In the ICPE nomenclature, the 4000 series headings are in effect

Since June 1^st 2015, the ICPE nomenclature has included 80 new categories numbered from 4000 to 4802, intended for classifying operating sites based on the quantities of hazardous products and waste that may be present. In the ICPE nomenclature, the 4000 series replaces 61 categories from the 1000 series, which have now been removed.

This major overhaul of the nomenclature requires every operator to conduct an exhaustive inventory of the hazardous materials used and stored on their site in order to determine their new ICPE classification and revalidate their potential Seveso status.

ICPE nomenclature, the 4000 series presented

Published as early as March 2014 [1] to inform operators as far in advance as possible of upcoming changes, the ICPE 4000 series aims to meet a dual objective:

• Harmonize the ICPE nomenclature with the new classification of hazardous substances and mixtures defined by the CLP regulation [2]
• Transpose the new classification thresholds for Seveso sites introduced by the Seveso 3 directive [3], which are themselves based on the CLP product classification.

It is therefore logical that the 4000 headings came into effect on^June 1st, 2015, the date from which the application of the CLP regulation also became mandatory for the classification and labeling of hazardous mixtures.

The structure of the 4000 headings within the ICPE nomenclature is as follows:

Headings definition and aggregation rule:

• 4000: Definition and classification of hazardous substances and mixtures,
• 4001 Seveso establishment by aggregation

Classification headings based on generic hazardous properties

• 41xx Toxic,
• 42xx Explosive,
• 43xx Flammable (gases, aerosols, liquids),
• 44xx Self-reactive substances, organic peroxides, pyrophoric solids and liquids, oxidizing solids, liquids and gases,
• 45xx Hazardous to the environment,
• 46xx Other Seveso hazards (reaction with water).

Classification headings for specifically named substances

• 47xx Specifically named substances,
• 4801 Coal, coke, lignite, charcoal, tar…,
• 4802 Fluorinated greenhouse gases or ozone-depleting substances

The 4000-series headings follow the standard ICPE classification principles, with each setting thresholds that trigger Declaration, Registration, and/or Authorization requirements based on the quantities of hazardous products. In a more innovative approach, the threshold quantities that subject a facility to Upper-Tier or Lower-Tier Seveso status are now listed under each relevant 4000-series heading. The "AS" designation, which previously indicated Upper-Tier Seveso status in the old 1000-series headings, has been removed. Previously listed separately in a ministerial decree, Lower-Tier Seveso thresholds are now included directly in the ICPE nomenclature, making them easier to track.

WHICH 1000-SERIES HEADINGS ARE STILL IN EFFECT?

As of June 1^st , 2015, only 19 headings from the 1000 series remain in effect. These headings cover:

• hazardous materials not covered by the CLP Regulation or the Seveso Directive (e.g., 15xx headings for combustible solids, 17xx headings for radioactive substances),
• specific activities involving hazardous products (e.g., Heading 1435 for service stations, Heading 1511 for cold storage warehouses)

Among the 19 remaining 1000-series headings, 2 are new and came into effect on June 1^st , 2015:

• Heading 1421: Flammable aerosol filling facilities
• Heading 1436: Storage or use of combustible liquids with a flash point* between 60°C and 93°C* Flash point = The temperature at which a product emits enough vapor to ignite.

What are the differences between the 4000-series headings and the repealed 1000-series headings?

1) The scope of the repealed 1000-series headings was based on the old classification of hazardous chemicals, whereas the 4000-series headings correspond to the hazard properties defined by the CLP Regulation.

There are several notable differences between the old and new chemical classification systems. For example:

• Several products previously classified as harmful by inhalation or ingestion may now be categorized as Category 3 acute toxicity under the CLP Regulation. These must now be accounted for under headings 4130 or 4140, whereas they were previously excluded from the old 11xx headings for toxic products.
• Flammable aerosols now constitute a distinct hazard class under the CLP regulation. Consequently, their storage or use is now classified under dedicated headings (4320 and 4321) based on the total quantity of the container. Previously, the quantities of flammable gases and liquids used in the composition of aerosols had to be accounted for separately under various 1000-series headings.
• A liquid must be considered a flammable liquid and accounted for under headings 4330 or 4331 only if its flash point remains below 60 °C. Under the former headings 1430, 1432, and 1433, the definition of flammable liquids included liquids with flash points up to 100 °C, or even higher in the case of heavy fuel oils. Furthermore, classification under headings 4330 or 4331 is now determined based on the actual quantity of flammable liquids, rather than the "equivalent total capacity" calculated using weighting coefficients based on the flammability characteristics of the liquids in question.

2) Classification under the 4000-series headings is based on the "quantity likely to be present in the facility," without distinguishing between manufacturing, use, or storage activities.

