approved by the German authority, but you must be able to prove this. Please read the step-by-step roadmap.

1. Determine exact concentration through more accurate measurement (please check out our testing partners)
2. If the test shows the product is above the limit, determine whether this is 'technically unavoidable'
   1. Find out which raw material causes this by using our BVL tool.
   2. See if there are alternatives for these raw material(s) through your producer
      1. If so, please replace and perform a new analysis to check if it falls below the limit. If there are alternatives, this does not fall under technically unavoidable
      2. If not then it is OK, because it would fall under the "technically unavoidable" category
   3. Documenting the investigation and/or drafting a statement
      
      

If in the end you do not manage to get your products under the heavy metal BVL limits, we suggest you do not sell your products in Germany.

We hope to have informed of BVL standards, what they are and how you can comply with German authority standards. If you have other questions about legislation, please contact: office@skinconsult.com.


Remember, safety first!