In the ICPE nomenclature, the 4000 headings are in force

Since June¹, 2015, the ICPE nomenclature has included 80 new headings numbered 4000 to 4802 designed to classify operating sites according to the quantities of hazardous products and waste likely to be present. In the ICPE nomenclature , the 4000 headings replace 61 headings in the 1000 series, which have now been abolished.

This major overhaul of the nomenclature requires each operator to carry out an exhaustive inventory of the hazardous materials used and stored on its site, in order to determine its new ICPE classification and revalidate any Seveso status.

ICPE nomenclature, 4000 headings presented

Published as early as March 2014 [1] in order to inform operators as far in advance as possible of forthcoming changes, in the ICPE nomenclature the 4000 headings aim 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 Seveso site classification thresholds introduced by the Seveso 3 Directive [3], themselves based on the CLP classification of products.

It is therefore only logical that the 4000 headings should come into force on June¹, 2015, the date from which application of the CLP regulation also becomes mandatory for the classification and labeling of hazardous mixtures.

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

Definition and accumulation rules :

• 4000: Definition and classification of hazardous substances and mixtures,
• 4001 Cumulative Seveso plant

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 Dangerous for the environment,
• 46xx Other Seveso hazards (Reaction with water).

Classification headings for named substances

• 47xx Named substances,
• 4801 Coal, coke, lignite, charcoal, tar...,
• 4802 Fluorinated greenhouse gases or ozone-depleting substances

The 4000 headings do not depart from the classification principles of the ICPE nomenclature, and each sets thresholds for Declaration, Registration and/or Authorization, depending on the quantities of hazardous products. More innovatively, the threshold quantities subjecting an establishment to Seveso Haut or Seveso Bas status are now listed below each 4000 heading concerned. The reference to "AS", which corresponded to Seveso Haut status in the former 1000 headings, has disappeared. Previously listed separately in a ministerial decree, Seveso Bas thresholds now also appear in the ICPE nomenclature, making them easier to take into account.

WHICH 1000 HEADINGS ARE STILL IN FORCE?

As of June^1, 2015, only 19 headings in the 1000 series remain in force. These are headings for :

• 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., item 1435 on service stations, item 1511 on cold stores)

Among the 19 1000 headings, 2 are new and come into force on June^1, 2015:

• Category 1421: Filling installations for flammable aerosols
• Heading 1436: Storage or use of combustible liquids with a flash point * between 60°C and 93°C* Flash point = Temperature at which a product emits sufficient vapors to ignite.

What are the differences between 4000 and 1000 deleted headings?

1) The scope of the deleted 1000 headings was based on the old classification of hazardous chemicals, while the scope of the 4000 headings corresponds to the hazard properties determined by the CLP regulation.

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

• A number of products previously classified as harmful by inhalation or ingestion may present category 3 acute toxicity under the CLP regulation. In such cases, they must be included under headings 4130 or 4140, whereas they were excluded from the former 11xx headings for toxic products.
• Flammable aerosols are now a hazard class in their own right under the CLP regulation. Consequently, their storage or use is now classified under dedicated headings (4320 and 4321) according to the total quantity of the container. Previously, the quantities of flammable gases and liquids contained in aerosols had to be accounted for separately under different 1000 headings.
• A liquid can only be considered a flammable liquid and recorded under headings 4330 or 4331 if its flash point remains below 60°C. Under the former headings 1430, 1432 and 1433, the notion of flammable liquids included liquids with a flashpoint of up to 100°C, or even higher in the case of heavy fuel oils. In addition, classification under headings 4330 or 4331 is determined on the basis of the actual quantity of flammable liquids, and no longer on the basis of the "total equivalent capacity" calculated using weighting coefficients according to the flammability characteristics of the liquids in question.

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

This quantity is to be assessed by aggregating raw materials, work-in-process (reactors, mixers, etc.), finished products and waste (now expressly included), whatever the form of use and storage.

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

3) Certain hazard properties or product families previously covered by deleted 1000 headings are not included in 4000 headings.

This is notably the case for corrosive materials previously classified under 16xx or organohalogenated liquids under 1175. As a result, the products concerned no longer fall within the scope of the ICPE nomenclature, unless they have additional hazard properties covered by 4000 headings. By way of example :

• hydrochloric acid, previously classified under 1611, is now classified under 4130 as toxic by inhalation (H331)
• perchloroethylene, previously classified under heading 1175, is now classified under heading 4511 as an environmentally hazardous product (chronic category 2).

4) New named substances are covered by specific 4000 headings

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

All in all, with the exception of a few rare cases of 4000 headings equivalent to 1000 headings that have been removed (e.g.: Heading 1185 replaced by Heading 4802), all these changes make it inevitable for operators to carry out a new assessment of their ICPE classification, with a view in particular to asserting any prior rights.

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

Under the "acquired rights" rule [4], plants subject to a change of ICPE regime following a change in the nomenclature can continue to operate the existing facilities 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 grandfathering right now also applies in the event of a change in the ICPE regime resulting from a change in the hazard classification of products used or stored on site. In this case, the one-year period runs from the date of entry into force of the change in product classification, rather than from the date of publication of the decree amending the nomenclature. As the changes to the ICPE regime that may result from the application of the 4000 headings are linked to the entry into force of the new CLP classification of products on June¹, 2015, operators have until June^1, 2016 to inform the prefect of their new ICPE classification and assert their prior rights.

