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EU Safety Gate report 2023 Summary

Last Updated: Tuesday, September 17, 2024 12:55 PM - Data up to Week 37 - 2024

The Annual Summary Report provides a comprehensive overview of safety alerts issued by the European Union for non-food products throughout the year. This report highlights the most notable data and trends, including significant increases or decreases in alerts.

Data Includes:

Common types of hazards (Risk Type)
Categories of products most frequently flagged
Country of product origin
Countries submitting alerts
Regulatory action required
Regulatory identification of responsible party
Brand Owners

And more.

It aims to give readers a clear and concise understanding of the key safety concerns and regulatory actions taken within the year.

Annual Alerts

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Total Annual Alerts Issued

Over the last few years, the EU Safety Gate member states issue on average around 2,000 - 2,200 safety alerts per year.

Around 25% of all alerts issued are for products where the Country of Origin is unknown.
On average China represents around 50% of Alerts issued
2023 was exceptional with 3412 alerts issued (according to the EU) or 3,349 (according to my analysis).

Metric	2005	2006	2007	2008	2009	2010	2011	2012	2013	2014	2015
Count	559	831	1,274	1,465	1,577	1,854	1,520	1,873	2,008	2,236	1,851
% Change	0	49	53	15	8	18	-18	23	7	11	-17
Change	0	272	443	191	112	277	-334	353	135	228	-385

Metric	2016	2017	2018	2019	2020	2021	2022	2023
Count	1,868	2,013	2,030	2,113	2,156	2,055	2,072	3,245
% Change	0	8	1	4	2	-5	1	57
Change	0	145	17	83	43	-101	17	1,173

Annual Alerts Issued - YoY Change

2023 saw a 59% increase in the average number of alerts issued in a year, with the total alerts issued increasing from 2,100 alerts in 2022 to 3,349 in 2023, an increase of 1,249 over the previous year.

All Countries Annual & Cumulative Alerts	All Countries Annual YoY Change and Cumulative Alerts

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Submitting Country

The Submitting Country category provides detailed information on which EU country has reported a safety alert to the EU Safety Gate team. This category highlights the active role each member state plays in monitoring and ensuring the safety of non-food products within the European market. By identifying the submitting country, the report can track trends and patterns in regulatory vigilance and responsiveness across different regions. This information is crucial for understanding the distribution of safety concerns and the collaborative efforts of EU countries in safeguarding consumer health and safety through prompt and effective reporting of hazardous products.

Alert submitted by	2022	2023	change
Germany	421	433	2.9%
Italy	47	788	1576.6%
Sweden	134	376	180.6%
France	196	291	48.5%
Hungary	135	301	123.0%
Poland	166	136	-18.1%
Lithuania	121	102	-15.7%
Romania	87	128	47.1%
Ireland	84	97	15.5%
Czechia	80	100	25.0%

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Previous Year Vs Current Year

Italy exhibited a remarkable surge in enforcement activity, with the number of alert submissions from Italy skyrocketing from 47 in 2022 to 788 in 2023. This substantial increase is primarily attributed to the ban on the chemical Lilial in cosmetics. Italy's proactive stance in enforcing this regulation has led to a significant rise in reported cases, highlighting the country's commitment to consumer safety and stringent regulatory practices. This spike underscores the critical role of national authorities in identifying and mitigating risks associated with hazardous substances, ensuring the safety and well-being of consumers across the European Union.

Map Plot Previous Year Vs Current Year

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Product Categories

product_category	2022	2023	change
Cosmetics	207	1,072	417.9%
Toys	477	433	-9.2%
Automotive	336	396	17.9%
Electrical Appliances	165	330	100.0%
Clothing \ Fashion	195	248	27.2%
Other	156	173	10.9%
Jewellery	133	153	15.0%
Childcare Equipment	62	106	71.0%
Chemicals	55	99	80.0%
Lighting	79	61	-22.8%
Protective Equipment	79	54	-31.6%
Machinery	44	62	40.9%
E-Cig	56	23	-58.9%
Hobby \ Sports	28	35	25.0%

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Over the last few years the Toys and Automotive categories are generally those with the most safety alerts.

The exception being 2023 where cosmetics took the top spot with 32% of all alerts issued being for cosmetic products.

The Toys category saw a slight decrease in alerts by 6.6%. Despite the drop, it still represents a substantial portion of the total alerts at 17.1%, indicating ongoing concerns in this category.

Automotive alerts increased by 17.1%, reflecting continued vigilance and possibly increased regulatory scrutiny or new safety standards affecting automotive products.

Electrical Appliances saw a significant increase of 98.2%, nearly doubling from the previous year. The rise may be due to enhanced safety checks and reporting mechanisms for electrical appliances.

What happened between 2022-2023?

Cosmetics

2023 was an exception with the introduction of the ban on the chemical lilial / BMHCA for use in cosmetics on 1st March 2022.

