Disclaimer: The information in this article presents our understanding and views and is not legal advice. If you need more details on any legislation or legal advice about what action to take when labelling your products, please contact an adviser or solicitor.

The Delegated Act of the 15th ATP (adaptation to technical and scientific progress)- LILIAL (BMHCA) CLASSED AS TOXIC 19TH MAY 2020

What is Lilial and why is it being restricted?

Lilial. p-tert-Butyl-α-methylhydrocinnamic aldehyde (p-BMHCA)

CAS Number: 80-54-06

BMHCA is a fragrance ingredient with a floral note that has been used in perfumery for many years. Manufactured by BASF, over 10,000 tonnes are produced annually and BMHCA can be found in many popular fragrances. Following recent animal studies, BMHCA was found to be toxic for reproduction and was thus classified as unsafe for use in cosmetics within the EU. It was also determined that BMHCA should have limits applied in other home products, with a limit of 0.3% in the finished product. Further details are below.

The European Commission adopted the Delegated Act of the 15th ATP (Adaptation to Technical and Scientific Progress) on 19th May 2020. This lists BMHCA on Annex VI of the European Union’s Classification, Labelling and Packaging (CLP) Regulation as toxic for Reproduction category 1B. This has now been published in the Official Journal (OJ) on the 11th August 2020 and entry into force (EIF) took place on the 31st August 2020.

The use of BMHCA in new and existing cosmetic products is banned in the EU from 1st March 2022, 18 months after the EIF described above. This date refers to a ban ‘on-shelf’ of BMHCA-containing cosmetic products in the EU. This change in classification means that home care products marketed in the EU and sold to the general public such as detergents and air fresheners that contain 0.3 % or more BMHCA would be classified as CMR (carcinogenic, mutagenic, reprotoxic) 1b and therefore banned from sale.

What is Candle Shack doing about this?

Candle Shack have been working with our perfumers since summer 2021 to phase BMHCA out of our products and ensure our fragrance oils remain suitable for use after the 1st of March deadline. Several BMHCA replacers have been developed within the fragrance industry and they appear to be very good, resulting in little or no change in character to the original oils.

As well as ensuring the fragrance character remained consistent, our R&D team have also tested all perfumes with lilial replacers to ensure there is no difference in burn performance. We have conducted EN15493 (Fire Safety) and EN15426 (Sooting Behaviour) testing on all reformulations. Other than three fragrances (see below), we saw no notable difference in burn performance or wicking, so have been able to phase out BMHCA in most oils without any impact on our customers.

There were, however, three fragrances that had to be reformulated, as replacing the BMHCA alone resulted in a notable change to character and impacted the burn performance of the candle. These fragrances were:

• Marine
• English Rose
• Black Raspberry & Peppercorn

As the reformulations of these oils expanded beyond pure BMHCA replacement, all customers who had ordered these oils in the previous 12 months were emailed to notify them of the reformulation.

At the time of writing (14th February 2022), all but four fragrances containing 3% or more BMHCA have been updated and no longer contain this material. The four remaining fragrances and their maximum usage in candles, melts and diffusers from 1st March 2022 are:

• Blackberry & Bay (5% content)
• Cardamom & Mimosa (2.74% content)
• Oriental Bamboo (7.04% content)
• Peony & Blush Suede (7.5% content)

We are currently working on removing BMHCA from these fragrances but may reformulate them further to also safeguard their use in reed diffusers based on IFRA 49 restrictions (click here to read IFRA 49th amendment article). Until modifications are approved and released for these three oils, the levels of BMHCA (4% to almost 11%) mean they cannot be used at the usual 8% or 10% in candles from 1st March. We will notify everyone once these oils have been updated and are ready to launch.

What does this mean for candles, wax melts and diffusers?

As products that trigger CMR1b cannot be sold to the general public, and given that BMHCA triggers CMR1b when used above 0.3%, it follows that all finished home fragrance products must not contain more than 0.3% BMHCA from 1st March 2022. If you look on the IFRA Allergen Certificate (your fragrance supplier should provide this) for your raw perfume and can see BMHCA on the list (it has other names, so check for CAS 80-54-06), then check the percentage. If you cross-reference using the table below, you will see the maximum percentage of fragrance that can be used in a product without triggering CMR1b.

Example
If your perfume contains 4.0% BMHCA, it can be used at up to 7.5% in your candle/melt/diffuser. If you used 15% of this oil, you would exceed 0.3% BMHCA in the finished product and should not legally sell this product.


