Executive Order Nº 43. Regulation for the Storage of Hazardous Substances
On March 29th, 2016, Ex.Ord 43 from the Ministry of Health was published in the Official Gazette, which approves the Regulation for the Storage of Hazardous Substances. This new regulation came into force on September 26th, 2016, repealing Ex.Ord 78 from 2009 as of this date. In the event of having to modify the facilities to meet the requirements of the order, there is a 2-year term; whereas in the mining industry, which is a new element on the scope of this order, the term can be extended to five years.
Scope of the Regulation for the Storage of Hazardous Substances
The scope set by Ex.Ord 78 will be maintained, that is: it is applicable to the storage facilities of hazardous substances, the latter being understood as those defined in the Chilean Standard 382 of 2013. Radioactive substances, explosives, flammable liquids and gases, storage made in port unit, infectious substances (class 6 division 2 of the Chilean Standard 382-2012), bulk solids in extraction industry works (if included, the substances stored in the support services or facilities of such works) and alcoholic beverages with more than 24% alcohol, are expressly excluded from the application of this Order.
Furthermore, under this regulation, the application of the following Official Chilean Standards are included: Nch Nº 2245:2015, regarding the Product Safety Data Sheet and Nch Nº 382:2013 regarding Hazardous Substances.
The new regulation broadens the cases in which a health authorization is required for functioning, leaving the following cases subject to such authorization:
- Storage of hazardous substances above 10 tons of flammable substances or 30 tons of other kinds of hazardous substances. On this regard, the new regulation is less severe, whereas it increases the limit of tons of hazardous substances that can be stored without the need of a health authorization, from 12 tons (established in Ex.Ord. 78) to 30 tons.
- Storage of gasses in cylinders, when the effective area of storage is higher than 30 m2.
- Fixed tanks of a volume equal or superior to 15 m3, or when it is equal or superior to that amount but constituted by various tanks located at a distance equal or inferior to 5 m from each other.
- Container or iso-tank storage yard, when more than one unit is stored.
- Storage of bulk solids stacked outdoors, regardless of the amounts stored.
Once the authorization is obtained, an obligation to make statements twice a year persists. Likewise, the authority must be informed if there are modifications or if there is a temporal or permanent closure. When the closure is for a term higher than one year, the authorization shall expire.
Location and access
These facilities cannot be located on the following sites:
- Near nurseries or kindergartens.
- If there is a residence on the same site, it can only be used by workers, it must be at least 15 meters from the storage facilities and it must be separated by a barrier.
- In case of farming and foresting estates that have storage facilities, they can have a residence as long as it is located at a distance of at least 100 meters.
- In case of hazardous substances warehouses, it cannot contain offices inside.
The access to these facilities must be controlled. There will a person in charge of supervising the entrance of people and machinery, and of keeping a record of the products that enter and exit the facilities. Likewise, there must be a site location plan of the company visible at the main entrance.
Forms of Storage
The regulation maintains the distinction between three ways of storing, in accordance with the amounts that are stored. There are special requirements for each one of them.
Storage of small amounts:
Hazardous substances can be stored in packages placed directly on the floor or on a smooth non-absorbing material (with some exceptions that are listed in the regulation), in facilities that are not intended as warehouses, when their total amount does not exceed 600 Kg or Liters.
Storage in common warehouses:
A total amount of 12 tons of hazardous substances can be stored in these warehouses. Special limitations are established for certain substances in particular.
Storage in warehouses intended for hazardous substances:
When the hazardous substances exceed 12 tons they must be stored in special warehouses.
Special storing rules for hazardous substances
The regulation contains special guidelines for some cases of storage, namely: storage of gases, flammable liquids in packages, flammable solids in packages, oxidizers and organic peroxides in packages, substances that must be stored in bulk, storage in containers and iso-tanks and the storage of hazardous substances in commercial stores.
Chemical incompatibilities matrix
The order provides a matrix for determining the incompatibilities between different hazardous substances for the purpose of storing them.
The regulation is more demanding in matters of staff training. There is an obligation to train the personnel that works in these facilities at least once a year, while the former Ex.Ord.: 78 only required training every three years. The obligation of registering such training is maintained.
Picking, packing and production areas
New rules in relation to these matters were introduced. In this regard, when picking or packing takes place inside the warehouses, every security condition set forth by the regulation must be complied with. And also, the staff safety conditions set forth in Ex.Ord. 594 of the Health Department must be preserved.
Likewise, it has been set forth that, after picking, the packing of substances must be performed in a special area intended for that, where substances from other warehouses shall be forbidden.
Regarding the production areas, special regulations that specify the requirements for cases in which there is bulk storage in production or packing areas have been established.
Shower and eyewash systems for warehouses with hazardous substances
The obligation of having showers and emergency eye wash systems has been extended to common warehouses that store more than 6 tons of hazardous substances. Therefore, now both common warehouses with more than 6 tons and hazardous substances storages must have such system.
Fire detection and extinguishing system
The obligation of having an examination program for the fire detection and extinguishing system in hazardous substances warehouses is added. The minimum frequency for these examinations varies from 3 months to 1 year, depending on the system used.
Labelling of hazardous substances
There are a special set of rules of how to label hazardous substances. However, these rules do not apply to pharmaceuticals, cosmetics, which have their one set of rules. In case of imported hazardous substances, the importer is the one obliged to make sure these products comply with the labelling rules.
Labelling of hazardous substances
There are a special set of rules of how to label hazardous substances. However, these rules do not apply to pharmaceuticals, cosmetics, which have their one set of rules.
In case of imported hazardous substances, the importer is the one obliged to make sure these products comply with the labelling rules.
The information must be in Spanish and easy to read. The elements of the safety box containing the information must be highlighted from the background and must be arranged in a way that when the container is in its normal position, the information can be read horizontally.
Depending on the size of the hazardous substance’s container the size of the safety box, the pictogram for the hazard and the related information will vary. GHS can be used for labelling products as long as the information is in Spanish and also signs established by NCh2190 are also used.
Last modified: 11/01/2021