In 2023 1,072 safety alerts were issued for products containing the chemical BMHCA
Around 30% of these were issued to products manufactured in Italy

The significant increase seen 2023 over 2022 is due to a change in regulations for a Butylphenyl Methylpropional (BMHCA, trade name 'Lilial') BMHCA, a chemical commonly used in cosmetics.

BMHCA is now deemed to be hazardous and unsuitable for use in cosmetic products due to the fact that it is included in so many products. While an individual exposure poses a minimal risk, cumulative exposure from the use of multiple products containing this chemical increases the risk considerably.

It's also worth noting that BMHCA is a fragrance commonly used in household cleaning products, however no guidance has been issued for it's use in cleaning products at this stage.

BMHCA "Lilial" Molecule

Since 1 March 2022, butylphenyl methylpropional (BMHCA/'Lilial') is classified as a Carcinogenic, Mutagenic or Reprotoxic (CMR) category 1B substance under the EU and GB Classification, Labelling and Packaging (CLP) Regulations.

This ban affected around 1,100 - 1,200 products (90-95% of the annual increase of (1,249) alerts or 32-35% of all alerts issued (3,349) in 2023), and is the reason for the significant increase seen in the Safety Gate analysis.

UK and BMHCA

Article 15 of the UK and EU Cosmetics Regulations requires CMR-classified substances to undergo an exemption process to assess whether they can continue to be used as cosmetic ingredients. This regulatory process has not yet been completed under the UK Cosmetics Regulation. Therefore, the new EU provisions for BMHCA/'Lilial' do not apply in GB. However, a ban is expected in GB on 15 December 2022 (the 'off- shelf' date).

While companies have been working towards the deadline of 1 March 2022 for products for both the EU and UK markets, as advised by CTPA, as of revision date of this statement, BMHCA/'Lilial' can be legally used in cosmetic products in GB until:

15 October 2022, as placing on the market deadline;
15 December 2022, as making available (off-shelf) deadline.

The Cosmetic, Toiletry and Perfumery Association (CTPA) advised its members to voluntarily remove Lilial from cosmetic products by the end of 2021. The UK's cosmetic regulation has since been updated to include Lilial in Annex II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS

What about other markets?

Lilial is still permitted for use in cosmetics in other countries outside the EU and the UK.

Scientific Opinion on BMHCA

Does the SCCS consider Butylphenyl methylpropional (p-BMHCA) safe for use as a fragrance ingredient in cosmetic leave-on and rinse-off type products in a concentration limit(s) according the ones set up by IFRA as reported above?

On individual product basis, Butylphenyl methylpropional (p-BMHCA) (CAS 80-54-6) with alpha-tocopherol at 200 ppm, can be considered safe when used as fragrance ingredient in different cosmetic leave-on and rinse-off type products. However, considering the first-tier deterministic aggregate exposure, arising from the use of different product types together, Butylphenyl methylpropional at the proposed concentrations cannot be considered as safe.

"first-tier deterministic aggregate exposure" refers to an initial, simplified assessment of total exposure to a particular substance from all sources and routes, using fixed input values for variables. This approach provides a preliminary estimate of exposure that can help identify potential risks and determine whether more detailed, possibly probabilistic, and higher-tier assessments are needed. It's a conservative approach that aims to ensure safety by not underestimating potential exposure levels, but it might not capture the full variability and uncertainty inherent in real-world exposure scenarios.

This Opinion is not applicable to the use of p-BMHCA in any sprayable products that could lead to exposure of the consumer's lung by inhalation.

Does the SCCS have any further scientific concerns with regard to the use of Butylphenyl methylpropional (p-BMHCA) as a fragrance ingredient in cosmetic leave-on and/or rinse-off type products?

Evaluation of this substance by other scientific bodies (e.g. under REACH) should also be taken into consideration by the Applicant for potential future assessment of the substance. Butylphenyl methylpropional is also used as a fragrance ingredient in some non-cosmetic products such as household cleaners and detergents. As no specific exposure data were made available to SCCS to assess exposure following these non-cosmetic uses, it was not possible to include them in the aggregated exposure scenarios. Therefore, the actual total exposure of the consumer may be higher than exposure from cosmetic products alone.

https://health.ec.europa.eu/system/files/2021-08/sccs_o_213_0.pdf

The European Cosmetics Industry

Cosmetics Country of Product Origin

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Cosmetics Sub Categories affected by the ban

product_sub_cat	2022	2023	change
Perfume/ Aftershave	49	502	924.5%
Soap Products	14	202	1342.9%
Moisturiser	43	77	79.1%
Hair-Care Products	23	87	278.3%
Deodorant Products	2	89	4350.0%
Skin-Lightening Products	36	28	-22.2%
Make-up Products	9	18	100.0%
Other	3	17	466.7%
Sun-Protection Products	5	14	180.0%
Skin-Care Products	5	13	160.0%

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It is estimated that the cosmetics and personal care industry brings at least €29 billion in added value to the European economy annually. €11 billion is contributed directly by the manufacture of cosmetic products and €18 billion indirectly through the supply chain (Eurostat 2015).