Note: The table below is purely for Lilial, which may not be the only hazardous ingredient in your fragrance oil, so you should also take any other CLP restrictions into account. Your supplier should let you know maximum concentrations, especially for reed diffusers, using specialist regulatory software.

% BMHCA

Fragrance Content

1.5%

20%

2.0%

15%

2.5%

12%

3.0%

10%

3.5%

8.56%

4.0%

7.5%

4.5%

6.66%

5.0%

6%

5.5%

5.45%

6.0%

5%

6.5%

4.61%

7.0%

4.28%

7.5%

4%

8.0%

3.75%

8.5%

3.53%

9.0%

3.33%

9.5%

3.16%

10.0%

3%

What should I do with oils I bought previously?

The transitioning out of BMHCA (where content >3%) took place in the second half of 2021. This means that any fragrance you have purchased from Candle Shack in 2022 will be BMHCA free unless stated otherwise in the IFRA Allergen Certificate. If you are not sure when you purchased a particular bottle of fragrance, you will see a 6-digit numerical Batch Number on the bottle. We have added information to the fragrance pages of all affected fragrance oils, listing the final batch of oil that contained BMHCA.

If the batch number on your bottle is greater than the 'last batch' number, your oil is BMHCA free and can be used as normal. If the batch number on your bottle is the same or is lower than the 'last batch' number on the product page, then your bottle contains BMHCA.

Any products made using BMHCA containing batches of oil must not exceed the maximum content specified. The notification looks like this example taken from the Lime Basil Mandarin page:

Lilial Removal. Please note, the lilial in this fragrance was removed in Summer 2021 and it no longer contains Lilial. The last batch number containing Lilial was 175356. If you have older oil that has this batch number (or a lower number), the maximum fragrance level in candles and diffusers is now 7.5% and the oil should not be used in cosmetics. This change is effective 1 March 2022.

As you can see, the last batch containing BMHCA was 175356. So, if you had an older bottle with batch number 174554 (lower than 175356), then you should restrict the fragrance content to a maximum of 7.5% for any products made using this bottle.

Can I still use boxes or CLP labels I had printed before the change?

It is not unusual for makers to bulk purchase packaging and many customers do so. This leaves them vulnerable to changes such as this, as the CLP warnings on their products may change if fragrances need to be modified. As we are replacing a hazardous material with a non-hazardous one, your CLP labels are NOT under-stating the hazards and endangering customers. Quite the opposite. In most cases the label will remain almost completely unchanged for the modified oils, other than the removal of lilial from the 'Supplemental Information' line.

Remember, CLP regulation was introduced to protect downstream users (i.e. customers), by ensuring they are aware of the hazards associated with products before buying or using them. If you are using BMHCA free versions of the oil, you are supplying an even safer product and are there is nothing in your product that has not been disclosed. I.e. nothing hazardous has been added that is not already declared.

Everything tends to get 'rounded up' in CLP and most products slightly overstate the hazards. For example, many perfumers will provide a 'banded' SDS on raw perfume oils to protect their Intellectual Property (IP). This often results in ingredients being stated as a range, i.e. 'between 20% and 50%'.

When we add these fragrances to our CLP software, if we have banded ranges on the fragrance SDS, we need to assume the worst and use the top of the range (i.e. 50% in the above example). When we then generate SDS' for candles or diffusers, it often leads to overstating hazards, but never results in customers receiving a more hazardous product than what is on the label.

If like others, you have bought boxes over the last 12-18 months for the original oils, I would advise you not to rush out and buy new ones. The hazards may be slightly overstated in the short term, but as outlined above this is pretty normal with CLP. The CLP can then be updated to remove lilial references next time your boxes or labels are printed.

Do IFRA 49th amendment and lilial restrictions affect UK and EU customers differently?

IFRA 49 and the Lilial ban affect both our UK and EU customers. It is worth noting, however, lilial ban is legally binding whereas IFRA 49th amendment isn’t.

Nevertheless, since all major European perfume manufacturers are IFRA members, they are obliged to apply IFRA standards. As such, treating IFRA guidelines as if they are legally binding to ensure the safe use of fragrance for consumers.

Candle Shack adheres to IFRA standards and, therefore, will not be offering CLP for diffusers above IFRA limits from 10th May 2022 to comply with IFRA 49.

Further Questions

If you have any further questions on Lilial (BMHCA), please don't hesitate to get in touch and we will do what we can to help.