Grading methodology

To establish its new ICPE classification under the 4000 headings, an operator must proceed in 3 stages:

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

To find out and fill in the hazard properties of the hazardous substances and mixtures listed (classes, categories and hazard statements H), it is necessary to refer to section 2 of the safety data sheets (SDS):

One of the main difficulties for operators is to rapidly obtain updated SDS sheets incorporating CLP classification data for mixtures. In fact, for mixtures, suppliers have only been obliged to draw up SDSs based on CLP since June^1, 2015.

Another possibility is to refer to the list of harmonized classifications of substances in Annex VI of the CLP Regulation [5]. This list contains over 4,000 substances, whose classification and labeling rules are imposed on suppliers throughout Europe, including for mixtures containing them. However, the vast majority of substances available on the market are not included.

Identifying and classifying the hazardous wastes to be considered under 4000 headings can also be difficult, in the absence of SDS sheets and precise characterization data. However, these wastes have similar properties to raw materials, intermediates or finished products, and it must be possible to identify their categories and hazard statements under the CLP regulation, in order to determine the 4000 headings to which they belong.

2. Identify the 4000 headings corresponding to the hazardous substances and mixtures under consideration.

The operator must first determine whether any of the hazardous products listed include substances or mixtures specifically named in headings 47xx or 48xx. For products not specifically named in a 47xx or 48xx heading, the operator must then search for the 4100 to 4699 headings to which they may belong, according to their generic hazard properties (toxic, flammable, oxidizing, etc.). For this purpose, an INERIS guide [6] provides very useful tables establishing the correspondence between the H hazard statements assigned to hazardous products and the 4000 headings.

N.B.: A substance or mixture not mentioned by name in heading 47xx or 48xx and presenting several hazard statements associated with several headings 4100 to 4699, must be classified in priority in the heading presenting, in order of priority:

• the lowest Seveso high threshold
• in the case of equal Seveso high thresholds, the lowest Seveso low threshold
• in the case of equal Seveso low thresholds, the lowest Authorization threshold
• in the case of equal Authorization thresholds, the lowest Registration threshold
• in the case of equal Registration thresholds, the lowest Declaration threshold.

3. ICPE classification for each 4000 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 heading.

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

Determining Seveso status

In addition to the ICPE regime, the entry into force of the new ICPE nomenclature, and more specifically of the 4000 headings, may also have an impact on the Seveso status of certain facilities. In fact, the new breakdown of headings and the changes in product classification already described above also influence the conditions for assessing the Seveso Haut (SH) and Seveso Bas (SB) thresholds appearing at the end of each 4000 heading.

Thus, according to an initial estimate by the French Ministry of Ecology, 15% of plants are expected to leave the Seveso regime, while 15% are expected to enter it [7]. However, the criteria for determining the Seveso status of an establishment are still based on the same principles:

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

HOW TO DETERMINE SEVESO STATUS ACCORDING TO THE CUMULATIVE RULE?

The cumulative rule defined in Article R. 511-11 of the French Environment Code means that a Seveso SH or SB plant can be classified on the basis of the cumulative quantities of products presenting health, physical and/or environmental hazards, even if the Seveso thresholds set for each individual heading are not reached. In practice, however, this rule remains particularly complex to understand and apply. To help operators, the French Ministry of Ecology has developed a simulation tool that calculates the Seveso status of an establishment by entering the quantities of hazardous products present. Training materials including several examples of how to apply the accumulation rule are also available.

N.B.: Under heading 4001 of the ICPE nomenclature, any facility meeting the Seveso SH or SB cumulation rule is subject to Authorization. This means that Seveso-classified sites that do not have any ICPEs subject to this regime are now subject to the Authorization regime.

Implications for plants becoming Seveso

Seveso plants are subject to special safety regulations designed to prevent the risk of major accidents they are likely to cause, due to the large quantities of hazardous products involved. Slightly revised as of June^1, 2015, in application of the Seveso 3 directive, the procedures and requirements imposed on the operators concerned depend on the status of the facility. They are summarized in the table below:

Thus, a plant that becomes Seveso on June^1, 2015 under the 4000 headings of the ICPE nomenclature must :

• draw up an initial online inventory of hazardous substances and mixtures by December 31, 2015
• to have prepared its PPAM by June^1, 2016
• if it becomes Seveso SH, complete its SMS and POI by June^1, 2017.

Conclusion

This new overhaul of the ICPE nomenclature, with its many administrative and regulatory implications, illustrates, if proof were needed, the importance for companies of having a constantly updated inventory of their classified facilities in line with the headings in force. As an extension of our monitoring and compliance assessment services, the ICPE tracking functionality available in certain regulatory compliance software packages is specifically designed to facilitate this process.

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

[2] Regulation No. 1272/2008 of December 16, 2008 on classification, labeling 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 Environment Code

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

[6] Guide INERIS "Application de la classification des substances et mélanges dangereux à la nomenclature des ICPE", June 2014 (http://www.ineris.fr/centredoc/guide-technique---juin-2014-1404813170.pdf)

[7] According to figures from the French Ministry of Ecology, France had 1,205 Seveso plants on December 31, 2013, including 657 "Seuil Haut" plants.

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