Including direct, indirect and induced economic activity, the industry supports over 3.6 million jobs. In 2022, over 254,259 people were employed directly, and a further 2.78 million indirectly in the cosmetics value chain.

For every 10 workers employed in the European cosmetics and personal care industry, at least two further jobs are generated in the wider economy as a result of employees spending their wages on goods and services.

Source: https://cosmeticseurope.eu/our-industry/

Cosmetic Products Safety Gate Alerts, Country of origin

Country of origin	2022	2023	change
Italy	21	393	1771.4%
Unknown	60	113	88.3%
France	18	96	433.3%
Poland	2	85	4150.0%
Germany	6	63	950.0%
Spain	8	59	637.5%
China	5	41	720.0%
UAE	12	32	166.7%
UK	15	23	53.3%
Netherlands	3	28	833.3%

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Italy and Cosmetics

Italy represents a significant portion of the European cosmetics and personal care products market, with a value of €11.5 billion.

This places Italy among the largest national markets within Europe, following Germany (€14.3 billion) and France (€12.9 billion).

Cosmetic Products Safety Gate Alerts, Top 30 Brands

Brand	2022	2023	change
Unknown	40	52	30.0%
Gordano Parfums	1	40	3900.0%
Nivea	0	39	-
Real Time	0	35	-
Comin Parfum	0	35	-
Palmolive	0	28	-
Glamour Profumi	3	24	700.0%
Tesori Doriente	0	26	-
Prady Parfums	0	23	-
Cuba	0	23	-
Omerta	1	21	2000.0%
Malizia	0	17	-
Borotalco	0	16	-
Intesa	0	16	-
Vidal	0	16	-
Loreal Paris	0	15	-
Dorall Collection	0	14	-
Perlier	0	12	-
Dream Cosmetics	5	6	20.0%
Mavi Profumi	0	11	-
Creation Lamis	0	11	-
Jfenzi	0	11	-
Biopoint	0	10	-
Breeze	0	10	-
Perfume De Qualitè	0	10	-
Vittorio Bellucci	0	10	-
Splendor	2	7	250.0%
Neutro Med	0	9	-
New Brand	0	9	-
Dove	0	9	-

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Which countries' products get the most alerts?

The following visualisations show the Economic Area of Product Origin with categories defined as:

EU Countries within Schengen or European Economic Area (Ex Italy for visibility of 2023 alerts)
Italy - Italy represents around 15% of all alerts issued in 2023 and is highlighted for the 2023 exception
Outside EU - Every other country not within the Eu Countries
China - China represents a large proportion of Global Trade

economic_area	2022	2023	change
China	1,033	1,166	12.9%
EU Countries	456	1,270	178.5%
Outside EU	583	809	38.8%

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Country of Product Origin

Within the Top 15 countries are two entries :

other

Unknown

country_top15	2022	2023	change
Unknown	602	841	39.7%
China	717	724	1.0%
Italy	55	523	850.9%
other	162	262	61.7%
Germany	146	241	65.1%
France	84	161	91.7%
Poland	27	116	329.6%
Turkey	73	65	-11.0%
Spain	25	87	248.0%
UK	45	63	40.0%

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Risk Category

In the context of non-food product safety alerts on the European Safety Gate website, product categories are meticulously mapped to various risk types to enhance consumer protection and regulatory oversight.

This mapping is further consolidated in this report from the 81 Product Categories in Safety Gate to a simplified group of categories more suited to analysis.

Further mapping has taken place on the Risk Category field to reduce this from 221 categories to 13 risk_categories used in this reporting.

This mapping enables a detailed understanding of the specific hazards associated with different types of products.

The identified risk_categories include Breathing Obstruction, Burns, Chemical, Drowning, Electric Shock, Entrapment, Environment, Eyesight Damage, Fire, Health Other, Hearing Damage, Injuries, and Microbiological. Each risk type represents a potential danger that a product could pose to consumers. For example, toys might be linked to risks such as Breathing Obstruction and Choking, while electrical appliances might be associated with risks like Electric Shock and Fire. By categorizing products according to these risk types, the European Safety Gate provides a structured framework for reporting and responding to safety issues.