This quantity must be assessed by aggregating raw materials, work-in-progress (reactors, mixers, etc.), finished products, and waste (now expressly included), regardless of the form of use or storage.

N.B.: A facility classified under a 4000-series heading for the use/storage of hazardous products may also be classified as an activity under a 1000, 2000, or 3000-series heading of the ICPE nomenclature.

3) Certain hazard properties or product families previously covered under deleted 1000-series headings are not included in the 4000-series headings.

This is particularly the case for corrosive materials previously classified under 16xx headings or organohalogenated liquids falling under heading 1175. Consequently, the products concerned fall outside the scope of the ICPE nomenclature, unless they exhibit additional hazard properties covered by 4000-series headings. For example:

• hydrochloric acid, previously covered by heading 1611, must be classified under heading 4130 as a product toxic by inhalation (H331)
• perchloroethylene, previously covered by heading 1175, must be classified under heading 4511 as a product hazardous to the environment, chronic category 2

4) New specifically named substances are subject to specific 4000-series headings.

Headings 4709, 4713, 4722, 4734, and 4736 to 4749 group these new specifically named substances (e.g., specific petroleum products, sodium hypochlorite mixtures, methanol, etc.), which are now subject to specific classification thresholds requiring a separate assessment of the quantities stored/used.

Ultimately, with the exception of a few rare cases where 4000-series headings replace deleted 1000-series headings (e.g., heading 1185 replaced by heading 4802), all these changes make it essential for operators to conduct a new review of their ICPE classification, particularly to assert any potential grandfathering rights.

HOW TO BENEFIT FROM GRANDFATHERING RIGHTS FOLLOWING THE ENTRY INTO FORCE OF THE 4000-SERIES HEADINGS?

Under the rule of acquired rights [4], facilities subject to a change in ICPE status following a modification of the nomenclature may continue to operate the existing installations concerned without having to complete the corresponding administrative procedures (Declaration, Registration, or Authorization), provided they inform the prefect of the situation within one year.

This right of priority now also applies in the event of a change in ICPE status resulting from an evolution in the hazard classification of products used or stored on-site. In such cases, the one-year period begins on the date the product classification change comes into effect, rather than the date the decree amending the nomenclature is published. Since changes in ICPE status resulting from the application of sections 4000 are linked to the entry into force of the new CLP product classification on June 1^st , 2015, operators have until June 1^st , 2016, to notify the prefect of their new ICPE classification and assert their rights of priority.

Classification methodology

To establish a new ICPE classification under sections 4000, an operator must follow these 3 steps:

1. Create an inventory of hazardous substances and mixtures used/stored on-site, indicating the maximum quantities likely to be present and their hazard properties under the CLP regulation.

To identify and report the hazard properties of the listed hazardous substances and mixtures (hazard classes, categories, and H statements), it is necessary to refer to section 2 of the Safety Data Sheets (SDS):

One of the main challenges for operators is quickly obtaining updated SDS that incorporate CLP classification data for mixtures. In fact, for the latter, suppliers have only been required to produce SDS based on CLP since June 1^st , 2015.

Another option is to refer to the list of harmonized substance classifications found in Annex VI of the CLP regulation [5]. This list contains over 4,000 substances for which classification and labeling rules are mandatory for suppliers across Europe, including for mixtures containing them. However, the vast majority of substances available on the market are not included.

Identifying and classifying hazardous waste to be considered under sections 4000 can also be difficult in the absence of SDS and precise characterization data. However, such waste possesses properties similar to raw materials, intermediate products, or finished products, and their hazard categories and statements under the CLP regulation must be identifiable in order to determine the relevant 4000-series sections.

2. Identify the 4000-series sections corresponding to the hazardous substances and mixtures in question

The operator must first determine whether any of the hazardous products identified are substances or mixtures specifically named in sections 47xx or 48xx. For products not specifically named in a 47xx or 48xx section, the operator must then search for the 4100 to 4699 sections they may fall under, based on their generic hazard properties (toxic, flammable, oxidizing, etc.). To do this, an INERIS guide [6] provides very useful tables establishing the correspondence between the H hazard statements assigned to hazardous products and the 4000-series headings.

N.B.: A substance or mixture not specifically named in a 47xx or 48xx heading and presenting multiple hazard statements associated with several 4100 to 4699 headings must be classified primarily under the heading presenting, in order of priority:

• the lowest upper-tier Seveso threshold
• in the event of equal upper-tier Seveso thresholds, the lowest lower-tier Seveso threshold
• in the event of equal lower-tier Seveso thresholds, the lowest Authorization threshold
• in the event of equal Authorization thresholds, the lowest Registration threshold
• in the event of equal Registration thresholds, the lowest Declaration threshold.