The majority of Injury risks come from the automotive product category (9.7% of 2022/2023 total)
The majority of risks from Toys are breathing obstruction (7% of total) and chemical (7% of total)
As previously noted the cosmetics risk is from the recent ban of the chemical BMHCA

risk_category	2022	2023	change
Chemical	729	1,682	130.7%
Injuries	515	648	25.8%
Breathing Obstruction	334	264	-21.0%
Electric Shock	127	177	39.4%
Environment	84	192	128.6%
Burns	120	98	-18.3%
Fire	77	111	44.2%
Microbiological	28	25	-10.7%
Eyesight Damage	21	20	-4.8%
Drowning	17	5	-70.6%

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Product Category mapped to Risk Category

product_category	Breathing Obstruction	Burns	Chemical	Drowning	Electric Shock	Entrapment	Environment	Eyesight Damage	Fire	Health Other	Hearing Damage	Injuries	Microbiological
Automotive	0	7	0	0	3	0	39	0	156	0	1	526	0
Chemicals	0	1	152	0	0	0	0	0	0	0	0	0	1
Childcare Equipment	71	1	8	1	0	8	0	0	0	2	1	75	1
Clothing Fashion	108	0	130	0	0	1	6	0	0	0	0	198	0
Cosmetics	2	0	1245	0	0	0	3	0	0	0	0	3	26
E-Cig	0	0	76	0	0	0	0	0	0	0	0	2	1
Electrical Appliances	0	55	58	0	199	0	137	3	9	0	0	21	13
Hobby Sports	2	2	37	4	0	0	4	0	0	0	0	14	0
Jewellery	0	0	278	0	0	0	8	0	0	0	0	0	0
Lighting	0	37	2	0	87	0	10	0	1	0	0	3	0
Machinery	0	5	0	0	12	0	0	10	1	0	0	78	0
Other	29	88	50	15	3	6	23	15	21	0	4	73	2
Protective Equipment	5	0	9	2	0	0	0	1	0	0	0	114	2
Toys	381	22	366	0	0	5	46	12	0	0	15	56	7

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Action Required

The increase in the percentage of alerts requiring a ban from sale in 2023 is due to the ban of the chemical BMHCA in cosmetics.

The term "action required" delineates the measures that need to be taken to address identified safety concerns. These actions can be either voluntary or compulsory. Voluntary actions are initiated by the responsible party, such as the manufacturer, importer, or distributor, who, upon recognizing a potential safety issue, proactively undertakes corrective measures. These may include product recalls, issuing safety warnings, or making design changes to enhance product safety. Voluntary actions reflect the responsible party's commitment to consumer safety and regulatory compliance.

Conversely, compulsory actions are mandated by regulatory authorities following inspections, market surveillance, or consumer complaints.

action	2022	2023	change
Withdrawal	909	1,232	35.5%
Recall	815	1,004	23.2%
Ban	169	1,078	537.9%
Removal	206	216	4.9%
Warnings	195	162	-16.9%
Borderstop	135	179	32.6%
Destruction	117	153	30.8%
Criminal	0	2	-

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Responsible Party

The term "responsible party" refers to the entity accountable for the product safety issue. The identification of the responsible party can occur through two distinct pathways: voluntary or compulsory. A voluntary identification occurs when the responsible party, such as a manufacturer, importer, or distributor, proactively raises a safety alert regarding their product. This demonstrates a commitment to consumer safety and regulatory compliance, allowing for swift action to mitigate potential risks. On the other hand, compulsory identification happens through regulatory action, where authorities, during routine inspections or investigations, identify the responsible party and mandate corrective measures.

responsible	2022	2023	change
Unknown	1,967	3,125	58.9%
Disti	436	1,291	196.1%
Importer	608	625	2.8%
Manufacturer	450	601	33.6%
Retail	344	653	89.8%

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Top 30 Worldwide brands for Safety Alerts

Brand	2022	2023	change
Unknown	474	661	39.5%
Mercedes-Benz	52	40	-23.1%
Lexus	20	22	10.0%
Bmw	16	25	56.2%
Gordano Parfums	1	40	3900.0%
Nivea	0	39	-
Citroen	15	21	40.0%
Real Time	0	35	-
Comin Parfum	0	35	-
Opel	17	17	0.0%
Peugeot	21	13	-38.1%
Palmolive	0	28	-
Ford	10	18	80.0%
Glamour Profumi	3	24	700.0%
Tesori Doriente	0	26	-
Jaguar Land Rover	9	16	77.8%
Prady Parfums	0	24	-
Cuba	0	23	-
Omerta	1	21	2000.0%
Vw	8	13	62.5%
Ds	10	8	-20.0%
Fyrværkerieksperten	3	15	400.0%
Malizia	0	17	-
Vidal	0	16	-
Intesa	0	16	-
Kia	7	9	28.6%
Borotalco	0	16	-
Hyundai	8	7	-12.5%
Fiat	7	8	14.3%
Loreal Paris	0	15	-

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Top 15 Countries - Key Fact sheets

Programmatically created reproductions of the Top 3 Risk and Product categories by country visualisation in the official Fact sheet. Safety_Gate_2023_Factsheet_EN.pdf