3. The ICPE classification regime under each 4000-series heading

Once the classification heading has been defined for each hazardous substance and mixture, the applicable ICPE regime can be determined by comparing the quantities present on-site with the thresholds of the relevant 4000-series heading.

Based on the classification regime determined under each heading, the operator can finally identify the ministerial orders for requirements that apply to them. Nearly fifty orders are already applicable to facilities declared, registered, or authorized under 4000-series headings. These are orders that previously targeted facilities classified under deleted 1000-series headings, the scope of which was modified by an order dated May 11, 2015, to incorporate references to the corresponding new 4000-series headings.

Determining Seveso status

Beyond the ICPE regime of the facilities, the entry into force of this ICPE nomenclature, and more specifically the 4000-series headings, can also impact the Seveso status of certain establishments. In fact, the new breakdown of headings and the changes in product classification already described above also influence the conditions for assessing the Upper-tier (UT) and Lower-tier (LT) Seveso thresholds appearing at the end of each 4000-series heading.

Thus, according to an initial estimate by the Ministry of Ecology, 15% of establishments are expected to exit the Seveso regime, while 15% are expected to enter it [7]. However, the criteria for determining an establishment's Seveso status still follow the same principles:

• A site is classified as UT if: - For at least one of the 4000-series headings, the hazardous products in question are likely to be present in a quantity greater than or equal to the upper threshold quantity mentioned in the heading - OR the cumulative quantities of hazardous products meet the UT summation rule
• A site is classified as LT if it is not classified as UT AND if: - For at least one of the 4000-series headings, the hazardous products in question are likely to be present in a quantity greater than or equal to the lower threshold quantity mentioned in the heading - OR the cumulative quantities of hazardous products meet the LT summation rule.

HOW DO YOU DETERMINE SEVESO STATUS USING THE AGGREGATION RULE?

The aggregation rule defined in Article R. 511-11 of the Environmental Code allows a facility to be classified as Seveso Upper Tier (SH) or Lower Tier (SB) based on the cumulative quantities of products that pose health, physical, and/or environmental hazards, even if the Seveso thresholds set for each individual category are not met. In practice, however, this rule remains particularly complex to understand and apply. Therefore, to assist operators, the Ministry of Ecology provides a simulation tool to calculate a facility's Seveso status based on the quantities of hazardous products present on-site. Training materials including several examples of how to apply the aggregation rule are also available.

N.B.: Category 4001 of the ICPE nomenclature subjects any facility meeting the Seveso SH or SB aggregation rule to the Authorization regime. This means that Seveso-classified sites that would not otherwise have ICPEs subject to this regime must transition to the Authorization status.

Impacts for facilities becoming Seveso-classified

Facilities Seveso are subject to specific safety regulations designed to prevent the risk of major accidents they may cause due to the significant quantities of hazardous products handled. Slightly revised as of June 1^st 2015 in accordance with the Seveso 3 Directive, the procedures and requirements imposed on the relevant operators depend on the facility's status. They are summarized in this table:

Thus, a facility becoming Seveso-classified on June 1^st 2015 under the 4000 categories of the ICPE nomenclature must:

• complete an initial online inventory of the hazardous substances and mixtures present by December 31, 2015
• have developed its Major Accident Prevention Policy (PPAM) by June 1^st 2016
• if it becomes Seveso SH, implement its Safety Management System (SGS) and Internal Emergency Plan (POI) by June 1^st June 2017.

Conclusion

This latest overhaul of the ICPE nomenclature, with its numerous administrative and regulatory implications, further highlights the importance for companies to maintain an up-to-date inventory of their classified installations in line with current headings. As a natural extension of our monitoring and compliance assessment services, the ICPE tracking feature available in certain regulatory compliance software is specifically designed to simplify this process.

[1] Decree No. 2014-285 of March 3, 2014, published in the Official Journal on March 5, 2014

[2] Regulation (EC) No 1272/2008 of December 16, 2008 on classification, labelling and packaging of substances and mixtures

[3] Directive 2012/18/EU of July 4, 2012 on the control of major-accident hazards involving dangerous substances

[4] Article L. 513-1 & R. 513-1 to 2 of the Environmental Code

[5] http://echa.europa.eu/fr/information-on-chemicals/cl-inventory-database

[6] INERIS Guide "Application of the classification of dangerous substances and mixtures to the ICPE nomenclature", June 2014 (http://www.ineris.fr/centredoc/guide-technique---juin-2014-1404813170.pdf)

[7] According to figures from the Ministry of Ecology, as of December 31, 2013, France had 1,205 Seveso establishments, 657 of which were "Upper Tier"

‍